Music for Pain in Primary Dysmenorrhea

NCT ID: NCT03593850

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 649 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-04-17

Brief Summary

Primary dysmenorrhea is defined as lower abdominal pain that occurs during menses and is not secondary to any type of pelvic disease. It is considered the most common condition in reproductive age women. First line of treatment are non-steroidal anti-inflammatory drugs (NSAIDS), or oral contraceptives (OCC). This two forms of treatment have not demonstrated 100% efficacy, and adverse events and contraindications for both exist. Moreover, studies have demonstrated that an important women do not use, or don't like to use, pharmacological treatment. Music have demonstrated analgesic effects in different clinical contexts, and has emerged as an important form of complementary therapy in the management of pain. To the researcher's knowledge, no studies have been conducted to evaluate music's effectiveness in pain secondary to primary dysmenorrhea.

The following is the protocol for a randomized, single blinded, clinical trial, where an experimental group listened to a 30 minute song, and was compared to a control group that rest in silence for the same time and conditions. It was expected that music will produce a larger, and significant, effect on pain reduction when compared to the control silence group according to pain measured through a 10 cm Visual Analogue Scale (VAS) in young women from the School of Medicine and Health Sciences at the Universidad del Rosario, Bogota DC, Colombia. Additionally, the investigators wanted to evaluate the clinical effect of music and analgesic requirements, anxiety and vital signs were also measured.

Detailed Description

Primary Dysmenorrhea (PD) is defined as pain in the lower abdomen, that occurs always during menses, in the absence of pelvic pathology, and lasts about 24-72 hours. It initiates during the first 24 months after menarche. Other symptoms like, emotional lability, anxiety, nausea, headache, and others may accompany the pain. It is considered the most common condition of reproductive age women, and is considered one of the most important causes for school or work absence in this population.

Music has been proposed as a complementary therapy for the management of pain, and a large body of clinical evidence supports its use on clinical context. Additionally, functional imaging research has found that music activates areas related to pain modulation and perception like the periaqueductal gray matter. Moreover music seems to modify brain activity during pain perception. Music has been shown to be effective in relieving pain secondary to surgery, in cancer related pain, and other types of pain, but it has not been studied for primary dysmenorrhea.

This randomized clinical trial was designed with the following objectives

General Objective: To evaluate the efficacy of music listening, compared to a control group that rested in silence, in the painful experience secondary to primary dysmenorrhea in women of 18 years or older from the School of Medicine and Health Sciences at the Universidad del Rosario, Bogotá DC., Colombia.

Specific Objectives:

1. Description of demographic data, clinical, gynecological, and obstetric background from the study population.

2. Description of pain management, secondary to PD, used by the study population.

3. Evaluate the usual pain secondary to PD, as reported by the study participants through a Visual Analogue Scale (VAS)

4. To explore if the acute perception of pain secondary to PD, as reported by participants using a VAS, before the intervention, is different between the study groups.

5. To evaluate if the acute perception of pain secondary to PD, as reported by participants using a VAS, after the intervention, differs between those that listened to music and those that rested in silence.

6. To explore if a difference in the reduction of pain, as reported by participants using a VAS, from the moment before to the moment after the intervention exists between those in the music group compared to those in the silence group.

7. To evaluate if the acute perception of pain secondary to PD, as reported by participants using a VAS, 3-6 hours after the intervention, differs between those that listened to music and those that rested in silence.

8. To evaluate if the anxiety secondary to PD, as reported by participants using a validated Spanish short version of the Zung scale, differs between groups, before and after the intervention.

9. To evaluate if a difference in the reported requirements of analgesic drugs is different between the study groups after and 3-6 hours after the intervention.

10. To evaluate if a difference in heart rate, systolic and diastolic blood pressure is identified between groups, using a previously calibrated digital sphyngmomanometer.

The investigators hypothesized that listening to an instrumental song, unknown to the patient, will have a significant effect on pain relief. Additionally, investigators hypothesized that music listening will have a clinical effect big enough to also impact analgesic requirements and anxiety scores .

Primary endpoint was pain reduction from the moment before to after the intervention. Pain reduction is the better way to evaluate analgesia efficacy and was the proper approach for these protocol's main objective, which was efficacy of music on pain relief secondary to primary dysmenorrhea.

For achieving these aims and answering research questions, a randomized clinical trial was designed. As patients can't be blinded from listening or not to music, a single blinded approach was decided. Furthermore, methodology for recruitment was designed to blind patients from allocation until the day of the intervention and a speech was used to avoid patients to identify the primary endpoint. Additionally, patients were explained that two interventions were used, but it was not specified that silence group was the control group, to assure proper blinding and avoid further bias of results. Silence was decided as a control intervention as comparison with drug placebo may not be adequate due to differences in the types of intervention.

To isolate the music effects the investigators decided on using a completely new and unknown song. The song was planned and composed exclusively for the research, so all patients allocated to the music group listened to the exact same musical piece.

Conditions

Pain, Menstrual; Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Music group

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Silence Group

Intervention Type: BEHAVIORAL

Audio file that contained no sounds.

Interventions

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).

Intervention Type: BEHAVIORAL

Silence Group

Audio file that contained no sounds.

Intervention Type: BEHAVIORAL

Other Intervention Names

Occasio adolore; Silence

Eligibility Criteria

Inclusion Criteria

• Legal and cognitive capacity for informed consent.
• Suffering from primary dysmenorrhea (low abdominal pain associated to menses).
• Being able to understand and use the measuring tools and questionnaires.

Exclusion Criteria

• Previous diagnosis of pelvic pathology.
• Diagnosis of hearing impairment.
• Diagnosis of neurologic or endocrinological disease.
• Psychiatric condition diagnosed.
• Known or reported previous substance abuse.
• Current use of psychiatric drugs.
• Cancer diagnosis
• Diagnosed diabetes mellitus or heart disease.
• Previous advance musical training (defined as any form of music training in addition to that received during normal school classes).
• Irregular menstrual cycles.
• Previous pregnancy.
• Current use or use of any hormonal contraceptive therapy in the last 2 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad del Rosario

OTHER

Sponsor Role: lead

Responsible Party

Juan S. Martin-Saavedra

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan S Martin-Saavedra, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad del Rosario

Angela M Ruiz-Sternberg, MD, MSc

Role: STUDY_DIRECTOR

Universidad del Rosario

Locations

Escuela de Medicina y Ciencias de la Salud- Universidad del Rosario

Bogotá, Capital District, Colombia

Countries

Colombia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CEI856

Identifier Type: -

Identifier Source: org_study_id