Comfort and Support Values of Different Pillow Designs

NCT05707715 | Completed

• 1 other identifier: 19/01/2023-30
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

With the change in lifestyle, most physical tasks are now performed by machines. As a result, sitting has become the most common learning posture and office posture, and cervical and lumbar spondylosis are becoming increasingly prevalent in younger people. One-third of life is devoted to sleep, and bad sleeping posture can place incorrect strain on the cervical and lumbar spine, resulting in irreversible and detrimental repercussions if not treated seriously. Sleep disorders have become an important public health concern because they can have detrimental effects on both mental and physical health. A pillow can give adequate support for the head and neck and assist sleepers in maintaining proper neck and thoracic curvature. Studies have demonstrated that a comfortable sleeping pillow helps relax the neck muscles, hence facilitating sleep, and efficiently alleviate pain in the neck, shoulders, back, and head. There is consensus among researchers that supporting the natural lordotic curve of the cervical spine is necessary to achieve longer periods of deep sleep. In addition, a pillow can improve sleep quality by cooling the head, lowering body temperature, reducing sweating or slowing the heart rate during sleep. However, the level of evidence to support these claims is so far limited. It has been claimed by pillow manufacturers that many design-related pillow parameters are effective in improving sleep quality and reducing neck pain. However, most of these recommendations are based on personal experience. This study recommends the most suitable pillow for people in forward head postures based on the body pressure distribution of the head, neck and upper body. The proposed pillows were evaluated in two parameters: comfort and support.

Conditions

Sleep; Proprioceptive Disorders; Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• Comfort and support assessment

  A pressure mapping system (X3 SENSOR PX 100:64.160.02, X-Sensor®, Calgary, Canada) was used to record the pressure distribution in mmHg of the head and shoulder section \[18,19\]. The pressure mapping system used has a sensing area of 81.3 × 203.2 cm (32'' x 80''), provides high resolution sensing (1.27 cm or 0.5'') using 10,240 sensing points with an accuracy of ±2 mmHg. For the purpose of our study, the pressure mapping system was positioned on the pillow and the patients were asked to lie on the mapping system once in supine, side lying and prone positions. The purpose of these measurements was to describe the pressure distribution created by the participants in the pillow and the supported areas, as well as to find out the differences that may occur between the pillows. Lower pressure values measured by the device were defined as "high comfort", while more contact of the head area with the pillow was accepted as "high support".

  15 minutes

Study Arms (2)

Slight Forward Head Posture

This descriptive cross-sectional study which was approved by Çankırı Karatekin University Ethics Committee (Approval number:). There is FHP if the imaginary line between the tragus of the ear and the middle of the shoulder is not on the same line when viewed from the side. And the horizontal length between that two vertical lines indicates the severity of FHP. The level of FHP is classified as slight/severe/highly FHP according to that horizontal length. The slight FHP is accepted as between 0-2.5cm, and severe FHP above 2.5cm (27).

Device: XSensor

Severe Forward Head Posture

This descriptive cross-sectional study which was approved by Çankırı Karatekin University Ethics Committee (Approval number:). There is FHP if the imaginary line between the tragus of the ear and the middle of the shoulder is not on the same line when viewed from the side. And the horizontal length between that two vertical lines indicates the severity of FHP. The level of FHP is classified as slight/severe/highly FHP according to that horizontal length. The slight FHP is accepted as between 0-2.5cm, and severe FHP above 2.5cm (27).

Device: XSensor

Interventions

XSensor DEVICE

A pressure mapping system (X3 SENSOR PX 100:64.160.02, X-Sensor®, Calgary, Canada) was used to record the pressure distribution in mmHg of the head and shoulder section \[18,19\]. Pressure distribution was recorded for 1 minute for each lying position. The purpose of these measurements was to describe the pressure distribution created by the participants in the pillow and the supported areas, as well as to find out the differences that may occur between the pillows. Lower pressure values measured by the device were defined as "high comfort", while more contact of the head area with the pillow was accepted as "high support".

Severe Forward Head Posture; Slight Forward Head Posture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals

You may qualify if:

• Forward head posture
• Good cognitive status (Mini Mental Test \>23/30

You may not qualify if:

• Orthopeadical or Neurological chronic disorders
• Spinal disraphism
• Spinal rheumotological disorders

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

ODTU Teknopark ASO

Ankara, Turkey (Türkiye)

Location

Related Publications (7)

• Andreoni G, Santambrogio GC, Rabuffetti M, Pedotti A. Method for the analysis of posture and interface pressure of car drivers. Appl Ergon. 2002 Nov;33(6):511-22. doi: 10.1016/s0003-6870(02)00069-8.

  PMID: 12507335 RESULT

• Le P, Rose J, Knapik G, Marras WS. Objective classification of vehicle seat discomfort. Ergonomics. 2014;57(4):536-44. doi: 10.1080/00140139.2014.887787. Epub 2014 Mar 7.

  PMID: 24606493 RESULT

• de Looze MP, Kuijt-Evers LF, van Dieen J. Sitting comfort and discomfort and the relationships with objective measures. Ergonomics. 2003 Aug 15;46(10):985-97. doi: 10.1080/0014013031000121977.

  PMID: 12850935 RESULT

• Miyatsuji A, Matsumoto T, Mitarai S, Kotabe T, Takeshima T, Watanuki S. Effects of clothing pressure caused by different types of brassieres on autonomic nervous system activity evaluated by heart rate variability power spectral analysis. J Physiol Anthropol Appl Human Sci. 2002 Jan;21(1):67-74. doi: 10.2114/jpa.21.67.

  PMID: 11938611 RESULT

• Zhong S, Shen L, Zhou L, Guan Z. Predict human body indentation lying on a spring mattress using a neural network approach. Proc Inst Mech Eng H. 2014 Aug;228(8):787-99. doi: 10.1177/0954411914547552. Epub 2014 Aug 22.

  PMID: 25150192 RESULT

• Leilnahari K, Fatouraee N, Khodalotfi M, Sadeghein MA, Kashani YA. Spine alignment in men during lateral sleep position: experimental study and modeling. Biomed Eng Online. 2011 Nov 30;10:103. doi: 10.1186/1475-925X-10-103.

  PMID: 22129355 RESULT

• Diab AA, Moustafa IM. The efficacy of forward head correction on nerve root function and pain in cervical spondylotic radiculopathy: a randomized trial. Clin Rehabil. 2012 Apr;26(4):351-61. doi: 10.1177/0269215511419536. Epub 2011 Sep 21.

  PMID: 21937526 RESULT

MeSH Terms

Conditions

Somatosensory Disorders; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: February 1, 2023
• Study Start: January 22, 2023
• Primary Completion: February 10, 2023
• Study Completion: March 14, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)