Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05655234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-13
First Post:
2022-11-30
Brief Title:
Effect of Music Breathing for Promoting Sense of Coherence in Young People RCT
Sponsor:
Tung Wah College
Organization:
Tung Wah College
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 ie 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
The main questions it aims to answer are
What is the effect of a MB programme on personal resources ie 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 ie 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 peoples 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 11 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 GPower 3194 version 2019 for a multivariate analysis of variance MANOVA according to the effect size Cohens d between 043 and 059 of anxiety in previous study on group music-guided imagery Torres et al 2018 When converting to a repeated measure Cohens f the effect size is considered moderate f 025 with a type I error rate of 5 2-sided and assuming a correlation of 05 between repeated measures To achieve 90 power to measure outcome three times in two groups 232 subjects n116 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 ie 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
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 11 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 GPower 3194 version 2019 for a multivariate analysis of variance MANOVA according to the effect size Cohens d between 043 and 059 of anxiety in previous study on group music-guided imagery Torres et al 2018 When converting to a repeated measure Cohens f the effect size is considered moderate f 025 with a type I error rate of 5 2-sided and assuming a correlation of 05 between repeated measures To achieve 90 power to measure outcome three times in two groups 232 subjects n116 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None