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Completed

NCT Number: NCT05262621

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

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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Key information

Conditions

Cancer Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vietnam National Cancer Institute, Hanoi Oncology Hospital

Hanoi, 134000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive Muscle Relaxation

Other

Practice muscle relaxation for 20 minutes once/a day

Listening to relaxing music once/day

Other

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

Primary outcomes

  1. Change from baseline anxiety at 3 weeks and 6 weeks

    Time frame: ebaseline, T1 after 3 weeks, T2 after 6 weeks

    it will be measured using the short form of the Depression Anxiety Stress Scale (DASS-21). It includes 7 items for anxiety (DASS21-A). A 4-point Likert-type scale ranging from 0 to 3 was designed for each item, and the scores will need to be multiplied by 2 to calculate the final score. Thus, the anxiety score can range from 0 to 42. The higher the score is the more severe anxiety. The score of 0-7 is normal, 8-9 mild, 10-14 moderate, 15-19 severe, +20 extremely severe.

  2. Change from baseline depression at 3 weeks and 6 weeks

    Time frame: baseline, T1 after 3 weeks, T2 after 6 weeks

    it will be measured using the short form of the Depression Anxiety Stress Scale (DASS-21). It includes 7 items for depression (DASS21-D). A 4-point Likert-type scale ranging from 0 to 3 was designed on each item, and the scores will need to be multiplied by 2 to calculate the final score. Thus, the depression score can range from 0 to 42. The higher the score is the more severe depression. The score of 0-9 is normal, 10-13 mild, 14-20 moderate, 21-27 severe, +28 extremely severe.

Secondary outcomes

  1. Change from baseline stress at 3 weeks and 6 weeks

    Time frame: baseline, T1 after 3 weeks, T2 after 6 weeks

    it will be measured using the short form of the Depression Anxiety Stress Scale (DASS-21). It includes 7 items for stress (DASS21-S). A 4-point Likert-type scale ranging from 0 to 3 was designed for each item, and the scores will need to be multiplied by 2 to calculate the final score. Thus, the stress score can range from 0 to 42. The higher the score is the more severe stress. The score of 0-14 is normal, 15-18 mild, 19-25 moderate, 26-33 severe, +34 extremely severe.

  2. Change from baseline coping styles at 3 weeks and 6 weeks

    Time frame: baseline, T1 after 3 weeks, T2 after 6 weeks

    Coping will be measured using Brief COPE. The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.The scale can determine someone's primary coping styles with scores on the following three subscale:

    Problem-Focussed Coping, Emotion-Focussed Coping, Avoidant Coping.A 4-point Likert-type scale ranging from 1 to 4 was designed on each item.

  3. Change from baseline quality of life at 3 weeks and 6 weeks

    Time frame: baseline, T1 after 3 weeks, T2 after 6 weeks

    coping will be measured using FACT-G.It evaluates in functional scales on Social/family well-being (SWB); Emotional well-being (EWB) and Functional well-being (FWB). Each item is scored in one of five categories of 0-4, with 'Not at all', 'A little bit', 'some what', 'Quite a bit' 'Very much'. The higher the score is the better quality of life." The possible range of scores is from 0 to 112.

  4. Change from baseline satisfaction of nursing care at 3 weeks

    Time frame: baseline, T1 after 3 weeks,

    satisfaction of nursing care will be measured using numerical rating scale.(0-10) from 0 = completely dissatisfied with the care to 10 = completely satisfied with the care.

Sponsors and collaborators

Lead sponsor

The Nethersole School of Nursing

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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