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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disorder; Pressure Ulcer; Spine Degeneration; Body Structure, Altered From Its Original Anatomical Structure
• Intervention / Treatment: Behavioral: Changing behaviour

• Study Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

• Study Contact: Name: Ceyhun Türkmen, Ph.D.; Phone Number: +905311017392; Email: fztceyhunturkmen@karatekin.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

210 participants (105 women, 105 men) between the ages of 18-85 with 7 different posture types (Normal posture, Lordotic posture, "sway back" posture, straight waist posture, head forward posture, scoliotic posture and kyphotic posture) will be included in this study. .

Description

Inclusion Criteria:

• Volunteer to participate in research

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Posture	Behavioral: Changing behaviour; Changing the lying position and mattress system
Lordotic Posture	Behavioral: Changing behaviour; Changing the lying position and mattress system
Sway Back Posture	Behavioral: Changing behaviour; Changing the lying position and mattress system
Hypolordotic Back Posture	Behavioral: Changing behaviour; Changing the lying position and mattress system
Head Anterior Tilt Posture	Behavioral: Changing behaviour; Changing the lying position and mattress system
Scoliotic Posture	Behavioral: Changing behaviour; Changing the lying position and mattress system
Kyphotic Posture	Behavioral: Changing behaviour; Changing the lying position and mattress system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Total Body Pressure	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.	40 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hacettepe University

Publications and helpful links

General Publications

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Cullum N, McInnes E, Bell-Syer SE, Legood R. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2004;(3):CD001735. doi: 10.1002/14651858.CD001735.pub2.
• Jacobson BH, Gemmell HA, Hayes BM, Altena TS. Effectiveness of a selected bedding system on quality of sleep, low back pain, shoulder pain, and spine stiffness. J Manipulative Physiol Ther. 2002 Feb;25(2):88-92. doi: 10.1067/mmt.2002.121410.
• Kripke DF, Garfinkel L, Wingard DL, Klauber MR, Marler MR. Mortality associated with sleep duration and insomnia. Arch Gen Psychiatry. 2002 Feb;59(2):131-6. doi: 10.1001/archpsyc.59.2.131.
• Low FZ, Chua MC, Lim PY, Yeow CH. Effects of Mattress Material on Body Pressure Profiles in Different Sleeping Postures. J Chiropr Med. 2017 Mar;16(1):1-9. doi: 10.1016/j.jcm.2016.09.002. Epub 2016 Oct 21.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2022
• Primary Completion (Anticipated): April 15, 2024
• Study Completion (Anticipated): June 15, 2024

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Skin Diseases; Neurologic Manifestations; Skin Ulcer; Sleep Wake Disorders; Pressure Ulcer
• Other Study ID Numbers: 28-06-22/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No