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

I

Istanbul University - Cerrahpasa (IUC)

Status

Completed

Conditions

Idiopathic Scoliosis
Sleep

Treatments

Device: Mattress 2
Device: Mattress 1

Study type

Interventional

Funder types

Other

Identifiers

NCT05288972
gGqs42M4

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

42 participants in 2 patient groups

Mattress 1
Experimental group
Description:
Mattress 1 group will receive Polyurethane, Bonnel spring, medium-hard mattress
Treatment:
Device: Mattress 1
Mattress 2
Active Comparator group
Description:
Mattress 2 group will receive Polyurethane, pocket spring, medium mattress
Treatment:
Device: Mattress 2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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