Trial Outcomes & Findings for Musically-Guided Paced Breathing Improves Mental Health in War-Affected Adolescents (NCT NCT06988800)
NCT ID: NCT06988800
Last Updated: 2025-10-14
Results Overview
As the primary outcomes measure, participants will complete the Revised Children's Manifest Anxiety Scale (RCMAS) self-report questionnaire. The RCMAS lists 37 feelings or actions and participants respond "yes" if that item is typical of their own feelings/actions, or "no" if not. The RCMAS produces a total anxiety score and three subscales: physiological anxiety, worry/oversensitivity, and social concerns/concentration. The Arabic version of the RCMAS has shown to have acceptable reliability and validity in youth. The score ranges from 0-37, with a higher score indicating greater anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
213 participants
Primary outcome timeframe
From enrollment to the end of treatment at 12 weeks
Results posted on
2025-10-14
Participant Flow
Students were included in this study if they were children aged 13-17 years and enrolled in January 2024 at a school in a war-torn area in the West Bank in the Middle East.
Participant milestones
| Measure |
Guided Paced Breathing Audiovisual Intervention
Paced Breathing intervention delivered
Paced breathing wellness breathing sessions: The paced breathing condition used timed auditory and visual cues to guide participants through breathing cycles at a rate of five breaths per minute, designed to stimulate the parasympathetic nervous system and promote relaxation. The audiovisual cues included spoken instructions, music, and breath-like sounds. The tonal audio cues rose in pitch during inhalation and fell during exhalation, creating a clear auditory signal for breath pacing. The same harmonic drone used in the mindfulness intervention provided a calming background, though here it was combined with the rhythmic pacing. Visually, the pacing was synchronized with the image of a lotus flower opening during inhalation and closing during exhalation, reinforcing the breathing rhythm.
|
Guided Mindfulness Audiovisual Intervention
Mindfulness intervention delivered
Mindfulness video sessions: The audio component of the mindfulness intervention featured a female narrator guiding participants through mindfulness exercises, focusing on breath awareness and cultivating non-judgmental attention to thoughts and feelings. Ambient tonal sounds, including a harmonic drone with slow timbral changes, played softly in the background to support relaxation. Importantly, no rhythmic audio cues were included to avoid inducing breathing entrainment. This setup emphasized passive, mindful observation rather than active breath control, encouraging participants to observe their bodily sensations and thoughts without judgment.
|
Control
Participants in the control condition completed other typical after-school activities while participants in the intervention condition completed one of two breathing interventions: paced breathing (paced), or mindful breathing (mindfulness). Participants in the control condition were given the opportunity to complete the intervention after the study ended.
|
|---|---|---|---|
|
Intervention Period 1 - 5 Weeks
STARTED
|
64
|
77
|
72
|
|
Intervention Period 1 - 5 Weeks
COMPLETED
|
64
|
77
|
72
|
|
Intervention Period 1 - 5 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
|
Intervention Period 2 - 2 Weeks
STARTED
|
64
|
77
|
72
|
|
Intervention Period 2 - 2 Weeks
COMPLETED
|
64
|
77
|
72
|
|
Intervention Period 2 - 2 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Guided Paced Breathing Audiovisual Intervention
n=64 Participants
Paced Breathing intervention delivered
Paced breathing wellness breathing sessions: The paced breathing condition used timed auditory and visual cues to guide participants through breathing cycles at a rate of five breaths per minute, designed to stimulate the parasympathetic nervous system and promote relaxation. The audiovisual cues included spoken instructions, music, and breath-like sounds. The tonal audio cues rose in pitch during inhalation and fell during exhalation, creating a clear auditory signal for breath pacing. The same harmonic drone used in the mindfulness intervention provided a calming background, though here it was combined with the rhythmic pacing. Visually, the pacing was synchronized with the image of a lotus flower opening during inhalation and closing during exhalation, reinforcing the breathing rhythm.
|
Guided Mindfulness Audiovisual Intervention
n=77 Participants
Mindfulness intervention delivered
Mindfulness video sessions: The audio component of the mindfulness intervention featured a female narrator guiding participants through mindfulness exercises, focusing on breath awareness and cultivating non-judgmental attention to thoughts and feelings. Ambient tonal sounds, including a harmonic drone with slow timbral changes, played softly in the background to support relaxation. Importantly, no rhythmic audio cues were included to avoid inducing breathing entrainment. This setup emphasized passive, mindful observation rather than active breath control, encouraging participants to observe their bodily sensations and thoughts without judgment.
|
Control
n=72 Participants
Participants in the control condition completed other typical after-school activities while participants in the intervention condition completed one of two breathing interventions: paced breathing (paced), or mindful breathing (mindfulness). Participants in the control condition were given the opportunity to complete the intervention after the study ended.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.81 years
STANDARD_DEVIATION .99 • n=64 Participants
|
13 years
STANDARD_DEVIATION 1.1 • n=77 Participants
|
14.45 years
STANDARD_DEVIATION .97 • n=72 Participants
|
13.75 years
STANDARD_DEVIATION 1.19 • n=213 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=64 Participants
|
38 Participants
n=77 Participants
|
38 Participants
n=72 Participants
|
112 Participants
n=213 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=64 Participants
|
39 Participants
n=77 Participants
|
34 Participants
n=72 Participants
|
101 Participants
n=213 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Palestine
|
64 participants
n=64 Participants
|
77 participants
n=77 Participants
|
72 participants
n=72 Participants
|
213 participants
n=213 Participants
|
|
Self-Efficacy Questionnaire for Children
|
56.67 units on a scale
STANDARD_DEVIATION 15.92 • n=64 Participants
|
53.76 units on a scale
STANDARD_DEVIATION 19.4 • n=77 Participants
|
54.9 units on a scale
STANDARD_DEVIATION 17.29 • n=72 Participants
|
55.05 units on a scale
STANDARD_DEVIATION 17.64 • n=213 Participants
|
|
Patient Health Questionnaire-9
|
10.62 units on a scale
STANDARD_DEVIATION 5.64 • n=64 Participants
|
9.44 units on a scale
STANDARD_DEVIATION 6.57 • n=77 Participants
|
10.09 units on a scale
STANDARD_DEVIATION 6.59 • n=72 Participants
|
10.03 units on a scale
STANDARD_DEVIATION 6.29 • n=213 Participants
|
|
Revised Children's Manifest Anxiety Scale
|
17.61 units on a scale
STANDARD_DEVIATION 8.13 • n=64 Participants
|
18.67 units on a scale
STANDARD_DEVIATION 8.73 • n=77 Participants
|
17.64 units on a scale
STANDARD_DEVIATION 8.39 • n=72 Participants
|
18 units on a scale
STANDARD_DEVIATION 8.41 • n=213 Participants
|
PRIMARY outcome
Timeframe: From enrollment to the end of treatment at 12 weeksAs the primary outcomes measure, participants will complete the Revised Children's Manifest Anxiety Scale (RCMAS) self-report questionnaire. The RCMAS lists 37 feelings or actions and participants respond "yes" if that item is typical of their own feelings/actions, or "no" if not. The RCMAS produces a total anxiety score and three subscales: physiological anxiety, worry/oversensitivity, and social concerns/concentration. The Arabic version of the RCMAS has shown to have acceptable reliability and validity in youth. The score ranges from 0-37, with a higher score indicating greater anxiety.
Outcome measures
| Measure |
Guided Paced Breathing Audiovisual Intervention
n=64 Participants
Paced Breathing intervention delivered
Paced breathing wellness breathing sessions: The paced breathing condition used timed auditory and visual cues to guide participants through breathing cycles at a rate of five breaths per minute, designed to stimulate the parasympathetic nervous system and promote relaxation. The audiovisual cues included spoken instructions, music, and breath-like sounds. The tonal audio cues rose in pitch during inhalation and fell during exhalation, creating a clear auditory signal for breath pacing. The same harmonic drone used in the mindfulness intervention provided a calming background, though here it was combined with the rhythmic pacing. Visually, the pacing was synchronized with the image of a lotus flower opening during inhalation and closing during exhalation, reinforcing the breathing rhythm.
|
Guided Mindfulness Audiovisual Intervention
n=77 Participants
Mindfulness intervention delivered
Mindfulness video sessions: The audio component of the mindfulness intervention featured a female narrator guiding participants through mindfulness exercises, focusing on breath awareness and cultivating non-judgmental attention to thoughts and feelings. Ambient tonal sounds, including a harmonic drone with slow timbral changes, played softly in the background to support relaxation. Importantly, no rhythmic audio cues were included to avoid inducing breathing entrainment. This setup emphasized passive, mindful observation rather than active breath control, encouraging participants to observe their bodily sensations and thoughts without judgment.
|
Control
n=72 Participants
Participants in the control condition completed other typical after-school activities while participants in the intervention condition completed one of two breathing interventions: paced breathing (paced), or mindful breathing (mindfulness). Participants in the control condition were given the opportunity to complete the intervention after the study ended.
|
|---|---|---|---|
|
Revised Children's Manifest Anxiety Scale (RCMAS)
|
24.88 units on a scale
Standard Deviation 6.61
|
26.2 units on a scale
Standard Deviation 5.82
|
17.91 units on a scale
Standard Deviation 8.28
|
PRIMARY outcome
Timeframe: From enrollment to the end of treatment at 12 weeksAs a secondary outcome measure, a translated version of the Self-Efficacy Questionnaire for Children (SEQ-C) will be used. The SEQ-C includes three 8-item scales that measure academic, social, and emotional self-efficacy. The academic self-efficacy scale includes questions about the person's perception of achieving academic goals. The social self-efficacy scale addresses social challenges, and the emotional self-efficacy scale includes questions about coping with unpleasant problems or events. The subscale totals are added for a total score, ranging from 0-72, with a higher score being a positive indicator of greater self-efficacy.
Outcome measures
| Measure |
Guided Paced Breathing Audiovisual Intervention
n=64 Participants
Paced Breathing intervention delivered
Paced breathing wellness breathing sessions: The paced breathing condition used timed auditory and visual cues to guide participants through breathing cycles at a rate of five breaths per minute, designed to stimulate the parasympathetic nervous system and promote relaxation. The audiovisual cues included spoken instructions, music, and breath-like sounds. The tonal audio cues rose in pitch during inhalation and fell during exhalation, creating a clear auditory signal for breath pacing. The same harmonic drone used in the mindfulness intervention provided a calming background, though here it was combined with the rhythmic pacing. Visually, the pacing was synchronized with the image of a lotus flower opening during inhalation and closing during exhalation, reinforcing the breathing rhythm.
|
Guided Mindfulness Audiovisual Intervention
n=77 Participants
Mindfulness intervention delivered
Mindfulness video sessions: The audio component of the mindfulness intervention featured a female narrator guiding participants through mindfulness exercises, focusing on breath awareness and cultivating non-judgmental attention to thoughts and feelings. Ambient tonal sounds, including a harmonic drone with slow timbral changes, played softly in the background to support relaxation. Importantly, no rhythmic audio cues were included to avoid inducing breathing entrainment. This setup emphasized passive, mindful observation rather than active breath control, encouraging participants to observe their bodily sensations and thoughts without judgment.
|
Control
n=72 Participants
Participants in the control condition completed other typical after-school activities while participants in the intervention condition completed one of two breathing interventions: paced breathing (paced), or mindful breathing (mindfulness). Participants in the control condition were given the opportunity to complete the intervention after the study ended.
|
|---|---|---|---|
|
Self-Efficacy Questionnaire for Children (SEQ-C)
|
64.81 units on a scale
Standard Deviation 16.15
|
64.65 units on a scale
Standard Deviation 14.97
|
49.7 units on a scale
Standard Deviation 20.29
|
PRIMARY outcome
Timeframe: From enrollment to the end of treatment at 12 weeksA validated measure of depressive symptoms, consisting of nine items assessing the frequency of depressive symptoms over the past two weeks. The PHQ-9 has demonstrated strong psychometric properties, including reliability and validity in clinical and non-clinical populations, including the translated Arabic version. Scores range from 0-27, with a higher score indicating more depressive symptoms.
Outcome measures
| Measure |
Guided Paced Breathing Audiovisual Intervention
n=64 Participants
Paced Breathing intervention delivered
Paced breathing wellness breathing sessions: The paced breathing condition used timed auditory and visual cues to guide participants through breathing cycles at a rate of five breaths per minute, designed to stimulate the parasympathetic nervous system and promote relaxation. The audiovisual cues included spoken instructions, music, and breath-like sounds. The tonal audio cues rose in pitch during inhalation and fell during exhalation, creating a clear auditory signal for breath pacing. The same harmonic drone used in the mindfulness intervention provided a calming background, though here it was combined with the rhythmic pacing. Visually, the pacing was synchronized with the image of a lotus flower opening during inhalation and closing during exhalation, reinforcing the breathing rhythm.
|
Guided Mindfulness Audiovisual Intervention
n=77 Participants
Mindfulness intervention delivered
Mindfulness video sessions: The audio component of the mindfulness intervention featured a female narrator guiding participants through mindfulness exercises, focusing on breath awareness and cultivating non-judgmental attention to thoughts and feelings. Ambient tonal sounds, including a harmonic drone with slow timbral changes, played softly in the background to support relaxation. Importantly, no rhythmic audio cues were included to avoid inducing breathing entrainment. This setup emphasized passive, mindful observation rather than active breath control, encouraging participants to observe their bodily sensations and thoughts without judgment.
|
Control
n=72 Participants
Participants in the control condition completed other typical after-school activities while participants in the intervention condition completed one of two breathing interventions: paced breathing (paced), or mindful breathing (mindfulness). Participants in the control condition were given the opportunity to complete the intervention after the study ended.
|
|---|---|---|---|
|
Patient Health Questionnaire 9 (PHQ-9)
|
5.82 units on a scale
Standard Deviation 5.04
|
5.86 units on a scale
Standard Deviation 5.71
|
10.83 units on a scale
Standard Deviation 6.93
|
Adverse Events
Guided Paced Breathing Audiovisual Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Guided Mindfulness Audiovisual Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place