Trial Outcomes & Findings for Music for Pain in Primary Dysmenorrhea (NCT NCT03593850)
NCT ID: NCT03593850
Last Updated: 2024-05-28
Results Overview
Pain scores were measured using a visual analogue scale (VAS) of 10 cm (0 no pain at all, and 10 the worst possible pain) at each time point. Main outcome was calculated from the difference between visual analogue score at 1-5 minutes after (VAS3) minus visual analogue score at 1-5 minutes before the intervention (VAS2).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
649 participants
Primary outcome timeframe
From 1-5 minutes before the intervention (baseline) to 1-5 minutes after the intervention.
Results posted on
2024-05-28
Participant Flow
Patients were recruited and between September 2017 to April 2018 from the School of Medicine and Health Sciences, and the School of Mathematics and Natural Sciences from Universidad del Rosario. Assessment, data collection, and intervention occurred within the facilities of the School of Medicine and Health Sciences from Universidad del Rosario, Bogota D.C., Colombia.
A total of 597 participants were excluded: 470 did not met inclusion criteria, 98 declined to participate, and 29 signed consent but never came for randomization and the intervention.
Participant milestones
| Measure |
Music Group
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Primary Endpoint
STARTED
|
29
|
23
|
|
Primary Endpoint
Received Allocated Intervention and Completed Post-intervention Outcomes (Primary Endpoint)
|
29
|
23
|
|
Primary Endpoint
COMPLETED
|
29
|
22
|
|
Primary Endpoint
NOT COMPLETED
|
0
|
1
|
|
3-6 Hours Post Intervention Outcomes
STARTED
|
29
|
22
|
|
3-6 Hours Post Intervention Outcomes
COMPLETED
|
27
|
19
|
|
3-6 Hours Post Intervention Outcomes
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Music Group
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
3-6 Hours Post Intervention Outcomes
Did not returned or filled wrongly the outcome questionnaire
|
2
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.1 years
STANDARD_DEVIATION 2.27 • n=29 Participants
|
19.57 years
STANDARD_DEVIATION 1.31 • n=23 Participants
|
19.87 years
STANDARD_DEVIATION 1.91 • n=52 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=29 Participants
|
23 Participants
n=23 Participants
|
52 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=29 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Colombia
|
29 participants
n=29 Participants
|
23 participants
n=23 Participants
|
52 participants
n=52 Participants
|
|
University program
Medicine
|
6 Participants
n=29 Participants
|
10 Participants
n=23 Participants
|
16 Participants
n=52 Participants
|
|
University program
Phonoaudiology
|
5 Participants
n=29 Participants
|
7 Participants
n=23 Participants
|
12 Participants
n=52 Participants
|
|
University program
Physiotherapy
|
8 Participants
n=29 Participants
|
4 Participants
n=23 Participants
|
12 Participants
n=52 Participants
|
|
University program
Psychology
|
5 Participants
n=29 Participants
|
2 Participants
n=23 Participants
|
7 Participants
n=52 Participants
|
|
University program
Other (Epidemiology, Gynecology, Biology)
|
5 Participants
n=29 Participants
|
0 Participants
n=23 Participants
|
5 Participants
n=52 Participants
|
|
Academic semester
First to Fifth
|
21 Participants
n=29 Participants
|
15 Participants
n=23 Participants
|
36 Participants
n=52 Participants
|
|
Academic semester
Sixth to Tenth
|
8 Participants
n=29 Participants
|
8 Participants
n=23 Participants
|
16 Participants
n=52 Participants
|
|
Presence of comorbidities
Yes
|
4 Participants
n=29 Participants
|
3 Participants
n=23 Participants
|
7 Participants
n=52 Participants
|
|
Presence of comorbidities
No
|
25 Participants
n=29 Participants
|
20 Participants
n=23 Participants
|
45 Participants
n=52 Participants
|
|
History of surgeries in their lifetime
Yes
|
9 Participants
n=29 Participants
|
6 Participants
n=23 Participants
|
15 Participants
n=52 Participants
|
|
History of surgeries in their lifetime
No
|
20 Participants
n=29 Participants
|
17 Participants
n=23 Participants
|
37 Participants
n=52 Participants
|
|
Age at menarche
|
12.14 years
STANDARD_DEVIATION 1.51 • n=29 Participants
|
12.17 years
STANDARD_DEVIATION 1.11 • n=23 Participants
|
12.15 years
STANDARD_DEVIATION 1.33 • n=52 Participants
|
|
Intermenstrual time
|
29.07 days
STANDARD_DEVIATION 2.59 • n=29 Participants
|
29.13 days
STANDARD_DEVIATION 1.74 • n=23 Participants
|
29.1 days
STANDARD_DEVIATION 2.23 • n=52 Participants
|
|
Duration of menses
|
5.03 days
STANDARD_DEVIATION 1.32 • n=29 Participants
|
5.22 days
STANDARD_DEVIATION 1.28 • n=23 Participants
|
5.11 days
STANDARD_DEVIATION 1.29 • n=52 Participants
|
|
Type of menstrual pain
Oppressive-like
|
6 Participants
n=29 Participants
|
7 Participants
n=23 Participants
|
13 Participants
n=52 Participants
|
|
Type of menstrual pain
Colic-like
|
18 Participants
n=29 Participants
|
12 Participants
n=23 Participants
|
30 Participants
n=52 Participants
|
|
Type of menstrual pain
Mixed
|
5 Participants
n=29 Participants
|
4 Participants
n=23 Participants
|
9 Participants
n=52 Participants
|
|
First ever menstrual pain
1-2 years after menarche
|
14 Participants
n=29 Participants
|
7 Participants
n=23 Participants
|
21 Participants
n=52 Participants
|
|
First ever menstrual pain
At the time of menarche
|
9 Participants
n=29 Participants
|
6 Participants
n=23 Participants
|
15 Participants
n=52 Participants
|
|
First ever menstrual pain
1-6 months after menarche
|
2 Participants
n=29 Participants
|
8 Participants
n=23 Participants
|
10 Participants
n=52 Participants
|
|
First ever menstrual pain
6-12 months after menarche
|
3 Participants
n=29 Participants
|
1 Participants
n=23 Participants
|
4 Participants
n=52 Participants
|
|
First ever menstrual pain
Other
|
1 Participants
n=29 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=52 Participants
|
|
Menstrual pain onset
Same day
|
14 Participants
n=29 Participants
|
6 Participants
n=23 Participants
|
20 Participants
n=52 Participants
|
|
Menstrual pain onset
24 hours after
|
8 Participants
n=29 Participants
|
5 Participants
n=23 Participants
|
13 Participants
n=52 Participants
|
|
Menstrual pain onset
Less than 24 hours before
|
3 Participants
n=29 Participants
|
6 Participants
n=23 Participants
|
9 Participants
n=52 Participants
|
|
Menstrual pain onset
48-24 hours before
|
1 Participants
n=29 Participants
|
6 Participants
n=23 Participants
|
7 Participants
n=52 Participants
|
|
Menstrual pain onset
Other
|
3 Participants
n=29 Participants
|
0 Participants
n=23 Participants
|
3 Participants
n=52 Participants
|
|
Menstrual pain duration
10-24 hours
|
11 Participants
n=29 Participants
|
7 Participants
n=23 Participants
|
18 Participants
n=52 Participants
|
|
Menstrual pain duration
24-48 hours
|
9 Participants
n=29 Participants
|
6 Participants
n=23 Participants
|
15 Participants
n=52 Participants
|
|
Menstrual pain duration
Less than 10 hours
|
5 Participants
n=29 Participants
|
7 Participants
n=23 Participants
|
12 Participants
n=52 Participants
|
|
Menstrual pain duration
48-72 hours
|
3 Participants
n=29 Participants
|
2 Participants
n=23 Participants
|
5 Participants
n=52 Participants
|
|
Menstrual pain duration
Other
|
1 Participants
n=29 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=52 Participants
|
|
Analgesic used on last menstrual period
Yes
|
12 Participants
n=29 Participants
|
17 Participants
n=23 Participants
|
29 Participants
n=52 Participants
|
|
Analgesic used on last menstrual period
No
|
17 Participants
n=29 Participants
|
6 Participants
n=23 Participants
|
23 Participants
n=52 Participants
|
|
Non-pharmacologic treatment used in last menstrual period
Yes
|
10 Participants
n=29 Participants
|
11 Participants
n=23 Participants
|
21 Participants
n=52 Participants
|
|
Non-pharmacologic treatment used in last menstrual period
No
|
19 Participants
n=29 Participants
|
12 Participants
n=23 Participants
|
31 Participants
n=52 Participants
|
|
Usual menstrual pain - Visual Analogue Scale (VAS1)
|
6.34 units on a scale
STANDARD_DEVIATION 1.69 • n=29 Participants
|
6.76 units on a scale
STANDARD_DEVIATION 1.77 • n=23 Participants
|
6.549 units on a scale
STANDARD_DEVIATION 1.71 • n=52 Participants
|
|
Analgesia 1
Yes
|
12 Participants
n=29 Participants
|
11 Participants
n=23 Participants
|
23 Participants
n=52 Participants
|
|
Analgesia 1
No
|
17 Participants
n=29 Participants
|
12 Participants
n=23 Participants
|
29 Participants
n=52 Participants
|
|
Pain pre-intervention - Visual Analogue Scale (VAS2)
|
4.82 units on a scale
STANDARD_DEVIATION 2.04 • n=29 Participants
|
4.97 units on a scale
STANDARD_DEVIATION 1.9 • n=23 Participants
|
4.887 units on a scale
STANDARD_DEVIATION 2.205 • n=52 Participants
|
|
Anxiety (A1) - Abbreviated Zung anxiety scale
|
1.8 units on a scale
STANDARD_DEVIATION 0.37 • n=29 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 0.44 • n=23 Participants
|
1.86 units on a scale
STANDARD_DEVIATION 0.38 • n=52 Participants
|
|
Hours with pain
|
6.27 hours
STANDARD_DEVIATION 5.84 • n=29 Participants
|
6 hours
STANDARD_DEVIATION 5.04 • n=23 Participants
|
6.15 hours
STANDARD_DEVIATION 5.44 • n=52 Participants
|
|
Systolic blood pressure
|
108.97 mmHg
STANDARD_DEVIATION 11.98 • n=29 Participants • Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted
|
105.59 mmHg
STANDARD_DEVIATION 10.97 • n=22 Participants • Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted
|
107.51 mmHg
STANDARD_DEVIATION 11.56 • n=51 Participants • Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted
|
|
Diastolic blood pressure
|
71.1 mmHg
STANDARD_DEVIATION 10.79 • n=29 Participants • Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted
|
68.14 mmHg
STANDARD_DEVIATION 9.88 • n=22 Participants • Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted
|
69.82 mmHg
STANDARD_DEVIATION 10.41 • n=51 Participants • Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted
|
|
Mean arterial blood pressure
|
83.83 mmHg
STANDARD_DEVIATION 10.32 • n=29 Participants • Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted
|
80.62 mmHg
STANDARD_DEVIATION 9.31 • n=22 Participants • Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted
|
82.39 mmHg
STANDARD_DEVIATION 9.96 • n=51 Participants • Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted
|
|
Heart rate
|
75.48 bpm
STANDARD_DEVIATION 12.56 • n=29 Participants • Measured heart rate in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention was deleted
|
75.68 bpm
STANDARD_DEVIATION 11.87 • n=22 Participants • Measured heart rate in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention was deleted
|
75.62 bpm
STANDARD_DEVIATION 12.16 • n=51 Participants • Measured heart rate in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention was deleted
|
PRIMARY outcome
Timeframe: From 1-5 minutes before the intervention (baseline) to 1-5 minutes after the intervention.Population: Intention to treat analysis used
Pain scores were measured using a visual analogue scale (VAS) of 10 cm (0 no pain at all, and 10 the worst possible pain) at each time point. Main outcome was calculated from the difference between visual analogue score at 1-5 minutes after (VAS3) minus visual analogue score at 1-5 minutes before the intervention (VAS2).
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Change in Pain From 1-5 Minutes Before (Baseline) to 1- 5 Minutes After the Intervention
|
-1.85 cm
Standard Deviation 1.78
|
-0.18 cm
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 5-10 minutes before the intervention.Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Usual pain was evaluated before the intervention and was known as VAS 1.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Usual Pain Associated to Menses
|
6.34 cm
Standard Deviation 1.69
|
6.76 cm
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: 1-5 minutes before the intervention.Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated immediately before the intervention and was known as VAS 2.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Actual Pain 1-5 Minutes Before the Intervention (Baseline).
|
4.82 cm
Standard Deviation 2.04
|
4.97 cm
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: 1-5 minutes after the intervention.Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated immediately after the intervention was completed, and was known as VAS 3.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Actual Pain 1-5 Minutes After the Intervention.
|
2.97 units on a scale
Standard Deviation 2.15
|
4.77 units on a scale
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: 3-6 hours after the intervention.Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated 3-6 hours after the intervention was completed, and was known as VAS 4.
