NCT06775171

Brief Summary

It is known that caregivers of patients at high risk of developing pressure injury (PBI) have important responsibilities and education to be given to caregivers is necessary for the prevention of PBI. This study was planned to determine the effect of video-assisted training to be given to caregivers of patients at high risk of developing BP on caregivers' knowledge level, attitudes, behaviors and reactions towards caregiving. The research will be conducted as a randomized controlled experimental study in Gaziantep City Hospital inpatient units between 15.09.2023-15.09.2025. A total of 270 patients will be included in the study, with 90 patients assigned to each of the video training group, standard training group and control group. Criterion sampling method will be used to assign the participants to the experimental and control groups, and those with medium and high Braden Pressure Ulcer Risk Assessment Scale scores will be determined and randomly assigned to the groups. Sociodemographic Characteristics Form, Braden Pressure Ulcer Risk Assessment Scale, Family Caregivers' Knowledge, Attitude and Practice Assessment Tool for Pressure Injury Prevention and Caregiver Reaction Assessment Scale will be used for data collection. Data will be collected by face-to-face interviews in inpatient units after randomization. Participants in the video training group will be shown training videos on prevention of SCI, while the standard training group will receive a verbal training and the control group will follow routine clinical protocols. They will be asked to watch the video trainings at least three times in any time and environment they want for four weeks and their weekly feedback will be collected. Final measurements of all participants will be made at the end of the fourth week. In the statistical analysis of the data, descriptive statistics, t test, ANOVA, ANCOVA, Mann Withney U, Kruskall Wallis H test and Wilcoxon signed-rank test will be used according to normal distribution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 14, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

August 29, 2024

Last Update Submit

December 10, 2025

Conditions

Keywords

CaregiverCaregiving BehaviorCaregiving ResponseCaregiving AttitudePressure InjuryVideo Training

Outcome Measures

Primary Outcomes (1)

  • Caregiver Knowledge Level

    Changes in caregiver knowledge about pressure injuries following the video-assisted training.

    a mounth

Secondary Outcomes (1)

  • Attitudes Towards Caregiving-Caregiver Behaviors-Caregiver Responses

    a mounth

Other Outcomes (1)

  • Braden Pressure Ulcer Risk Assessment Scale Score-Video Viewing Frequency and Feedback

    a mounth

Study Arms (3)

video training group

EXPERIMENTAL

Caregiving knowledge, attitudes, behaviors and caregiving reactions will be measured in the pre-test. Then, the participants will be given training cards containing the QR codes of the videos previously created by the researcher, they will be asked to watch them at least three times at any time and environment they want for four weeks, and weekly feedback will be received. As a post-test, knowledge level, attitude, behavior and caregiving reactions will be measured at the end of the fourth week.

Behavioral: video training group

standard education group

EXPERIMENTAL

Caregiving knowledge, attitudes, behaviors and caregiving reactions will be measured in the pre-test. Afterwards, a verbal training will be given for twenty minutes using the training booklet prepared by the researcher in advance for the prevention of caregiving. As a post-test, knowledge, attitude, behavior and caregiving reactions will be measured face-to-face at the end of the fourth week.

Behavioral: video training group

control group

NO INTERVENTION

The control group will not receive any training and measurements will be made simultaneously with the experimental groups. In the pre-test, caregiving knowledge level, attitude, behavior and caregiving reactions will be measured. As a post-test, knowledge level, attitude, behavior and caregiving reactions will be measured face to face at the end of the fourth week.

Interventions

Creation of the Education Booklet While creating the education booklet that includes the definition of BY, the areas where it frequently develops, risk factors, classification, prevention and situations where it requires professional support, it will be created by the researcher by scanning the current literature and taking the opinions of the Faculty Members from the Nursing Fundamentals field in terms of scope, comprehensibility and scientific content. Creation of Videos The videos will be prepared in five separate videos that will include the definition of BY, the areas where it frequently develops, risk factors, classification, prevention and situations where it requires professional support in line with the education booklet. QR codes of the prepared videos will be created. Each video will be planned to be 5-10 minutes. The videos will be checked by the Advisor Faculty Member and corrections will be made in line with his/her suggestions.

Also known as: standard education group, control group
standard education groupvideo training group

Eligibility Criteria

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

You may qualify if:

  • Being 18 years of age or older,
  • Agreeing to participate in the study,
  • Being literate,
  • Being able to communicate verbally,
  • Having a device (tablet, smartphone or computer) that can watch videos,
  • Being able to provide care to a patient with a moderate or high Braden Pressure Ulcer Risk Assessment Scale score.

You may not qualify if:

  • Refusing to participate in the study,
  • Providing care to a patient with a low Braden Pressure Ulcer Risk Assessment Scale score.
  • Not watching all of the videos,
  • Not completing the four-week training period,
  • Requesting to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş İstiklal Üniversitesi

Kahramanmaraş, Oniksubat, 46000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 29, 2024

First Posted

January 14, 2025

Study Start

January 14, 2024

Primary Completion

December 14, 2024

Study Completion

November 3, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations