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| Name | Class |
|---|---|
| Gazi University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| education, monitoring and counseling | Experimental | 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. |
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| monitoring | No Intervention | Participants in the control group who used wheelchairs received training and were only monitored for the development of pressure injury for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of mean scores from the "Pressure Injury Knowledge Test for Wheelchair Users" scale between the intervention and control groups. | 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 |
| 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" | 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. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| NESLİHAN İSTEK | https://www.selcuk.edu.tr/ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| selcukU | Konya | Selcuklu | Turkey (Türkiye) | |||
| Selcuk University |
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| Label | URL |
|---|---|
| Wound Ostomy Incontinence Nurses Association | View source |
| ULUSAL TEZ MERKEZİ (YÖKTEZ) | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2026 | Jan 14, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2012 | Jan 23, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000099060 | Adherence Interventions |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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To control selection bias, the study employed randomized selection and random assignment. Seventy-nine individuals who met the inclusion criteria were included in the study. Individuals were assigned to intervention (n= 40) and control (n= 39) groups using a stratified randomization method based on age, scores on the Braden Pressure Ulcer Risk Assessment Scale (BBURD), the Pressure Injury Information Form for Wheelchair Users, and the Pressure Ulcer Healing Assessment Scale (PUSH). The study was double-blinded, with both the participant and the statistician blinded. Participants were informed that the training would be delivered in groups and sequentially to ensure blinding, and their placement in the intervention or control groups was not disclosed. During the follow-up period, 1 participant withdrew from the study and the study was completed with 78 participants.
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In the study, a double-blind design was used, with both participants and the statistician blinded. Participants were informed that training to ensure blinding would be given in groups and sequentially, and their assigned group (intervention or control) was not disclosed. Training for the control group was administered after the final test data was collected. In the statistical phase of the study, the intervention and control groups were coded with the numbers 1 and 2, respectively, to ensure statistician blinding.
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| 3,5 months |
| Statistical comparison of Pressure Ulcer Healing Assessment Scale (PRS) scores between the experimental and control groups | 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 | In the intervention group, the number of individuals with current CI was six during the pre-assessment. | 1,5 month |
| Konya |
| Selçuklu |
| 42130 |
| Turkey (Türkiye) |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |