The Effect of Repositioning Frequency Determined According to BMI on Pressure Ulcer Development Time
NCT ID: NCT05504980
Last Updated: 2024-08-28
Study Results
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Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2022-07-01
2023-06-30
Brief Summary
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The sample size was determined as 66 people by power analysis. However, considering the losses, the number of patients included in the sample will 30% higher than the calculated value and it was planned to include 86 patients (43 intervention group, 43 control group) in the study. In the first 24 hours of hospitalization, body mass index will be calculated by skinfold thickness measurement, and data will be collected using the "Structured Questionnaire" for patients with no pressure sores, bedridden, high and very high risk according to the Braden Risk Assessment Scale. In calculating the body mass index of bedridden patients, skinfold thickness measurement, measurement of the interface pressure, which is the most important factor in the development of pressure sores, and calf circumference measurement will be performed to determine the decrease in muscle mass. The research will continue with position change applications between 08-24 hours every day of the week. Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively. Patients in the control group will be given 30 degrees right lateral, supine and 30 degrees left lateral positions, respectively, at 2 hour intervals according to the hospital routine practice. In the initial evaluation, the interface pressure will be measured with the Palm Q-Portable Interface Pressure Sensor from the occipital, scapula, sacrum, heels when the patients are in the supine position, and from the pressure points of the acromion, greater thoracantary, and malleolus prominence when they are in the 30 degrees right and 30 degrees left lateral positions. Patients will be evaluated first within the first 24 hours of hospitalization and on day 21 if a pressure ulcer develops or does not develop a pressure sore a second time.
If the study is successful, it is expected that pressure ulcers will not develop in patients who are positioned at more frequent intervals.
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Detailed Description
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Pressure sores slow down the healing process, prolong the hospital stay, increase the risk of complications, and therefore adversely affect the quality of life of the patients. It increases the cost of maintenance and threatens life. Prevention of pressure sores and early diagnosis of possible tissue damage is important. For this, measures should be taken to eliminate or reduce the effects of risk factors by evaluating them correctly.
In the researches, the importance of body mass index, which plays a role in the development of pressure sores, has been determined. External pressure, which varies according to the body mass index, the physical characteristics of the patient and the characteristics of the support surface used, is the most important factor that plays a role in the development of pressure sores. Pressure sores occur due to external pressure.
The interface pressure, which occurs during the transmission of external pressure to the subcutaneous tissues between the support surface and the skin, may be different in people with different body structures. In studies, it is stated that collagen, muscle mass, adipose tissue density and body mass index around the capillaries affect the interface pressure. It is known that the density of collagen, muscle mass and adipose tissue is different in people with different body mass indexes.
It is important to keep the interface pressure low to allow the return of blood flow to prevent the formation of pressure-related wound.
For this, it is thought that by changing the frequency of repositioning, the interface pressure will prevent blood flow for a long time and tissue damage will be prevented.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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İntervention group
Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively.
Repositioning
Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively.
Control group
Patients in the control group will be given 30 degrees right lateral, supine and 30 degrees left lateral positions, respectively, at 2 hour intervals according to the hospital routine practice.
No interventions assigned to this group
Interventions
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Repositioning
Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively.
Eligibility Criteria
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Inclusion Criteria
* Pressure ulcer not yet developed
* In the first 24 hours of hospitalization, it was evaluated according to the Braden Risk Assessment Scale and determined to be at high risk (range of 10-12 points) for the development of pressure ulcers
Exclusion Criteria
* The position is not considered appropriate by the physician.
* Connected to Mechanical Ventilator
* Presence of septic shock
* Albumin value ≤3.5 mg/dl
18 Years
ALL
Yes
Sponsors
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Aydin Adnan Menderes University
OTHER
Responsible Party
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Ebru Bulut
Principal Investigator
Principal Investigators
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Ebru Bulut, Researcher
Role: PRINCIPAL_INVESTIGATOR
Researcher
Zeynep Günes, Professor
Role: STUDY_DIRECTOR
Researcher
Locations
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Aydin Adnan Menderes University Research and Application Hospital
Aydin, , Turkey (Türkiye)
Countries
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References
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Kimura N, Nakagami G, Minematsu T, Sanada H. Non-invasive detection of local tissue responses to predict pressure ulcer development in mouse models. J Tissue Viability. 2020 Feb;29(1):51-57. doi: 10.1016/j.jtv.2019.11.001. Epub 2019 Nov 4.
Kim S, Kim M, Lee Y, Kim B, Yoon TY, Won CW. Calf Circumference as a Simple Screening Marker for Diagnosing Sarcopenia in Older Korean Adults: the Korean Frailty and Aging Cohort Study (KFACS). J Korean Med Sci. 2018 Apr 26;33(20):e151. doi: 10.3346/jkms.2018.33.e151. eCollection 2018 May 14.
Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.
Mervis JS, Phillips TJ. Pressure ulcers: Prevention and management. J Am Acad Dermatol. 2019 Oct;81(4):893-902. doi: 10.1016/j.jaad.2018.12.068. Epub 2019 Jan 18.
Seo Y, Roh YS. Effects of pressure ulcer prevention training among nurses in long-term care hospitals. Nurse Educ Today. 2020 Jan;84:104225. doi: 10.1016/j.nedt.2019.104225. Epub 2019 Oct 23.
Saghaleini SH, Dehghan K, Shadvar K, Sanaie S, Mahmoodpoor A, Ostadi Z. Pressure Ulcer and Nutrition. Indian J Crit Care Med. 2018 Apr;22(4):283-289. doi: 10.4103/ijccm.IJCCM_277_17.
Neloska L, Damevska K, Nikolchev A, Pavleska L, Petreska-Zovic B, Kostov M. The Association between Malnutrition and Pressure Ulcers in Elderly in Long-Term Care Facility. Open Access Maced J Med Sci. 2016 Sep 15;4(3):423-427. doi: 10.3889/oamjms.2016.094. Epub 2016 Aug 22.
Hyun S, Li X, Vermillion B, Newton C, Fall M, Kaewprag P, Moffatt-Bruce S, Lenz ER. Body mass index and pressure ulcers: improved predictability of pressure ulcers in intensive care patients. Am J Crit Care. 2014 Nov;23(6):494-500; quiz 501. doi: 10.4037/ajcc2014535.
Coleman S, Nixon J, Keen J, Wilson L, McGinnis E, Dealey C, Stubbs N, Farrin A, Dowding D, Schols JM, Cuddigan J, Berlowitz D, Jude E, Vowden P, Schoonhoven L, Bader DL, Gefen A, Oomens CW, Nelson EA. A new pressure ulcer conceptual framework. J Adv Nurs. 2014 Oct;70(10):2222-34. doi: 10.1111/jan.12405. Epub 2014 Mar 31.
Bhattacharya S, Mishra RK. Pressure ulcers: Current understanding and newer modalities of treatment. Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16. doi: 10.4103/0970-0358.155260.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AdnanMenderesU
Identifier Type: -
Identifier Source: org_study_id
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