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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
(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.
Agustina
Buenos Aires, Argentina
RECRUITINGchange 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).
Time frame: up to 48 hours
change in prevalent symptoms (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) ESAS-r scale
Time frame: up to 48 hours
change in Anxiety
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.
Time frame: up to 48 hours
change in emotional distress
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.
Time frame: up to 48 hours
change in heart rate
finger oximeter
Time frame: up to 24 hours
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