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Effect of Music Breathing for Promoting Sense of Coherence in Young People: RCT

Primary Purpose

Sense of Coherence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music Breathing
Control condition
Sponsored by
Tung Wah College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sense of Coherence focused on measuring music therapy, Sense of coherence, Mental well-being, Stress, Mindfulness, Randomized controlled trial

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Participants receiving the MB programme

    Participants receiving the control condition

    Arm Description

    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

    Mental health education programme: breathing exercise; stress reduction talk

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    Salivary cortisol
    Salivary cortisol levels (sCort)

    Full Information

    First Posted
    November 30, 2022
    Last Updated
    September 8, 2023
    Sponsor
    Tung Wah College
    Collaborators
    Caritas Institute of Higher Education
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05655234
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tung Wah College
    Collaborators
    Caritas Institute of Higher Education

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sense of Coherence
    Keywords
    music therapy, Sense of coherence, Mental well-being, Stress, Mindfulness, Randomized controlled trial

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    We will conduct randomised controlled trial (RCT) to evaluate the effects of the MB programme
    Masking
    Outcomes Assessor
    Masking Description
    A research team member will be masked when performing data analysis
    Allocation
    Randomized
    Enrollment
    290 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants receiving the MB programme
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Participants receiving the control condition
    Arm Type
    Placebo Comparator
    Arm Description
    Mental health education programme: breathing exercise; stress reduction talk
    Intervention Type
    Behavioral
    Intervention Name(s)
    Music Breathing
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control condition
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Sense of coherence: change from pre-intervention to post-intervention in sense of coherence
    Description
    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.
    Time Frame
    Pre- to post-intervention (10 weeks)
    Secondary Outcome Measure Information:
    Title
    Coping self-efficacy: change from pre-intervention to post-intervention in coping self-efficacy
    Description
    The 26-item Coping Self-Efficacy Scale (CSES) ranges from 0-10. Higher scores indicate greater levels of coping self-efficacy.
    Time Frame
    Pre- to post-intervention (10 weeks)
    Title
    Emotion regulation: change from pre-intervention to post-intervention in emotion regulation
    Description
    The 36-item Difficulties in Emotion Regulation Scale (DERS) ranges from 1 to 5. Higher scores indicate more difficulty in emotion regulation.
    Time Frame
    Pre- to post-intervention (10 weeks)
    Title
    Mindfulness: change from pre-intervention to post-intervention in mindfulness
    Description
    The 15-item Mindful Attention Awareness Scale (MAAS) (Chinese version) ranges from 1-6. Higher scores reflect higher levels of dispositional mindfulness.
    Time Frame
    Pre- to post-intervention (10 weeks)
    Title
    Depression, anxiety and stress: change from pre-intervention to post-intervention in depression, anxiety and stress
    Description
    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.
    Time Frame
    Pre- to post-intervention (10 weeks)
    Title
    Subjective general well-being; change from pre-intervention to post-intervention in subjective general well-being
    Description
    The 24-item BBC Subjective Well-being Scale (BBC-SWB) ranges from 1-5. The higher score indicates better levels of well-being.
    Time Frame
    Pre- to post-intervention (10 weeks)
    Title
    Salivary cortisol
    Description
    Salivary cortisol levels (sCort)
    Time Frame
    post-intervention at week 6
    Other Pre-specified Outcome Measures:
    Title
    Demographic information
    Description
    A self-developed questionnaire will be used to collect demographic information about the participants, including age, gender, educational level, religious beliefs and practices, socioeconomic status and coping behaviour. The latter will be assessed using the Brief Cope Inventory
    Time Frame
    before the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Winnie LS Cheng, PhD
    Phone
    852-91794786
    Email
    wcheng@cihe.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Winnie LS Cheng, PhD
    Phone
    852-91794786
    Email
    winnie.ls.cheng@connect.polyu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Winnie LS Cheng, PhD
    Organizational Affiliation
    Caritas Institute of Higher Education
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The data can be released when requested.

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    Effect of Music Breathing for Promoting Sense of Coherence in Young People: RCT

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