Health TrialsbyHealthPanel

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

ConditionPsycho-Oncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGuangzhou Concord Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Music therapy

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Music Therapy GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Anxiety

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

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
2

Symptom distress

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

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
3

Relaxation

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

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

Secondary outcomes

1

Pulse rates

The change of pulse rates during MRI scanning

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
2

Respiration rate

The change of respiration rate during MRI scanning

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
3

Scanning efficiency

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

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
4

Patient satisfaction level

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou Concord Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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