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

NCT ID: NCT05288972

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-03
• Study Completion Date: 2023-03-15

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.

Conditions

Idiopathic Scoliosis; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Mattress 1

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

Group Type: EXPERIMENTAL

Mattress 1

Intervention Type: DEVICE

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.

Mattress 2

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

Group Type: ACTIVE_COMPARATOR

Mattress 2

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yataş Yatak ve Yorgan San. Tic. A.Ş.

UNKNOWN

Sponsor Role: collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Ayse Zengin Alpozgen

Asst.Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ipek Yeldan Karagoz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Istanbul University Cerrahpasa, Faculty of Health Science

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

gGqs42M4

Identifier Type: -

Identifier Source: org_study_id