Clinical trial NCT05288972: The Effect of Different Mattress Types on Sleep Quality in Adult Individuals With Idiopathic Scoliosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Scoliosis
Sleep
Keywords: spine
scoliosis
mattress
fatique
pain
quality of life
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Yataş Yatak ve Yorgan San. Tic. A.Ş.
First posted: 2022-03-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self Reported Sleep Quality
timeFrame: 4 weeks
measure: Sleep Quality with Wearable Actigraph
timeFrame: 1 week
measure: Sleep Quality with Non-Wearable Actigraph
timeFrame: 4 weeks
Secondary outcomes:
measure: Subjective Feedback Inquiry
timeFrame: 4 weeks
measure: Pain intensity
timeFrame: 4 weeks
measure: Musculoskeletal Discomfort
timeFrame: 4 weeks
measure: Fatigue
timeFrame: 4 weeks
measure: Functional Status
timeFrame: 4 weeks
measure: Trunk Sagittal Plane Flexibility
timeFrame: 4 weeks
measure: Trunk Frontal Plane Flexibility
timeFrame: 4 weeks
measure: Trunk Endurance
timeFrame: 4 weeks
measure: The Quality of Life
timeFrame: 4 weeks
measure: Soliosis Specific Quality of Life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa, Faculty of Health Science
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ipek Yeldan Karagoz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: