Effects of Receptive Music Therapy Combined With Virtual Reality on Prevalent Symptoms in Patients With Advanced Cancer

Not Applicable

Recruiting

• Conditions: Music Therapy
• Interventions: Other: RMT+ VR

• Registration Number: NCT05603767
• Lead Sponsor: Austral University, Argentina

Brief Summary

The present research seeks to determine whether a single responsive music therapy intervention combined with virtual reality (RMT+VR) reduces prevalent symptoms and improves their overall well-being in hospitalized adult patients with advanced oncologic disease receiving palliative care. This is a prospective study of a randomized clinical trial with a control group. The main variables are pain, exhaustion, drowsiness, nausea, loss of appetite, dyspnea, depression, anxiety, sleep and well-being as well as heart rate.

Detailed Description

Music therapy has been shown to be effective in hospitalized patients, reducing the level of stress and anxiety, lowering tension, regulating breathing and relieving pain. However, despite the fact that there are many precedents of this type in palliative care, the quality of the evidence is low. The present research seeks to determine whether a single responsive music therapy intervention combined with virtual reality (RMT+VR) reduces prevalent symptoms and improves their overall well-being in hospitalized adult patients with advanced oncologic disease receiving palliative care. This is a prospective study of a randomized clinical trial with a control group. The main variables are pain, exhaustion, drowsiness, nausea, loss of appetite, dyspnea, depression, anxiety, sleep and well-being as well as heart rate. The duration of the study will be 48 hours. After signing the informed consent, patients will be randomized on the first day receiving RMT+VR, or no intervention at all. The variables will be measured on three occasions, before and after each condition, and 24 hours later.

Study Timeline

• Study Start: 2022-09-19
• Status Verified: 2022-10
• Primary Completion: 2022-10-11
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-27
• Last Update Submitted: 2022-10-27
• Study First Posted: 2022-11-03
• Last Update Posted: 2022-11-03
• Study Completion: 2023-10-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• All of them are treated by the Palliative Care Unit of the Austral University Hospital.
• Individuals ≥ 18 years of age with advanced cancer defined from the use of the NECPAL-CCOMS Instrument
• They can be hospitalized in the medical clinic service (AUH) or in the Integral Care Unit (ICUA) within the hospital, and must sign the informed consent after being duly explained by the principal investigator.
• Likewise, they must have a minimum previous ESAS-r of at least 7 points in a symptom,
• they must be able to adopt a posture of at least 45º in bed and a state of alertness and adequate response.

Exclusion Criteria

• they should not present cognitive impairment (measured by Pfeiffer scale [21] > 2 errors)
• have functional hearing (with or without hearing aids or other devices).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RMT+ VR	RMT+ VR	The patient selects a video with the Oculus Quest headset and music to be played live.

Primary Outcome Measures

Name	Time	Method
change in the guiding symptom	up to 48 hours	main symptom of the patient among the 9 prevalent symptoms included in the ESAS-r scale(pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and sleep), on a numerical scale from 0 to 10 (10 = worst possible).

Secondary Outcome Measures

Name	Time	Method
change in emotional distress	up to 48 hours	To measure emotional distress or discomfort, the emotional distress screening questionnaire (DME). The DME gives a total score (0 to 20) formed by the sum of the scores of the answers to the questions referring to the assessment of mood and to the assessment of how the patient is coping with the situation.
change in prevalent symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and sleep)	up to 48 hours	on a numerical scale from 0 to 10 (10 = worst possible) ESAS-r scale
change in Anxiety	up to 48 hours	The State-Trait Anxiety Inventory is a self-report scale with 20 items to assess state anxiety, on a 4-point Likert scale. It has a score ranging from 0 to 60 points. As for the minimum clinically significant change (MCID) for the STAI, it was set at 10 points. Likewise, a cut-off point of 39 or 40 has been suggested to detect clinically significant symptoms.
change in heart rate	up to 24 hours	finger oximeter

Trial Locations

Locations (1)

Agustina; 🇦🇷 Buenos Aires, Argentina