Adaptation of Mattresses Made With Different Materials to Personal Anthropometry Values and Body Postures

• Conditions: Pressure Ulcer; Spine Degeneration; Body Structure, Altered From Its Original Anatomical Structure; Sleep Disorder
• Interventions: Behavioral: Changing behaviour

• Registration Number: NCT05486039
• Lead Sponsor: Hacettepe University

Brief Summary

Sleep disorders affect 40% of the adult population each year and are often associated with morbidity and mortality (Kripke et al., 2002; F.-Z. Low et al., 2017). Sleep quality plays a vital role in the overall quality of our lives. Therefore, a good sleep helps to create a quality life rhythm. A quality sleep reduces fatigue and increases physical regeneration (Khaleghipour et al., 2015). Poor sleep quality is due to various environmental factors such as temperature, light, noise and bed quality (Lei et al., 2009). It has been reported that 7% of sleep problems are caused by inappropriate mattresses that affect the load on the spine during sleep (F. Z. Low et al., 2017). Body contact pressure is a measure of the distribution of body weight across the body surface in contact with the mattress. A well-designed mattress usually has the ability to minimize high pressure points applied to the body. However, if the bed is not suitable for the person, pressure sores may develop in the body parts where pressure is intense (Cullum et al., 2004). The areas most affected by high pressure are usually the hips, shoulders and back, which can affect sleep quality and result in drowsiness or body stiffness throughout the day (Jacobson et al., 2002). A recent study by Bae and Ko compared the bed positions of hospital beds and found that a head-to-foot angle of 30° is the best position to reduce the likelihood of decubitus ulcers occurring in patients in high-pressure risk areas (Bae \& Ko, 2013). In the light of previous studies, it has been observed that there is no study comparing many bed types designed using different materials for individual-specific postures. Biomechanical comparison of these bedding materials in individuals with different posture types and sleeping in different sleeping positions will allow us to provide new insights into their pressure distribution abilities. The aim of this study is to measure the effect of mattresses made of different mattress materials on body contact pressure profiles in individuals with different postures in various sleeping positions. It will be evaluated using maximum body pressure and pressure distribution as outcome measures.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-03
• Last Update Posted: 2022-08-03
• Study Start: 2022-10-15
• Primary Completion: 2024-04-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Volunteer to participate in research

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Exclusion Criteria

• Having a history of back, shoulder or neck pain in the last 6 weeks
• Having a surgical operation in the last 8 weeks

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypolordotic Back Posture	Changing behaviour	-
Kyphotic Posture	Changing behaviour	-
Normal Posture	Changing behaviour	-
Lordotic Posture	Changing behaviour	-
Sway Back Posture	Changing behaviour	-
Head Anterior Tilt Posture	Changing behaviour	-
Scoliotic Posture	Changing behaviour	-

Primary Outcome Measures

Name	Time	Method
Measurement of Total Body Pressure	40 minutes	A pressure mat sensor (Pressure Mapping Sensor 5400N, Tekscan, Boston, MA) will first be calibrated on different beds using constant weights and then used to capture body contact pressure profiles in a video format for 6 minutes per stop at a sampling rate. 4 Hz Collected data will be edited in Matlab (MathWorks, Natick, MA) format for later recording. The posture screen analysis system will be used to determine the posture type of individuals.

Secondary Outcome Measures

Name	Time	Method
Pittsburg Health Quality Index	40 minutes	The Pittsburg Sleep Quality Scale will be used to obtain more detailed data on current sleep quality from individuals (Buysse et al., 1989).