Benson Relaxation Technique Effectiveness on Pain and Quality of Life Post Reconstructive Mammoplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Assessment of pain severity
研究概览
简要总结
The purpose of this study is to evaluate effectiveness of benson relaxation technique on pain and quality of life post mammoplasty.
详细描述
Pain post reconstructive mammoplasty is common and has an impact on psychosocial aspects, anxiety, sleep disorders and activities of daily living(ADL),as a result patients suffer from impairment in quality of life.
To manage pain pharmaceutical and non-pharmaceutical interventions could be used.
Benson relaxation is a deep breathing relaxation therapy that has been developed by involving a person's belief factor. It works by shifting the focus of pain so that the body becomes relaxed, this can increase endogenous analgesics and be strengthened again by reciting spiritual sentences that provide calm.
Benson relaxation technique has a major effect on reducing anxiety, depression, and improving quality of life and psychological factors. Furthermore, this technique is easy to learn and no side effects have been reported.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Only female patients underwent reconstruction mammoplasty will participate in the study.
- •Female patients who stopped chemotherapy at least one month before participation in the study.
- •Female patients with chronic pain following cosmetic breast surgery.
- •All patients who will accept to participate in the study after one week from operation.
排除标准
- •Patients have irritable bowel syndrome.
- •Patients have urinary incontinence.
- •Chronic diseases like multiple sclerosis, polyneuropathy , diabetes and fibromyalgia.
- •Patients have cognitive disorder.
- •Patients with chronic and severe back pain.
- •Sepsis with complications postoperative hemodynamics.
- •Patients take anti-psychotic drugs.
- •Patients take hypnotic drugs.
研究组 & 干预措施
Benson relaxation technique and routine physiotherapy program group
This group will receive Benson relaxation technique for duration up to 20 min twice daily in addition to medical therapy and a routine physical therapy program for 40 minutes, twice daily for 4 weeks.
干预措施: Benson relaxation technique (Other)
Benson relaxation technique and routine physiotherapy program group
This group will receive Benson relaxation technique for duration up to 20 min twice daily in addition to medical therapy and a routine physical therapy program for 40 minutes, twice daily for 4 weeks.
干预措施: Routine physiotherapy program (Other)
Benson relaxation technique and routine physiotherapy program group
This group will receive Benson relaxation technique for duration up to 20 min twice daily in addition to medical therapy and a routine physical therapy program for 40 minutes, twice daily for 4 weeks.
干预措施: Medications (Drug)
routine physiotherapy program group
This group will receive medical therapy and a routine physical therapy program for 40 minutes, twice daily for 4 weeks.
干预措施: Routine physiotherapy program (Other)
routine physiotherapy program group
This group will receive medical therapy and a routine physical therapy program for 40 minutes, twice daily for 4 weeks.
干预措施: Medications (Drug)
结局指标
主要结局
Assessment of pain severity
时间窗: 4 weeks
Visual analogue scale is a popularly used standardized scale for assessing pain intensity. It is 10 point horizontal line scale ranging from 0 to 10. The participants of both groups will be asked to mark the point representing their pain level before and after the intervention, with 0 meaning no pain and 10 meaning the worst pain.
Assessment of quality of life
时间窗: 4 weeks
The WHOQOL-BREF scale will be used to assess quality of life for all participants before and after the treatment program It is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The highest possible score on the WHOQOL-BREF scale is 100. This score represents the best possible quality of life.
次要结局
未报告次要终点
研究者
Mohamed Abd El-Monem Morad
Principal investigator
Cairo University