Clinical trial NCT05603767: Effects of Receptive Music Therapy Combined With Virtual Reality on Prevalent Symptoms in Patients With Advanced Cancer
Official title: Effects of Receptive Music Therapy Combined With Virtual Reality on Prevailing Symptoms in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Music Therapy
Keywords: Virtual Reality
Paliative Care
Anxiety
Emotional distress
advanced cancer
prevalent symptoms
Lead sponsor: Austral University, Argentina
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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).

Primary outcomes:
measure: change in the guiding symptom
timeFrame: up to 48 hours
Secondary outcomes:
measure: change in prevalent symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and sleep)
timeFrame: up to 48 hours
measure: change in Anxiety
timeFrame: up to 48 hours
measure: change in emotional distress
timeFrame: up to 48 hours
measure: change in heart rate
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Agustina
Study officials:
References: