The Effectiveness of Progressive Muscle Relaxation Technique in Reducing Cancer-related Pain Among Palliative Care Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 主要终点
- Cancer-related pain
研究概览
简要总结
This randomized controlled trial was designed to evaluate the effectiveness of the Progressive Muscle Relaxation (PMR) technique in reducing Cancer-related Pain (CRP) in patients receiving palliative care in Jordan.
The main hypothesis (H0) of this trial is that cancer patients receiving palliative care do not report a decrease in pain intensity levels and an improve in pain interferences with life activities as a result of participating in PMR technique to a significant extent compared to patients who do not participate. The sub-hypothesis (H1) of this trial is that cancer patients receiving palliative care report a decrease in pain intensity levels and an improve in pain interferences with life activities as a result of participating in PMR technique to a significant extent compared to patients who do not participate.
详细描述
-
Methods
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Design:
This study was designed as an assessor-blinded, prospective, two parallel groups, randomized, controlled trial. 2. Participants and setting:
Participants were recruited from palliative care outpatient clinics at King Hussein Cancer Center in Amman, Jordan.
The sample size was calculated using statistical software package G* Power 3.0.10. Based on α = 0.05, a power of 80%, and a medium effect size (Cohen's d = 0.50), the minimum required sample for each group was 64 patients. To be conservative and avoid the negative impact of attrition, the sample was increased to 150 patients for both groups; hence 75 participants were required per group. 3. Randomization:
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
- Single (Outcomes Assessor)
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
- •age of 18 years and older
- •diagnosed with cancer.
- •reported complaints of pain ≥1 on a 0-10 Numerical Rating Scale (NRS) in the 24 hours before recruitment.
- •were treated with non-opioid or weak opioid analgesic.
- •had a Karnofsky Performance Scale Index ≥
- •had regular access to a telephone.
排除标准
- •a diagnosis of psychiatric illness, central nervous system tumors and musculoskeletal disorders (because these conditions may limit the effectiveness of PMR technique).
- •using any type of complementary therapy during the trial period.
- •Patients who had no pain and were treated with strong opioid analgesics.
结局指标
主要结局
Cancer-related pain
时间窗: The BPI assessment was collected at 1-month follow-up (T2)
Brief Pain Inventory (BPI) was used to assess cancer-related pain. The BPI consists of two subscales: (1) pain intensity, and (2) pain interferences with life activities. The pain intensity is evaluated at 4 different times: (1) the worst pain in the last 24 hours, (2) the least pain in the last 24 hours, (3) pain on average, and (4) pain right now. By asking patients to rate their pain on the 0 (no pain) to 10 (pain as bad as you can imagine) rating scale, the average of these 4 items is the person's pain intensity. The second subscale, pain interference, consists of 7 items that evaluate the extent to which pain interferes with general activity, walking, mood, relations with others, working, sleep, and enjoyment of life. Each item is rated on the 0 (does not interfere) to 10 (completely interferes).
次要结局
未报告次要终点
研究者
Huda Anshasi
Assistant Professor
University of Jordan