NCT07438899

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

August 14, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

WheelchairNursing interventionsHealth educationIndividualized counsellingPressure injuryPrevention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Evaluation of individuals in the intervention group's implementation of pressure injury prevention practices using the "Pressure Ulcer Healing Assessment Form"

    3,5 months

  • Statistical comparison of Pressure Ulcer Healing Assessment Scale (PRS) scores between the experimental and control groups

    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

    1,5 month

Study Arms (2)

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.

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.

Interventions

educationBEHAVIORAL

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.

Also known as: Online Pressure Injury Prevention Education, Pressure Injury Prevention Counseling, Pressure Injury Follow-up
education, monitoring and counseling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 65 years
  • Wheelchair user
  • No communication difficulties
  • Willing to participate voluntarily in the study
  • Healthy volunteer

You may not qualify if:

  • Younger than 18 years or older than 65 years
  • Presence of any communication difficulties
  • Unwilling to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

selcukU

Konya, Selcuklu, Turkey (Türkiye)

Location

Selcuk University

Konya, Selçuklu, 42130, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pressure UlcerHealth Education

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • NESLİHAN İSTEK

    https://www.selcuk.edu.tr/

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2025

First Posted

February 27, 2026

Study Start

February 10, 2022

Primary Completion

July 24, 2023

Study Completion

July 25, 2023

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations