- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438899
The Effect of Pressure Injury Training on Knowledge Levels and Wound Prevention in Wheelchair Users
Evaluation of the Effects of Training Given to Wheelchair Users on Their Level of Knowledge, Prevention of Pressure Injury and Wound Healing
This research is a randomised controlled study conducted to evaluate the effects of training given to wheelchair users to prevent pressure injury on their level of knowledge, prevention of pressure injury and wound healing.
This study will test the following hypotheses among trained and untrained wheelchair users:
Hypothesis 1: Pressure injury education provided to wheelchair users has an impact on pressure injury prevention knowledge.
Hypothesis 2: Pressure injury education provided to wheelchair users has an impact on pressure injury prevention interventions.
Hypothesis 3: Pressure injury education provided to wheelchair users has an impact on pressure injury prevention.
Hypothesis 4: Pressure injury education provided to wheelchair users has an impact on pressure injury recovery.
Study Overview
Status
Intervention / Treatment
Detailed Description
Detailed Description
This randomized controlled trial was designed to evaluate the effectiveness of an online pressure injury education program developed for individuals who use wheelchairs. The intervention aimed to improve participants' knowledge related to pressure injury prevention, to support the implementation of preventive behaviors, and to contribute to the prevention and healing processes of pressure injuries through structured online education and follow-up.
The study was conducted between 2021 and 2023 in Tokat province, Türkiye. Eligible participants were allocated to intervention and control groups using a stratified randomization method to ensure balance between groups. The study was carried out as a double-blind randomized controlled trial, in which both participants and the statistician responsible for data analysis were blinded to group assignments.
The intervention consisted of a structured online training program focusing on pressure injury risk factors, prevention strategies, skin assessment, positioning, and wound care principles relevant to wheelchair users. Participants in the intervention group were divided into small training groups, and the education was delivered through multiple online sessions to enhance interaction and understanding. The control group received routine follow-up without the educational intervention during the study period.
Following completion of the training program, both groups were monitored over a 12-week follow-up period. Weekly follow-ups were conducted to observe changes related to pressure injury prevention practices and healing status. Outcome assessments were performed at baseline and at the end of the follow-up period to evaluate the impact of the intervention.
The study was approved by the Gazi University Ethics Committee, and official permission was obtained from the Tokat Governorship. All participants provided informed consent prior to participation. The findings of this study are expected to contribute evidence regarding the role of online education in pressure injury prevention and management among wheelchair users.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selcuklu
-
Konya, Selcuklu, Turkey (Türkiye)
- selcukU
-
-
Selçuklu
-
Konya, Selçuklu, Turkey (Türkiye), 42130
- Selcuk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged between 18 and 65 years
Wheelchair user
No communication difficulties
Willing to participate voluntarily in the study
Healthy volunteer
Exclusion Criteria:
Younger than 18 years or older than 65 years
Presence of any communication difficulties
Unwilling to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: education, monitoring and counseling
Participants in the experimental group who used wheelchairs received three-session training on preventing pressure sores.
This was followed by a 12-week follow-up and counseling program.
|
To provide interactive training sessions to the intervention group, four training groups were formed, each consisting of 9-10 people.
Each training session, comprising three sessions, was completed over two weeks on the Zoom platform.
Each 60-minute session included information on the definition, etiology, influencing factors, and prevention and care practices for cognitive impairment.
Following the completion of the training sessions, individuals in the intervention group were followed up and provided with counseling for 12 weeks.
Other Names:
|
|
No Intervention: monitoring
Participants in the control group who used wheelchairs received training and were only monitored for the development of pressure injury for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of mean scores from the "Pressure Injury Knowledge Test for Wheelchair Users" scale between the intervention and control groups.
Time Frame: 3,5 months
|
Using the "Pressure Injury Knowledge Test for Individuals Using Wheelchairs" scale, a pretest was administered to the experimental and control groups before the training to assess pressure injury knowledge levels.
Subsequently, three sessions of training were administered only to the experimental group.
|
3,5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of individuals in the intervention group's implementation of pressure injury prevention practices using the "Pressure Ulcer Healing Assessment Form"
Time Frame: 3,5 months
|
After receiving pressure ulcer training, individuals in the intervention group were assessed once a week during a 12-week follow-up period to determine whether they implemented pressure ulcer prevention practices, and their data were analyzed.
|
3,5 months
|
|
Statistical comparison of Pressure Ulcer Healing Assessment Scale (PRS) scores between the experimental and control groups
Time Frame: 1 month
|
The wounds of all participants in the intervention and control groups who had existing wounds and those who developed new wounds during the 12-week follow-up period were monitored weekly with the Pressure Ulcer Healing PUSH scale, and the results were analyzed.
|
1 month
|
|
Evaluation of whether there is a statistically significant difference between the groups when comparing the first and last measurements of the number of individuals with CI and the number of current CI in the intervention and control groups
Time Frame: 1,5 month
|
In the intervention group, the number of individuals with current CI was six during the pre-assessment.
|
1,5 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: NESLİHAN İSTEK, https://www.selcuk.edu.tr/
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Ulcer
- Behavior
- Skin and Connective Tissue Diseases
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Adherence Interventions
- Medication Adherence
- Pressure Ulcer
- Health Education
- Socioeconomic Factors
- Population Characteristics
- Educational Status
Other Study ID Numbers
- SelcukUNeslihanİSTEK.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wheelchair Users
-
VA Pittsburgh Healthcare SystemCompleted
-
Momentum Wheels for HumanityUniversity of Pittsburgh; Universidad de El Salvador; Google LLC.Completed
-
VA Pittsburgh Healthcare SystemCompleted
-
Nova Scotia Health AuthorityTerminated
-
VA Pittsburgh Healthcare SystemUniversity of PittsburghCompleted
-
University of ManitobaCompletedOlder Adult Manual Wheelchair UsersCanada
-
University of Alabama at BirminghamEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingCardiometabolic Risk Factors in Adult Wheelchair UsersUnited States
-
Université de Reims Champagne-ArdenneNot yet recruiting
-
Karabuk UniversityCompletedDisability | Athletic Performance | Wheelchair Users | Disabled PersonsTurkey
-
VA Pittsburgh Healthcare SystemCompletedWheelchair UsersUnited States
Clinical Trials on education
-
Erzincan UniversityCompletedQuality of Life | Nursing Caries | Breastfeeding | Postpartum | Nursing Model | Levine Conservation Model
-
Oregon Health and Science UniversityEnrolling by invitation
-
Mexican National Institute of Public HealthUniversity of North Carolina, Chapel Hill; Danone ResearchCompleted
-
Mclean HospitalCompleted
-
University of South FloridaNational Cancer Institute (NCI)WithdrawnPediatric CancerUnited States
-
University of TartuRecruiting
-
Jen-Ai Hospital Institutional Review BoardEnrolling by invitation
-
US Department of Veterans AffairsThe American Legion Department of WisconsinCompletedCoronary Artery Disease | Hypertension | Diabetes Mellitus | HyperlipidemiaUnited States
-
Simon Fraser UniversityNatural Sciences and Engineering Research Council, CanadaNot yet recruiting
-
University of Social Sciences and Humanities, WarsawNational Science Centre, PolandRecruiting