The Effect of Different Mattress Types on Sleep Quality, Pain, Fatigue, Physical Adaptation, Functional Status, and Quality of Life in Adult Individuals With Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Self Reported Sleep Quality
研究概览
简要总结
Objective: The aim of this study is to investigate the effect of different mattress materials on sleep behavior in adults with idiopathic scoliosis treated with non-invasive techniques.
Hypothesis 0: The use of a mattress that supports the spine properly, together with sleep accessories such as pillows, does not affect sleep behavior, does not alleviate back pain, and does not affect overall sleep quality and duration in adults with scoliosis.
Hypothesis 1: The use of a mattress that supports the spine properly, along with sleep accessories such as pillows, affects sleep behavior, helps relieve back pain, and affects overall sleep quality and duration in adults with scoliosis.
Possible outcomes: Improving sleep behavior and supporting the quality of life of individuals with idiopathic scoliosis.
详细描述
Scoliosis, which is characterized by the curvature of the spine to the right or left, is a common orthopedic problem today. Due to the restriction of mobility and various symptoms of the disease, people may experience difficulties in their daily lives. The clinical manifestation of scoliosis in adults is most often characterized by the presence of back pain. Unbalanced, overloaded, and strained back muscles are under constant pressure and contribute greatly to back pain. The pain may be localized at the apex of the curve (apex) or around the concavity or may radiate down the leg. This can affect people's fatigue, physical adaptation, functional status, and quality of life. This study aims to examine sleep behavior and to investigate the effects of different mattress materials on pain, sleep quality, fatigue, physical adaptation, functional status, and quality of life in adults with idiopathic scoliosis treated with non-invasive techniques.
Voluntary participants who have been diagnosed with idiopathic scoliosis will be included in the study. Signed voluntary consent will be obtained from participants. The participants will be divided into 2 groups by block randomization according to the curve type and severity and will be evaluated as double-blind.
The first group will be given a mattress (M1) with the technical features suitable for scoliosis with supports the spine properly, and the control group will be given a mattress with standard technical features (M2). The mattresses will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with idiopathic scoliosis
- •Cobb angle between 10 and 50 degrees
- •Age 18-45 years
- •Last mattress use period > 6 months
排除标准
- •Surgical history (last 2 years)
- •Lung problems, chronic respiratory or neuromuscular disease,
- •Back Depression Scale score ≥ 17 & taking antidepressants
- •Insomnia Severity Index score ≥ 7 & Using sleeping pills/hormones
- •Diagnosed with a sleep disorder (history of restless sleep, sleep apnea...)
- •Non-vertebral pain that affects sleep behavior
- •Presence of a newly developed condition in the last 6 months that will affect sleep quality
- •A change in the conservative treatment for scoliosis in the last 3 months, or a change is planned
- •BMI <18.5 or >30 kg/m2
结局指标
主要结局
Self Reported Sleep Quality
时间窗: 4 weeks
Pittsburgh Sleep Quality Scale: It is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. Each item of the test is scored equally between 0-3. The scale consists of 7 subscales that assess subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleep medication, and loss of daytime functionality. By summing up the subscales, a total score ranging from 0 to 21 is obtained. A total score greater than five, with 89.6% sensitivity and 86.5% specificity, indicates inadequate sleep quality and indicates severe impairment in at least two of the above-mentioned areas or moderate impairment in three areas.
Sleep Quality with Wearable Actigraph
时间窗: 1 week
Wearable Actigraph: The wearable actigraphs to be used in the study are small, lightweight, portable devices that can be worn in the form of a watch, measuring sleep and wake cycles, and sensitively detecting motor activities. In the study, wearable sleep actigraphs (Actigraph wgt3x-bt) will be used by attaching them to the non-dominant wrists of the participants, thus enabling the recording and storage of resting and activity patterns in a digital environment. Each participant will be asked to wear the wearable sleep actigraph in the form of a watch for 7 days (5 weekdays and 2 weekend days) during the last week of the study, and sleep data will be recorded. The recorded data will be transferred to the computer and after the transfer, the device will be reformatted and prepared for new recordings.
Sleep Quality with Non-Wearable Actigraph
时间窗: 4 weeks
Non-Wearable Actigraph: Non-wear actigraphs (Reston Z200) to be used in the study are made ready for use by laying them on the bed. While the cord of the device is laid inside the bed, the device is suspended from the side of the bed. Bed linen is placed on it. Thus, it does not disturb the person during sleep. Each participant will be asked to use the no-wear sleep actigraph laid on their bed every day (5 weekdays and 2 weekend days) throughout the study (4 weeks). With a free application installed on the smartphone, 30 days of sleep data will be recorded.
次要结局
- Musculoskeletal Discomfort(4 weeks)
- Fatigue(4 weeks)
- Soliosis Specific Quality of Life(4 weeks)
- Subjective Feedback Inquiry(4 weeks)
- Pain intensity(4 weeks)
- Functional Status(4 weeks)
- Trunk Sagittal Plane Flexibility(4 weeks)
- Trunk Frontal Plane Flexibility(4 weeks)
- Trunk Endurance(4 weeks)
- The Quality of Life(4 weeks)
研究者
Ayse Zengin Alpozgen
Asst.Prof.
Istanbul University - Cerrahpasa (IUC)