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NCT Number: NCT06282887

Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and a Relevant Mediator

The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation.

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Key information

Conditions

Psycho-Oncology Anxiety Disorders Mental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GuangZhou Concord Cancer Center

Guangzhou, Guangdong, 510700, China

Location status: Recruiting

Location contact

Juan Nie, Masters

CONTACT

About this study

To assess the protocol, recruited participants will be randomly allocated into two groups: a control group or a music therapy group. Participants in the control group will receive standard care as usual, and they will be offered music therapy interventions upon their request during subsequent appointments. Participants in the music group will receive standard care and music therapy interventions. All participants will rate their psychological states pre- and post-MRI exams. Their physiological data will be recorded during the examination. After the scanning, they will complete an experience review.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject is diagnosed with cancer;
  • The subject is between 18- 60 years old;
  • The subject understands Mandarin, Cantonese, or English;
  • The subject did not use medication for sedatives, anxiolytics, and/or sleep aids;
  • The subject is awake without cognitive disorders;
  • the subject rates more than 0 on the 0-10 VAS for anxiety;
  • The subject has finished primary school level education.

Exclusion criteria

  • The subject withdraws the MRI scan;
  • The subject needs other intervention(s) to complete the scan;
  • The subject has hearing and/or visual impairments;
  • The subject has a history of a severe somatic psychiatric disease or clinically diagnosed mental disorders.

Treatment and study plan

Music Therapy

Other

The intervention has two parts. The first part is an approximately 15-minute music therapy session to induce relaxation and positive memories attached to the relaxing live music provided by a credentialed music therapist. The second part is music listening during the scanning process.

Primary outcomes

  1. Anxiety

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days

    Self-rating scale (VAS 0-10) to rate patient anxiety, with 0 being no anxiety and 10 being extreme anxious

  2. Symptom distress

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days

    Self-rating scale (VAS 0-10) to rate symptom distress, with 0 being no distress and 10 being extreme distressed.

  3. Relaxation

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 days

    Self-rating scale (VAS 0-10) to rate relaxation, with 0 being unrelaxed and 10 being very relaxed.

Secondary outcomes

  1. Pulse rates

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 day

    The change of pulse rates during MRI scanning

  2. Respiration rate

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

    The change of respiration rate during MRI scanning

  3. Scanning efficiency

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

    Duration of actual scans require, duration of the whole process, and the frequency of pause due to patient in-compliance

  4. Patient satisfaction level

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days

    A 1 to 5 satisfaction scale, with 1 being strongly unsatisfied, 2 being unsatisfied, 3 being somewhere between unsatisfied and satisfied, 4 being quite satisfied. and 5 being strongly satisfied

  5. Patient attention to music (only for the music therapy group)

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 days

    A 1 to 5 self-rating scale, with 1 being fully attended during the whole process, 2 being attended most time during scanning, 3 being attended sometime during scanning, 4 being unattended most time during scanning, and 5 being fully unattended

Study contacts

Contact information is provided by the study sponsor or research team.

Yinglan He

CONTACT

[email protected]

18320739030

Sponsors and collaborators

Lead sponsor

Guangzhou Concord Cancer Center

Other

Registry information

Official study title

The Effects of Music Therapy on Improving Psychological States of Cancer Patients Undergoing MRI Scans and a Relevant Mediator

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Jan 1, 2025

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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