Feasibility and Efficacy of Hypnosis and Music on Pain, Anxiety and Well-being in End-of-life Palliative Care at Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Composite pain, anxiety, and unwellness score
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the efficacy of a personalized multimodal intervention program (MuzHyp) including hypnosis, music or their combination to improve palliative care at home.
The main objective is to evaluate if the intervention program will significantly reduce participants' composite score of pain, anxiety, and unwellness as evaluated by the Edmonton symptom assessment scale (ESAS) immediately after the intervention, and whether this improvement will be significantly greater than that of control sessions.
详细描述
Context :
Quality of life at home in end-of-life palliative care is an ideal that is often difficult to achieve. Side effects of medications and limited access to resources and services can affect the control of pain, anxiety and well-being. Research shows that musical interventions and the use of medical hypnosis can help reduce pain and anxiety, and thus improve patients' psychological well-being in many clinical settings. In view of this, we have developed an intervention program combining medical hypnosis and music (Bissonnette et al., 2022; https://www.frontiersin.org/articles/10.3389/fpain.2022.926584/full).
Objectives and study design :
The main objective of this randomized control trial is to evaluate the efficacy of a personalized multimodal intervention program including hypnosis, music or their combination on composite score of pain, anxiety and unwellness as evaluated with the ESAS.
The secondary objectives are to assess :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •End-of-life palliative care at home
- •Between 30% and 79% on the Karnofsky Performance Index
- •With adequate communication skills to complete the steps of the research
- •With satisfactory or corrected hearing, as recommended by the caregiver.
- •Severe neurocognitive or psychotic disorders
排除标准
- •Severe neurocognitive or psychotic disorders
结局指标
主要结局
Changes in Composite pain, anxiety, and unwellness score
时间窗: The posttest was administered 25 minutes after the pretest.
Change in composite outcome score for pre-test to post-test for the experimental sessions compared with change in the control group. The composite score will be obtained by summing the pain (0-10), anxiety (0-10) and unwellness scores (0-10) from the Edmonton Symptom Assessment Scale. (ESAS)
次要结局
- Changes in Nausea levels(The posttest was administered 25 minutes after the pretest.)
- Changes in Sleepiness levels(The posttest was administered 25 minutes after the pretest.)
- Feasibility of the study(Through study completion, an average of 1 year.)
- Changes in Anxiety levels(The posttest was administered 25 minutes after the pretest.)
- Changes in Appetite(The posttest was administered 25 minutes after the pretest.)
- Preference of the intervention modality(At baseline)
- Changes in Pain levels(The posttest was administered 25 minutes after the pretest.)
- Changes in Unwellness levels(The posttest was administered 25 minutes after the pretest.)
- Changes in Fatigue levels(The posttest was administered 25 minutes after the pretest.)
- Changes in Distress(The posttest was administered 25 minutes after the pretest.)
- Experiential dimensions(1 week)
- Changes in Depression levels(The posttest was administered 25 minutes after the pretest.)
研究者
Josiane Bissonnette
Professor
Laval University