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

T

The Nethersole School of Nursing

Status

Completed

Conditions

Cancer

Treatments

Other: progressive muscle relaxation
Other: Listening to relaxing music once/day

Study type

Interventional

Funder types

Other

Identifiers

NCT05262621
TheNethersole

Details and patient eligibility

About

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)

Full 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.

Enrollment

84 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

Music intervention combined with progressive muscle relaxation
Experimental group
Description:
Music intervention combined with progressive muscle relaxation.
Treatment:
Other: progressive muscle relaxation
Other: Listening to relaxing music once/day
Control group
No Intervention group
Description:
no music therapy will be done.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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