The Effect of Different Mattress Types on Sleep Quality in Adult Individuals With Idiopathic Scoliosis

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05288972

Collaborator

Yataş Yatak ve Yorgan San. Tic. A.Ş. (Other)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Scoliosis Sleep	Device: Mattress 1 Device: Mattress 2	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 3, 2022

Anticipated Primary Completion Date :

Dec 16, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mattress 1 Mattress 1 group will receive Polyurethane, Bonnel spring, medium-hard mattress	Device: Mattress 1 A mattress (M1) with the technical features suitable for scoliosis with supports the spine properly. The mattress will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day.
Active Comparator: Mattress 2 Mattress 2 group will receive Polyurethane, pocket spring, medium mattress	Device: Mattress 2 A mattress with standard technical features (M2). The mattress will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day.

Arm

Intervention/Treatment

Experimental: Mattress 1

Mattress 1 group will receive Polyurethane, Bonnel spring, medium-hard mattress

Device: Mattress 1

A mattress (M1) with the technical features suitable for scoliosis with supports the spine properly. The mattress will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day.

Active Comparator: Mattress 2

Mattress 2 group will receive Polyurethane, pocket spring, medium mattress

Device: Mattress 2

A mattress with standard technical features (M2). The mattress will use for 4 weeks, at least 5 days a week, including at least 6 hours of sleep per day.

Outcome Measures

Primary Outcome Measures

Self Reported Sleep Quality [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 [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 [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.

Secondary Outcome Measures

Subjective Feedback Inquiry [4 weeks]
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.
Pain intensity [4 weeks]
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.
Musculoskeletal Discomfort [4 weeks]
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.
Fatigue [4 weeks]
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).
Functional Status [4 weeks]
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.
Trunk Sagittal Plane Flexibility [4 weeks]
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.
Trunk Frontal Plane Flexibility [4 weeks]
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.
Trunk Endurance [4 weeks]
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.
The Quality of Life [4 weeks]
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.
Soliosis Specific Quality of Life [4 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with idiopathic scoliosis
Cobb angle between 10 and 50 degrees
Age 18-45 years
Last mattress use period > 6 months

Exclusion Criteria:

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