Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Self Reported Sleep Quality |
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. |
4 weeks |
|
| Primary |
Sleep Quality with Wearable Actigraph |
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. |
1 week |
|
| Primary |
Sleep Quality with Non-Wearable Actigraph |
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. |
4 weeks |
|
| Secondary |
Subjective Feedback Inquiry |
Subjective Feedback Questionnaire: It consists of questions such as the feeling of comfort in nine body regions (neck, shoulder, back, elbows, waist, hand/wrist, hip/thigh, knee, ankle), feeling of firmness, preference for bed, preference for sinking-buried. It will be marked on a 5-point Likert scale. Scoring is done between 0-5 for each. The higher the score represents better comfort. |
4 weeks |
|
| Secondary |
Pain intensity |
Visual Analog Scale (VAS): Patients will be asked to mark the degree of pain they feel at rest, in motion, and at night on the 10 cm VAS line. The condition that there is no pain is expressed as 0, and the condition that there is too much pain to be tolerated is expressed as 10. Subjects are asked to rate the pain they feel in their back/waist in the evening (before going to bed), at night (sleeping), in the morning (when getting out of bed in the morning), during the day (during the day). High scores indicate an increasing degree of pain. |
4 weeks |
|
| Secondary |
Musculoskeletal Discomfort |
Cornell Musculoskeletal Questionnaire (CMQ): It's a 54-item questionnaire and involves a self-rating of the frequency, severity, and work interference of the musculoskeletal discomfort on three scales across 20 body parts. On the frequency scale, the frequency of experiencing musculoskeletal discomfort in the past week is rated as never(0), 1-2 times per week(1.5), 3-4 times per week(3.5), every day(5), several times per day(10). On the severity scale, the severity of the experienced musculoskeletal discomfort is rated across the following anchors: 'Slightly uncomfortable'(1), 'Moderately uncomfortable (2), and 'Very uncomfortable'(3). On the work interference scale, the interference of the experienced musculoskeletal discomfort with the ability to work is rated across the following anchors: 'Not at all'(1), 'Slightly interfered'(2), and 'Substantially interfered'(3). High scores signify that discomfort frequency, severity, and working ability interference are high. |
4 weeks |
|
| Secondary |
Fatigue |
Multidimensional Assessment of Fatigue (MAF): The scale contains 16 items and measures four dimensions of fatigue: severity (1-2), distress (3), degree of interference in activities of daily living (4-14), and timing (15-16). Scores range from 1 (no fatigue) to 50 (severe fatigue). |
4 weeks |
|
| Secondary |
Functional Status |
The Functional Rating Index (FRI): FRI is a self-reporting instrument consisting of 10 items, each with 5 possible responses (0-4) that express graduating degrees of disability. Scoring ranges from 0-40, and the higher the score, the worse the functional status. |
4 weeks |
|
| Secondary |
Trunk Sagittal Plane Flexibility |
Finger-to-floor test: Finger-to-floor distance test was used to measure lumbar mobility. This test measures the maximal possible spinal flexion range, and the participants bent their bodies forward without flexing their knees until there was a functional limitation. The distance between the tip of the right middle finger and the floor was measured as the finger-to-floor distance score (cm) using standard tape. Higher distances were indicative of greater hamstring tightness and limited lumbopelvic mobility. |
4 weeks |
|
| Secondary |
Trunk Frontal Plane Flexibility |
Finger-to-floor test: Finger-to-floor distance test was used to measure lumbar mobility. This test measures the maximal possible spinal flexion range, and the participants laterally flexed their bodies forward without flexing their knees until there was a functional limitation. The distance between the tip of the third digit and the floor was measured (cm) using standard tape. Higher distances were indicative of greater frontal plane lumbopelvic mobility. |
4 weeks |
|
| Secondary |
Trunk Endurance |
Static endurance of trunk muscles will be evaluated in plank position, supine hook lying position with the trunk flexed to 60 degrees, in the prone Biering-Sorenson Test position (prone with the upper body and abdomen off the edge of the table), and side bridge position. The ability to maintain these positions will be recorded in seconds with a chronometer. Higher time duration indicates higher muscular endurance. |
4 weeks |
|
| Secondary |
The Quality of Life |
The Nottingham Health Profile (NHP): It is a 38-item questionnaire that assesses the domains of physical mobility, pain, sleep, social isolation, emotional reactions, and energy level. All questions have only yes/no answer options and each section score is weighted. Its wording is simple and easily understood, and can be completed by patients in 5 minutes. High scores indicate a decrease in quality of life. The highest score in any section is 100. |
4 weeks |
|
| Secondary |
Soliosis Specific Quality of Life |
Scoliosis Research Society-22 Questionnaire (SRS-22): The questionnaire assesses five domains: function, pain, personal image, mental health (five questions each) and treatment satisfaction (two questions). Each question is scored between 1 (worst) and 5 (best). In the interrogation whose total score ranged from 22 to 111, the high score indicates that the quality of life for scoliosis is better. |
4 weeks |
|
