Efficacy of Designed Exercise Program on Pain and Quality of Sleeping in Patient With Sickle Cell Disease Anemia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
Background: Pain and sleep disturbance are the most common problems experienced by adult patients with sickle cell disease anemia. Aim: the aim of this study is to evaluate the efficacy of designed exercise program on pain, and quality of sleeping in adult patients with sickle cell disease anemia and how the program affects their quality of lives. Subjects and methods: Adults patients with sickle cell diseases aging over 18 years old. Data will be collected in face-to-face interviews. Eligible participants will be equally and randomized into two groups. Group-1: Twenty-five adult patients with SCD will receive a designed exercise program of physical therapy for relief pain and improve sleep quality (experimental group). The designed exercise program will be distributed on everyone. The recommendations will be to train from 30 to 45 minutes, three days per week for 6 weeks in addition to walking daily 30 minutes on the ground surface. Group-2: Twenty-five adult patients with SCD will participate as a control group they will not receive exercise program. Analysis: The collected data will be managed by using t -test and the repeated measures of ANOVA test to compare the significance within groups and between two groups.
详细描述
Methodology:
Design: Randomized clinical trial (RCT). Subjects' criteria: Fifty adult sickle cell disease patients who are aged more than 18 years with different socio-economic and educational levels. Patients with sickle cell anemia will be distributed into two groups. All personal data will be collected.
Group-1: Twenty-five adult patents with SCD will receive a designed exercise program of physical therapy for relief pain and improve sleeping quality (experimental group). The designed exercise program will be distributed on everyone. The recommendations will be to train from 30 to 45 minutes, three days per week for 6 weeks in addition to walking daily 30 minutes on the ground surface.
Group-2: Twenty-five adult patients with SCD will participate as a control group they will not receive exercise program.
Assessment instruments:
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
- Double (Participant, Outcomes Assessor)
盲法说明
To prevent human bias regarding to participants and outcomes assessor
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCD patient
- •Their age from18 -55 years
- •have no communication problems
- •They able to perform the exercises
排除标准
- •Their age less than 18
- •They unable to do the exercises.
- •They had communication problems
研究组 & 干预措施
Group-I
Group-1: Twenty-five adult patients with SCD will receive a designed exercise program of physical therapy for relief pain and improve sleep quality (experimental group). The designed exercise program will be distributed on everyone. The recommendations will be to train from 30 to 45 minutes, 3 days per week for 6 weeks in addition to walking 30 minutes on the ground surface daily.
干预措施: Exercise training program (Other)
Group-II
Group-2: Twenty-five adult patients with SCD will participate as a control group they will not receive exercise program.
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: 10 minutes
The (PSQI) is a 19-item instrument created to measure different aspects of sleep quality and sleep disturbance (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). The scale reports quality of sleeping over the past month. The PSQI is divided into 7 subscale scores: subjective sleep quality; sleep latency (time of full sleep); duration; habitual sleep efficiency (proportion between total sleep time and time in bed); sleep disturbances (waking up during the night); use of medication to sleep; and daytime dysfunction (difficulty staying awake during daytime). The overall score ranges between 0 and 21, and a total score of more than 5 indicates poor sleep quality(Al Maqbali et al., 2020).
Visual Analog Scale:
时间窗: 5 minutes
VAS: It is a safe, valid, and reliable measurement instrument used to evaluate pain severity. It was designed by Huskisson to quantify values that could not be measured in numbers. The most important advantage of the test is the lack of a language barrier and simplicity of application. The definition of the parameter to be assessed is written at the two ends of a 10 cm line, and the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks (Kazak and Ozkaraman, 2021, Crichton, 2001).
次要结局
- The Fatigue Scale(5 minutes)
- The Perceived Stress Scale(3 minutes)
- WHOQOL-BREF:(5 minutes)
研究者
Eyad Alshurafa
ealshurafa
Imam Abdulrahman Bin Faisal University