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

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

NCT ID: NCT05603767

Condition: Music Therapy

Conditions: Keywords:
Virtual Reality
Paliative Care
Anxiety
Emotional distress
advanced cancer
prevalent symptoms

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: (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).

Primary purpose: Treatment

Masking: Single (Care Provider)

Masking description: 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.

Intervention:

Intervention type: Other
Intervention name: RMT+ VR
Description: (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.
Arm group label: RMT+ VR

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.

Criteria for eligibility:
Criteria:
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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Agustina

Address:
City: Buenos Aires
Zip: 1846
Country: Argentina

Status: Recruiting

Contact:
Last name: agustina iturri

Phone: 01158540318
Email: agustina.iturri@gmail.com

Start date: September 19, 2022

Completion date: October 11, 2023

Lead sponsor:
Agency: Austral University, Argentina
Agency class: Other

Source: Austral University, Argentina

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05603767