Outcome measures
| Measure |
Music Group
n=27 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=19 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Actual Pain 3-6 Hours After the Intervention.
|
2.37 units on a scale
Standard Deviation 2.31
|
3.63 units on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 1-5 minutes before the intervention.Using a validated short spanish version of the Zung anxiety scale, anxiety was measured before the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (0= never, 1= some times, 2= most of the time, and 3 = always). Final scores ranged from 0, minimum anxiety, and 30 maximum anxiety.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Anxiety Score Before the Intervention
|
1.8 score on a scale
Standard Deviation 0.37
|
1.9 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 1-5 minutes after the intervention.Using a validated short spanish version of the Zung anxiety scale, anxiety was measured after the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (1= never, 2= some times, 3= most of the time, and 4 = always). Scores ranged from 10, minimum anxiety, and 40 maximum anxiety. For analysis, mean quantitative scores were obtained so 1 was equivalent to minimum anxiety, and 4 to maximum anxiety.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Anxiety Score After the Intervention
|
1.53 score on a scale
Standard Deviation 0.33
|
1.73 score on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 3-6 hours after fter the intervention.Using a validated short spanish version of the Zung anxiety scale, anxiety was measured 3-6 hours after the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (0= never, 1= some times, 2= most of the time, and 3= always). Scores ranged from 0, minimum anxiety, and 30 maximum anxiety.
Outcome measures
| Measure |
Music Group
n=27 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=19 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Anxiety Score 3-6 Hours After the Intervention
|
1.49 score on a scale
Standard Deviation 0.29
|
1.62 score on a scale
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 1-5 minutes before the intervention the intervention.Before the intervention patients were asked if they wanted to use any analgesic drug or do any kind of analgesic strategy. Patients simply answered yes or no.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Analgesic Requirements Before
Yes
|
12 Participants
|
11 Participants
|
|
Analgesic Requirements Before
No
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 1-5 minutes after the intervention.After the intervention patients were asked if they wanted to use any analgesic drug or do any kind of analgesic strategy. Patients simply answered yes or no.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Analgesic Requirements After
Yes
|
4 Participants
|
10 Participants
|
|
Analgesic Requirements After
No
|
25 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 3-6 hours after the intervention)After the intervention, all patients had to register all analgesic drugs (e.g. ibuprofen) or strategy (e.g. local heat) that were used until last pain measurement (VAS 4, 3-6 hours after the intervention).
Outcome measures
| Measure |
Music Group
n=27 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=19 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Analgesic Use During a Period of 3-6 Hours After the Intervention.
Yes
|
6 Participants
|
11 Participants
|
|
Analgesic Use During a Period of 3-6 Hours After the Intervention.
No
|
21 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 1-5 minutes before the intervention.Systolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Systolic Blood Pressure Before the Intervention
|
108.97 mmHg
Standard Deviation 11.98
|
105.59 mmHg
Standard Deviation 10.97
|
SECONDARY outcome
Timeframe: 1-5 minutes before the intervention.Diastolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Diastolic Blood Pressure Before the Intervention
|
71.1 mmHg
Standard Deviation 10.79
|
68.14 mmHg
Standard Deviation 9.88
|
SECONDARY outcome
Timeframe: 1-5 minutes before the intervention.Heart rate measured in beats per minute (bpm) with a calibrated digital sphygmomanometer before the intervention.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Heart Rate Before the Intervention
|
75.48 bpm
Standard Deviation 12.56
|
75.68 bpm
Standard Deviation 11.87
|
SECONDARY outcome
Timeframe: 1-5 minutes before the intervention.Mean blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Mean Blood Pressure Before the Intervention
|
83.83 mmHg
Standard Deviation 10.32
|
80.62 mmHg
Standard Deviation 75.68
|
SECONDARY outcome
Timeframe: 1-5 minutes after the intervention.Systolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Systolic Blood Pressure After the Intervention
|
109.66 mmHg
Standard Deviation 14.04
|
103.26 mmHg
Standard Deviation 9.66
|
SECONDARY outcome
Timeframe: 1-5 minutes after the intervention.Diastolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Diastolic Blood Pressure After the Intervention
|
69.9 mmHg
Standard Deviation 9.39
|
65.26 mmHg
Standard Deviation 7.19
|
SECONDARY outcome
Timeframe: 1-5 minutes after the intervention.Heart rate in beats per minute (bpm) measured with a calibrated digital sphygmomanometer after the intervention.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Heart Rate After the Intervention
|
74.48 bpm
Standard Deviation 11.22
|
74.96 bpm
Standard Deviation 12.32
|
SECONDARY outcome
Timeframe: 1-5 minutes after the intervention.Mean blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention.
Outcome measures
| Measure |
Music Group
n=29 Participants
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
|
Silence Group
n=23 Participants
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Silence Group: Audio file that contained no sounds.
|
|---|---|---|
|
Mean Blood Pressure After the Intervention
|
83.04 mmHg
Standard Deviation 10.22
|
77.92 mmHg
Standard Deviation 6.77
|
Adverse Events
Music Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Silence Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Juan Sebastian Martin Saavedra
Universidad del Rosario
Phone: 2672200532
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place