Wheelchair UsersNCT07438899
The Effect of Pressure Injury Training on Knowledge Levels and Wound Prevention in Wheelchair Users
A study testing education in people with Wheelchair Users and Pressure Ulcer Prevention, run by Selcuk University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wheelchair Users, Pressure Ulcer Prevention, Pressure Ulcer (PU)
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Feb 2022to 25 Jul 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Wheelchair user
- No communication difficulties
- Willing to participate voluntarily in the study
- Healthy volunteer
Who cannot join
- Younger than 18 years or older than 65 years
- Presence of any communication difficulties
- Unwilling to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
selcukU
Konya, Selcuklu
Selcuk University
Konya, Selçuklu, 42130
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- education
- Keywords
- Wheelchair, Nursing interventions, Health education, Individualized counselling, Pressure injury, Prevention
- Medical subject headings
- Pressure Ulcer, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
Also called Online Pressure Injury Prevention Education, Pressure Injury Prevention Counseling, Pressure Injury Follow-up
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: education |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3,5 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1,5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start10 Feb 2022
- Primary completion24 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wheelchair UsersStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Neslihan Istek, Selcuk University
- Investigators
- NESLİHAN İSTEK, Principal investigator, https://www.selcuk.edu.tr/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438899
- Sponsor's protocol ID
- SelcukUNeslihanİSTEK.01
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Training Given to Wheelchair Users on Their Level of Knowledge, Prevention of Pressure Injury and Wound Healing
- ClinicalTrials.gov ID
- NCT07438899
- Acronym / sponsor ID
- SelcukUNeslihanİSTEK.01
- Keywords
- Wheelchair, Nursing interventions, Health education, Individualized counselling, Pressure injury, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 27 Feb 2026 (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.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| education, monitoring and counseling | Experimental | Behavioral: educationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 65 years
- Wheelchair user
- No communication difficulties
- Willing to participate voluntarily in the study
- Healthy volunteer
Key exclusion criteria (3 listed)
- Younger than 18 years or older than 65 years
- Presence of any communication difficulties
- Unwilling to participate in the study
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 |
|---|---|---|
| educationAlso: Online Pressure Injury Prevention Education, Pressure Injury Prevention Counseling, Pressure Injury Follow-upTo 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. | Behavioural | education, monitoring and counseling |
Primary outcome
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 secondary outcomes
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
Statistical comparison of Pressure Ulcer Healing Assessment Scale (PRS) scores between the experimental and control groups
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Wound Ostomy Incontinence Nurses AssociationLink provided by the sponsor.
- ULUSAL TEZ MERKEZİ (YÖKTEZ)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
NESLİHAN İSTEK principal investigator
https://www.selcuk.edu.tr/
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Wheelchair Users and Pressure Ulcer Prevention, run by Selcuk University at 2 sites in Turkey (Türkiye).
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.