Sense of CoherenceNCT05655234
Effect of Music Breathing for Promoting Sense of Coherence in Young People: RCT
A study testing Music Breathing in people with Sense of Coherence, run by Tung Wah College.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sense of Coherence
- What is being tested?
- Music Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- moderate stress level measured with perceived stress scale (PSS-10) >or =14-26
- a liking for music
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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:
Read more
- 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
Read the 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.
- Conditions
- Sense of Coherence
- Being tested
- Music Breathing, Control condition
- Keywords
- music therapy, Sense of coherence, Mental well-being, Stress, Mindfulness, Randomized controlled trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music BreathingBehavioural
The MB programme consists of four stages: 1. Silent breathing for grounding (SB), 2. Music breathing for grounding (MBG), 3. Music breathing for modulation (MM), 4. Music breathing for working (MW).
After completing the silent breathing and music breathing practices, the participants will draw pictures of their body images of breathing space and centre. The form of the imagined breathing space expressed in the drawing and the meaning and content of the experience will be explored through a process facilitated by the therapist. The therapist's understanding of the participants' difficulties and progress will guide the next step, particularly the selection of music for the next sessions. The whole session takes about 2 hours. Weekly home practice is advised.
Control conditionBehavioural
The control condition consists of 30-min mental health education programme with topics on stress management, music playing, and breathing exercise provided in the first and 6th weeks. A take-home kit which consists of the fact sheet information of the health talk and the video link of the breathing exercise and musical pieces will be provided to the participants after the first meeting. They are instructed to practice the breathing exercise and listening to the musical pieces at home.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving the MB programme | Experimental | Participants receiving the MB programme:
meditative breathing; breathing while listening to music; drawing of a mental image while breathing; and processing and sharing of the experience. home practice Receives: Behavioral: Music Breathing |
| Participants receiving the control condition | Placebo comparator | Mental health education programme:
breathing exercise; stress reduction talk Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sense of coherence: change from pre-intervention to post-intervention in sense of coherence
The 13-item Chinese version of the Sense of Coherence Scale (C-SOC-13) ranges from 1 to 7. Higher scores indicate greater levels of sense of coherence.
Measured: Pre- to post-intervention (10 weeks)
Secondary outcomes (6)
Coping self-efficacy: change from pre-intervention to post-intervention in coping self-efficacy
The 26-item Coping Self-Efficacy Scale (CSES) ranges from 0-10. Higher scores indicate greater levels of coping self-efficacy.
Measured: Pre- to post-intervention (10 weeks)
Emotion regulation: change from pre-intervention to post-intervention in emotion regulation
The 36-item Difficulties in Emotion Regulation Scale (DERS) ranges from 1 to 5. Higher scores indicate more difficulty in emotion regulation.
Measured: Pre- to post-intervention (10 weeks)
Mindfulness: change from pre-intervention to post-intervention in mindfulness
The 15-item Mindful Attention Awareness Scale (MAAS) (Chinese version) ranges from 1-6. Higher scores reflect higher levels of dispositional mindfulness.
Measured: Pre- to post-intervention (10 weeks)
Depression, anxiety and stress: change from pre-intervention to post-intervention in depression, anxiety and stress
The 21-item Depression Anxiety Stress Scales (DASS-21) (Chinese version) range from 0-3.
Higher scores reflect higher levels of depression, anxiety, and stress.
Measured: Pre- to post-intervention (10 weeks)
Subjective general well-being; change from pre-intervention to post-intervention in subjective general well-being
The 24-item BBC Subjective Well-being Scale (BBC-SWB) ranges from 1-5. The higher score indicates better levels of well-being.
Measured: Pre- to post-intervention (10 weeks)
Salivary cortisol
Salivary cortisol levels (sCort)
Measured: post-intervention at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study startSep 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sense of CoherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct randomised controlled trial (RCT) to evaluate the effects of the MB programme
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Collaborators
- Caritas Institute of Higher Education
- Responsible party
- Principal investigator, Winnie CHENG Lai Sheung, Caritas Institute of Higher Education
- Investigators
- Winnie LS Cheng, PhD, Principal investigator, Caritas Institute of Higher Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655234
- Sponsor's protocol ID
- UGC/FDS17(11)/H03/22
- Status last verified
- Sep 2023
- First submitted
- 30 Nov 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data can be released when requested.
