Music Breathing for Caregivers of Children Newly Diagnosed With Cancer

NCT ID: NCT06052904

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-03

Study Completion Date

2025-04-02

Brief Summary

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This proposed pilot randomised controlled trial aims to examine the effect of mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress and caregiver strain, and improving the coping and quality of life of parental caregivers of children newly diagnosed with cancer.

Detailed Description

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Parents of children with cancer experience considerable stress and distress from the time of their child's life-threatening diagnosis. Music therapy, for example, music breathing therapy, has been increasingly used as a nonpharmacological care strategy in the healthcare field. Music breathing therapy is an adaptation of the Bonny Method of Guided Imagery and Music. It has demonstrated promising potential for enhancing resilience and alleviating psychological distress among diverse populations, including women with complex post-traumatic stress disorder, individuals with work-related stress and caregivers of dementia patients. However, it is unclear whether this is a feasible and acceptable approach to enhance resilience, reduce psychological distress, and improve the quality of life of Chinese caregivers of children newly diagnosed with cancer.

Aims:

* To assess the effects of a mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, and improving coping and quality of life of parental caregivers of children newly diagnosed with cancer
* To determine the feasibility (in terms of recruitment rates, dropout rates, engagement rates, randomization process, and intervention delivery mode), and acceptability of the intervention.

Hypotheses:

It is hypothesized that compared with caregivers who receive usual care, those who receive the mHealth-delivered music breathing therapy will report higher levels of resilience (primary outcome), lower levels of psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, better coping and quality of life at the 2-month (immediately after intervention) and 6-month follow-ups.

Conditions

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Oncology Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Home-based music breathing therapy comprising eight 1-hour weekly sessions for 2 months delivered through Zoom, an online video conferencing platform, by a qualified music therapist.

Group Type EXPERIMENTAL

mHealth-delivered music breathing therapy

Intervention Type BEHAVIORAL

Parental caregivers in the intervention group will receive individual home-based music breathing therapy comprising eight 1-hour weekly sessions for 2 months delivered through Zoom, by a qualified music therapist based on a standardized and validated music breathing instruction manual. The music breathing therapy comprises four breathing phases, namely "Discovery Breathing", "Triangular Breathing", "Silent Breathing", and "Music Breathing". In each session, participants will practice breathing for approximately 20-25 minutes in silence or with music in a sitting position. Thereafter, the participants will be instructed to create a Mandala drawing to visualize the effects of breathing on their mental body image, emotions, and thoughts. Each session will end with a debriefing session, which will serve to verbally integrate and reflect the participants' experiences and mental states.

Control group

Eight weekly online educational modules on medical information and advice about caring for a child who has been newly diagnosed with cancer via email for 2 months.

Group Type ACTIVE_COMPARATOR

Online educational modules

Intervention Type BEHAVIORAL

Participants in the control group will receive eight weekly online educational modules via email for 2 months. The content of the online educational modules will include medical information and advice about caring for a child who has been newly diagnosed with cancer.

Interventions

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mHealth-delivered music breathing therapy

Parental caregivers in the intervention group will receive individual home-based music breathing therapy comprising eight 1-hour weekly sessions for 2 months delivered through Zoom, by a qualified music therapist based on a standardized and validated music breathing instruction manual. The music breathing therapy comprises four breathing phases, namely "Discovery Breathing", "Triangular Breathing", "Silent Breathing", and "Music Breathing". In each session, participants will practice breathing for approximately 20-25 minutes in silence or with music in a sitting position. Thereafter, the participants will be instructed to create a Mandala drawing to visualize the effects of breathing on their mental body image, emotions, and thoughts. Each session will end with a debriefing session, which will serve to verbally integrate and reflect the participants' experiences and mental states.

Intervention Type BEHAVIORAL

Online educational modules

Participants in the control group will receive eight weekly online educational modules via email for 2 months. The content of the online educational modules will include medical information and advice about caring for a child who has been newly diagnosed with cancer.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Parental caregivers (the primary caregiver; either mother or father) who

* has a child (aged under 19 years) who has been diagnosed with cancer at least 2 months but not more than 12 months prior.
* can read and communicate in Chinese (Cantonese or Mandarin)
* has Internet access through any mobile device (e.g., a cell phone, tablet or laptop with camera and microphone features).
* is willing to download and use Zoom as the intervention delivery platform.

Exclusion Criteria

* has a child who has been diagnosed with cancer and has major comorbid conditions and/or who is receiving end-of-life care.
* is caring for more than one child with a chronic or critical illness or caring for another family member with a chronic illness.
* is currently participating in any interventions or additional counselling services.
* has a diagnosed mental illness, cognitive impairment or learning problem, and/or is taking regular psychotropic medications
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Cheung Tan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ankie Tan Cheung

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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PAED-2022-024

Identifier Type: -

Identifier Source: org_study_id

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