Effects of Receptive Music Therapy Combined With Virtual Reality on Prevailing Symptoms in Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in the guiding symptom
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •they should not present cognitive impairment (measured by Pfeiffer scale [21] > 2 errors)
- •have functional hearing (with or without hearing aids or other devices).
研究组 & 干预措施
RMT+ VR
The patient selects a video with the Oculus Quest headset and music to be played live.
干预措施: RMT+ VR (Other)
Control
No intervention
结局指标
主要结局
change in the guiding symptom
时间窗: 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).
次要结局
- 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)
研究者
Maria Julia Cremona
Sponsor-Investigator
Austral University, Argentina