Clinical trial NCT05262621: Effects of Music Intervention Combined With Progressive Muscle Relaxation in Cancer Patients
Official title: Effects of Music Intervention Combined With Progressive Muscle Relaxation on Anxiety, Depression and Quality of Life in Breast and Gynaecological Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: music intervention
progressive muscle relaxation
anxiety
depression
quality of life
chemotherapy
beast cancer
gynaecology cancer
Lead sponsor: The Nethersole School of Nursing
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline anxiety at 3 weeks and 6 weeks
timeFrame: ebaseline, T1 after 3 weeks, T2 after 6 weeks
measure: Change from baseline depression at 3 weeks and 6 weeks
timeFrame: baseline, T1 after 3 weeks, T2 after 6 weeks
Secondary outcomes:
measure: Change from baseline stress at 3 weeks and 6 weeks
timeFrame: baseline, T1 after 3 weeks, T2 after 6 weeks
measure: Change from baseline coping styles at 3 weeks and 6 weeks
timeFrame: baseline, T1 after 3 weeks, T2 after 6 weeks
measure: Change from baseline quality of life at 3 weeks and 6 weeks
timeFrame: baseline, T1 after 3 weeks, T2 after 6 weeks
measure: Change from baseline satisfaction of nursing care at 3 weeks
timeFrame: baseline, T1 after 3 weeks,
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam National Cancer Institute, Hanoi Oncology Hospital
Study officials:
affiliation: The Nethersole School of Nursing, The Chinese University of Hong Kong
name: Khanh Thi Nguyen, master
role: PRINCIPAL_INVESTIGATOR
References: