NCT05655234

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

November 30, 2022

Last Update Submit

September 8, 2023

Conditions

Keywords

music therapySense of coherenceMental well-beingStressMindfulnessRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre- to post-intervention (10 weeks)

Secondary Outcomes (6)

  • Coping self-efficacy: change from pre-intervention to post-intervention in coping self-efficacy

    Pre- to post-intervention (10 weeks)

  • Emotion regulation: change from pre-intervention to post-intervention in emotion regulation

    Pre- to post-intervention (10 weeks)

  • Mindfulness: change from pre-intervention to post-intervention in mindfulness

    Pre- to post-intervention (10 weeks)

  • Depression, anxiety and stress: change from pre-intervention to post-intervention in depression, anxiety and stress

    Pre- to post-intervention (10 weeks)

  • Subjective general well-being; change from pre-intervention to post-intervention in subjective general well-being

    Pre- to post-intervention (10 weeks)

  • +1 more secondary outcomes

Other Outcomes (1)

  • Demographic information

    before the intervention

Study Arms (2)

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

Behavioral: Music Breathing

Participants receiving the control condition

PLACEBO COMPARATOR

Mental health education programme: breathing exercise; stress reduction talk

Behavioral: Control condition

Interventions

Music BreathingBEHAVIORAL

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.

Participants receiving the MB programme

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.

Participants receiving the control condition

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Winnie LS Cheng, PhD

    Caritas Institute of Higher Education

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Winnie LS Cheng, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A research team member will be masked when performing data analysis
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: We will conduct randomised controlled trial (RCT) to evaluate the effects of the MB programme
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Practice

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 19, 2022

Study Start

September 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

The data can be released when requested.