Publications
Cheng WL, Tang AC, Tsang MC, Wong LL, Korlin D. Effect of music breathing, a program based on mindful breathing and music listening therapy for promoting sense of coherence in young people: study protocol for a randomized controlled trial. Trials. 2023 Oct 12;24(1):662. doi: 10.1186/s13063-023-07645-x.
PubMed 37828487
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05655234
- Acronym / sponsor ID
- UGC/FDS17(11)/H03/22
- Conditions
- Sense of Coherence
- Keywords
- music therapy, Sense of coherence, Mental well-being, Stress, Mindfulness, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Collaborators
- Caritas Institute of Higher Education
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will conduct randomised controlled trial (RCT) to evaluate the effects of the MB programme
| Arm | Type | Receives |
|---|---|---|
| Participants receiving the MB programme | Experimental | Behavioral: Music BreathingParticipants receiving the MB programme: meditative breathing; breathing while listening to music; drawing of a mental image while breathing; and processing and sharing of the experience. home practice |
| Participants receiving the control condition | Placebo comparator | Behavioral: Control conditionMental health education programme: breathing exercise; stress reduction talk |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- moderate stress level measured with perceived stress scale (PSS-10) >or =14-26
- a liking for music
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music BreathingThe MB programme consists of four stages: 1. Silent breathing for grounding (SB), 2. Music breathing for grounding (MBG), 3. Music breathing for modulation (MM), 4. Music breathing for working (MW). After completing the silent breathing and music breathing practices, the participants will draw pictures of their body images of breathing space and centre. The form of the imagined breathing space expressed in the drawing and the meaning and content of the experience will be explored through a process facilitated by the therapist. The therapist's understanding of the participants' difficulties and progress will guide the next step, particularly the selection of music for the next sessions. The whole session takes about 2 hours. Weekly home practice is advised. | Behavioural | Participants receiving the MB programme |
| Control conditionThe control condition consists of 30-min mental health education programme with topics on stress management, music playing, and breathing exercise provided in the first and 6th weeks. A take-home kit which consists of the fact sheet information of the health talk and the video link of the breathing exercise and musical pieces will be provided to the participants after the first meeting. They are instructed to practice the breathing exercise and listening to the musical pieces at home. | Behavioural | Participants receiving the control condition |
Primary outcome
Sense of coherence: change from pre-intervention to post-intervention in sense of coherence
Time frame: Pre- to post-intervention (10 weeks)
The 13-item Chinese version of the Sense of Coherence Scale (C-SOC-13) ranges from 1 to 7. Higher scores indicate greater levels of sense of coherence.
6 secondary outcomes
Coping self-efficacy: change from pre-intervention to post-intervention in coping self-efficacy
Time frame: Pre- to post-intervention (10 weeks)
Emotion regulation: change from pre-intervention to post-intervention in emotion regulation
Time frame: Pre- to post-intervention (10 weeks)
Mindfulness: change from pre-intervention to post-intervention in mindfulness
Time frame: Pre- to post-intervention (10 weeks)
Depression, anxiety and stress: change from pre-intervention to post-intervention in depression, anxiety and stress
Time frame: Pre- to post-intervention (10 weeks)
Subjective general well-being; change from pre-intervention to post-intervention in subjective general well-being
Time frame: Pre- to post-intervention (10 weeks)
Salivary cortisol
Time frame: post-intervention at week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 37828487Cheng WL, Tang AC, Tsang MC, Wong LL, Korlin D. Effect of music breathing, a program based on mindful breathing and music listening therapy for promoting sense of coherence in young people: study protocol for a randomized controlled trial. Trials. 2023 Oct 12;24(1):662. doi: 10.1186/s13063-023-07645-x.
- Individual participant dataSharing planned: No. The data can be released when requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winnie LS Cheng, PhD principal investigator
Caritas Institute of Higher Education
Questions about this trial
What is this clinical trial studying?
A study testing Music Breathing in people with Sense of Coherence, run by Tung Wah College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Winnie LS Cheng, PhD (852-91794786, wcheng@cihe.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sense of coherence: change from pre-intervention to post-intervention in sense of coherence (time frame: Pre- to post-intervention (10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.