Effects of Music Intervention Combined With Progressive Muscle Relaxation in Cancer Patients

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-08

Study Completion Date

2022-08-10

Brief Summary

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Study design A 2-arm, assessor-blinded randomised controlled trial will be conducted. The design will follow the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT)

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Detailed Description

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Aim: To assess the effect of MCP on anxiety, depression and QoL of BGC patients receiving chemotherapy.

Objectives

* To assess the effect of MCP on the anxiety of BGC patients receiving chemotherapy.
* To assess the effect of MCP on depression of BGC patients receiving chemotherapy.
* To assess the effect of MCP on QoL and patients' satisfaction of BGC patients receiving chemotherapy.
* To determine whether stress level, coping and coping styles mediate the intervention effect on anxiety, depression and QoL.

Hypothesis

* The participants receiving MCP will have a significantly lower level of anxiety compared to the control group.
* The participants receiving MCP will have a significantly lower level of depression compared to the control group.
* The participants receiving MCP will have significantly higher QoL scores and levels of satisfaction with care service compared to the control group.
* Stress level, coping will mediate the intervention on target outcomes.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

The research assistants who assess outcome data, data entry and analysis will be blinded to avoid the risk of assessor bias. The assistants will not participate in any other stage of implementing the program.

Study Groups

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Music intervention combined with progressive muscle relaxation

Music intervention combined with progressive muscle relaxation.

Group Type EXPERIMENTAL

progressive muscle relaxation

Intervention Type OTHER

Practice muscle relaxation for 20 minutes once/a day

Listening to relaxing music once/day

Intervention Type OTHER

Right after practising progressive muscle relaxation, the participants will listen to relaxing music for 20 minutes

Control group

no music therapy will be done.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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progressive muscle relaxation

Practice muscle relaxation for 20 minutes once/a day

Intervention Type OTHER

Listening to relaxing music once/day

Right after practising progressive muscle relaxation, the participants will listen to relaxing music for 20 minutes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women with breast or gynaecological cancer are 18 years of age or older, and are independent legally to sign the consent form.
* Living with family and having an adult family member agree to participate in the meeting part of the program.
* Had been informed the cancer diagnosis
* Have Karnofsky score (Mor et al., 1984) ≥ 80 ( to be able to self-practice MCP)
* Can communicate, read and write in Vietnamese
* Have a device such as a smartphone, MP3 to keep the audio file (to self-practice MCP at home)
* Consent to join the study

Exclusion Criteria

* The patients cannot understand the study procedures
* Have mental health illness, deafness, blindness
* Have not been aware of their cancer or the purpose of chemotherapy
* Be participating in other studies related to psychological issues
* Be receiving anxiety or depression treatment.
* Be participating in relaxation therapy such as yoga, meditation, mindfulness, PMR...
* Have a potential treatment (eg. surgery) or personal plans that will prevent them from practising daily during the 6 weeks of the intervention.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No