NCT05288972

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Scoliosis
• Sleep

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-04-03
• Primary completion: 2023-03-01
• Completion: 2023-03-15
• First posted: 2022-03-21
• Last updated: 2023-06-07

Locations

1 site across 1 country: Turkey (Türkiye)