Pressure UlcerNCT05486039
Adaptation of Mattresses Made With Different Materials to Personal Anthropometry Values and Body Postures
An observational study of Pressure Ulcer and Sleep Disorder, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Sleep Disorder, Spine Degeneration
- What is being tested?
- Changing behaviour
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2022to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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. .
Who may be able to join
- Volunteer to participate in research
Who cannot join
- Having a history of back, shoulder or neck pain in the last 6 weeks
- Having a surgical operation in the last 8 weeks
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Pressure Ulcer, Sleep Disorder, Spine Degeneration, Body Structure, Altered From Its Original Anatomical Structure
- Being tested
- Changing behaviour
- Medical subject headings
- Pressure Ulcer, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing behaviourBehavioural
Changing the lying position and mattress system
| Study group | Role | What they receive |
|---|---|---|
| Normal Posture | Not described Receives: Behavioral: Changing behaviour | |
| Lordotic Posture | Not described Receives: Behavioral: Changing behaviour | |
| Sway Back Posture | Not described Receives: Behavioral: Changing behaviour | |
| Hypolordotic Back Posture | Not described Receives: Behavioral: Changing behaviour | |
| Head Anterior Tilt Posture | Not described Receives: Behavioral: Changing behaviour | |
| Scoliotic Posture | Not described Receives: Behavioral: Changing behaviour | |
| Kyphotic Posture | Not described Receives: Behavioral: Changing behaviour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 minutes
Secondary outcomes (1)
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).
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start15 Oct 2022 (estimated)
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Turkmen, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486039
- Sponsor's protocol ID
- 28-06-22/26
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 2748771Cullum 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.
PubMed 15266452Jacobson 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.
PubMed 11896375Kripke 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.
PubMed 11825133Low 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.
PubMed 28228692
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Mattresses Made With Different Materials to Personal Anthropometry Values and Body Postures
- ClinicalTrials.gov ID
- NCT05486039
- Acronym / sponsor ID
- 28-06-22/26
- Conditions
- Pressure Ulcer, Sleep Disorder, Spine Degeneration, Body Structure, Altered From Its Original Anatomical Structure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Normal Posture | – | Behavioral: Changing behaviour |
| Lordotic Posture | – | Behavioral: Changing behaviour |
| Sway Back Posture | – | Behavioral: Changing behaviour |
| Hypolordotic Back Posture | – | Behavioral: Changing behaviour |
| Head Anterior Tilt Posture | – | Behavioral: Changing behaviour |
| Scoliotic Posture | – | Behavioral: Changing behaviour |
| Kyphotic Posture | – | Behavioral: Changing behaviour |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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. .
Key inclusion criteria (1 listed)
- Volunteer to participate in research
Key exclusion criteria (2 listed)
- Having a history of back, shoulder or neck pain in the last 6 weeks
- Having a surgical operation in the last 8 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changing behaviourChanging the lying position and mattress system | Behavioural | Head Anterior Tilt Posture, Hypolordotic Back Posture, Kyphotic Posture, Lordotic Posture, Normal Posture, Scoliotic Posture, Sway Back Posture |
Primary outcome
Measurement of Total Body Pressure
Time frame: 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.
1 secondary outcome
Pittsburg Health Quality Index
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Results publication: PubMed 2748771Buysse 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.
- Results publication: PubMed 15266452Cullum 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.
- Results publication: PubMed 11896375Jacobson 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.
- Results publication: PubMed 11825133Kripke 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.
- Results publication: PubMed 28228692Low 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer and Sleep Disorder, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ceyhun Türkmen, Ph.D. (+905311017392, fztceyhunturkmen@karatekin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Total Body Pressure (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486039, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.