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

NCT05603767 | Unknown DMC

• 1 other identifier: P21-069
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Music Therapy

Keywords

Virtual Reality; Paliative Care; Anxiety; Emotional distress; advanced cancer; prevalent symptoms

Outcome Measures

Primary Outcomes (1)

• change in the guiding symptom

  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).

  up to 48 hours

Secondary Outcomes (4)

• change in prevalent symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and sleep)

  up to 48 hours

• change in Anxiety

  up to 48 hours

• change in emotional distress

  up to 48 hours

• change in heart rate

  up to 24 hours

Study Arms (2)

RMT+ VR

EXPERIMENTAL

The patient selects a video with the Oculus Quest headset and music to be played live.

Other: RMT+ VR

Control

NO INTERVENTION

No intervention

Interventions

RMT+ VR OTHER

(RMT+ VR). The responsive music therapy session combined with virtual reality involves four stages: a) Background settings; b) VR video and music selection; c) Listening experience and VR; and e) Return to alert status. The therapist will help the patient to select the video to be used for the experience. Utilizing the application created by the research team, the patient will be provided with four possible scenarios. As for the music, patients are asked to choose music that relaxes them the most. Chosen music can be instrumental music (guitar, electric piano or violin) or sung music with harmonic accompaniment (piano or guitar). In both cases the music will be played live.

RMT+ VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Austral University, Argentina: lead

Study Sites (1)

Agustina

Buenos Aires, 1846, Argentina

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Patients who agree to participate will be randomized through the "randomlists" web page to the two study groups. The following day the study collaborators will be in charge of taking the preliminary measurements. Afterwards the patient who has been assigned to RMT + VR will receive the session conducted by the principal investigator The control group will receive no intervention and will continue with their usual care. Between 1-2 hours later, both groups will be visited by the collaborators for subsequent measurements. Which will be recorded again by the collaborators the following 24 hours. In no case will the collaborators know whether the patient received the RMT+ VR intervention or was assigned to the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: (RMT+ VR) a) Background settings; b) VR video and music selection; c) Listening experience and VR; and e) Return to alert status (Figure 2).60 patients will be included. 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 \[20\]. 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 (1) a minimum previous ESAS-r of at least 7 points in a symptom, (2) they must be able to adopt a posture of at least 45º in bed and a state of alertness and adequate response, (3) they should not present cognitive impairment (measured by Pfeiffer scale \[21\] \> 2 errors) and (4) have functional hearing (with or without hearing aids or other devices).

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: November 3, 2022
• Study Start: September 19, 2022
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)