Clinical trial NCT05655234: Effect of Music Breathing for Promoting Sense of Coherence in Young People: RCT
Official title: Effect of Music Breathing, a Programme Based on Mindful Breathing and Music Therapy for Promoting Sense of Coherence in Young People: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sense of Coherence
Keywords: music therapy
Sense of coherence
Mental well-being
Stress
Mindfulness
Randomized controlled trial
Lead sponsor: Tung Wah College
Sponsor class: OTHER
Collaborators: name: Caritas Institute of Higher Education
First posted: 2022-12-19
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct randomised controlled trial (RCT) to evaluate the effects of the MB programme
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this experimental study is to test the effects of Music Breathing (MB) in promoting a sense of coherence among young people.

The main questions it aims to answer are:

* What is the effect of a MB programme on personal resources (i.e., SOC, coping self-efficacy, emotion regulation and mindfulness) compared with the control condition in young people?
* What is the effect of a MB programme on stress reduction (i.e., depression, anxiety and stress, and salivary cortisol levels) compared with the control condition in young people? • • What is the effect of a MB programme on mental well-being compared with the control condition in young people?
* What is the relationship between SOC, coping self-efficacy, emotion regulation and mindfulness?

Participants will receive a MB programme in 6 weekly sessions and weekly home practice. The programme includes:

* meditative breathing;
* breathing with music listening;
* drawing a mental image of the breathing practice; and
* sharing and processing of the experience

Detailed description: The proposed study will evaluate the effect of the Music Breathing (MB) programme on young people's sense of coherence in promoting coping with stress.

In the proposed randomised controlled trial, a sample of 290 young people (aged 18-30) will be recruited and allocated randomly into either the experimental or placebo control group. Participants in the experimental group will participate in a 6-week MB programme that will include music therapy and mindful breathing guided by a certified music therapist.

The following objectives are proposed:

* To examine the effect of a MB programme on promoting personal resources in young people;
* To examine the effect of a MB programme on reducing stress-related symptoms in young people; and
* To examine the effect of a MB programme on promoting mental well-being in young people.

This is a two-arm, parallel randomised controlled trial (RCT). Randomisation involving computer-generated two-digit random numbers (even and odd) (Excel 2007, Microsoft, Redmond, WA, USA) will be used to allocate participants in sequence to either the intervention group or control group in a 1:1 ratio after they have provided consent to participate. The allocation will be blinded to the participants and the data analyst. The random allocation will be conducted by a research assistant who will not be involved in the intervention and data analysis. Participants in the experimental arm will receive a 6-week MB programme. Participants in the control arm will placebo control programme and will be blinded to the study details. Data will be collected from both groups at three time points: before-intervention (T0), after-intervention (week 6; T1) and 1-month follow-up (week 10; T2), except the salivary cortisol levels which will be assessed at T0 and T1.

The participants will be recruited from universities and district centres through emails, social media, leaflets and posters. The estimated sample size has been calculated using the statistical package G\*Power 3.1.9.4 (version 2019) for a multivariate analysis of variance (MANOVA) according to the effect size (Cohen's d) (between 0.43 and 0.59) of anxiety in previous study on group music-guided imagery (Torres et al., 2018). When converting to a repeated measure (Cohen's f), the effect size is considered moderate (f = 0.25), with a type I error rate of 5% (2-sided) and assuming a correlation of 0.5 between repeated measures. To achieve 90% power to measure outcome three times in two groups, 232 subjects (n=116 per group) will be required (Cohen, 1988). Assuming a 20% attrition rate (Porter et al., 2012), the trial will require at least 145 participants starting in each arm.

To ensure treatment fidelity, the certified music therapist will have at least 25 hours of MB programme training; the implementation of the intervention will be supervised by Dag Körlin, the Co-I. The group sessions will be audio-taped with the consent of the participants, and the recordings will be given to the supervisor for quality monitoring. Written session reports will be provided and regular meetings via Zoom (i.e., three supervisions in the first group, and then two supervisions in the subsequent groups) will be arranged for maintaining the quality of the intervention. The research team will discuss any issues that may arise regarding the study protocol to ensure the quality and consistency of study intervention via regular face-to-face or online meetings.

Ethical clearance has been obtained prior to the study from the study institution. Consent will be obtained and anonymity ensured to protect privacy. Participants will receive study information and have autonomy to withdraw from the study at any time.

Eligibility criteria: Inclusion Criteria:

* moderate stress level measured with perceived stress scale (PSS-10) \>or =14-26
* a liking for music

Exclusion Criteria:

* diagnosed with an acute mental problem;
* participants under the influence of drugs that affect the nervous system;
* having previous experience with imagery evoked by music and meditations where music is played.

Primary outcomes:
measure: Sense of coherence: change from pre-intervention to post-intervention in sense of coherence
timeFrame: Pre- to post-intervention (10 weeks)
Secondary outcomes:
measure: Coping self-efficacy: change from pre-intervention to post-intervention in coping self-efficacy
timeFrame: Pre- to post-intervention (10 weeks)
measure: Emotion regulation: change from pre-intervention to post-intervention in emotion regulation
timeFrame: Pre- to post-intervention (10 weeks)
measure: Mindfulness: change from pre-intervention to post-intervention in mindfulness
timeFrame: Pre- to post-intervention (10 weeks)
measure: Depression, anxiety and stress: change from pre-intervention to post-intervention in depression, anxiety and stress
timeFrame: Pre- to post-intervention (10 weeks)
measure: Subjective general well-being; change from pre-intervention to post-intervention in subjective general well-being
timeFrame: Pre- to post-intervention (10 weeks)
measure: Salivary cortisol
timeFrame: post-intervention at week 6
Other outcomes:
measure: Demographic information
timeFrame: before the intervention
Locations:
Study officials:
affiliation: Caritas Institute of Higher Education
name: Winnie LS Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: