NCT05979402

Brief Summary

The purpose of this randomized controlled trial, which included pretest and posttest, was to examine the effectiveness of pressure ulcer prevention and care education given to caregivers of patients treated in a palliative care clinic. The key questions it aims to answer are:

  • Does the routine clinical training given in the palliative care clinic have an effect on the knowledge level of patients' relatives about pressure ulcers?
  • Does the pressure ulcer education given to the relatives of patients treated in the palliative care clinic have an effect on the level of knowledge about pressure ulcers? Participants will participate in an educational activity on pressure ulcers. Researchers will compare whether pressure ulcer training given to palliative care patient relatives is effective compared to routine service training with lecture, question-answer and presentation method.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable healthy

Status
unknown

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

First Submitted

Initial submission to the registry

July 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

20 days

First QC Date

July 30, 2023

Last Update Submit

August 4, 2023

Conditions

Keywords

Pressure UlcerCaregiver EducationPalliative Care

Outcome Measures

Primary Outcomes (1)

  • Pressure ulcer information of palliative care patients' relatives: First test

    "Pressure Ulcer Knowledge Test" is a test prepared by researchers in line with the literature and sent to three expert academicians to ensure content validity. Pressure Ulcer Knowledge Test is a 3-point Likert-type questionnaire consisting of 17 questions coded as true, false, I don't know. Five of the questions in the test were designed to be scored reversely and 12 of them were scored straight. The score to be taken from the test is between 0-17. A high score indicates that the relatives of the patients have a high level of knowledge about pressure ulcers, and a low score indicates a low level of knowledge.

    Just before training

Secondary Outcomes (1)

  • Pressure ulcer information of palliative care patients' relatives: Second test

    Immediately after training

Study Arms (2)

Training group

EXPERIMENTAL

Face-to-face pressure ulcer training will be given to the relatives of the patients in the training group in the determined common time period. The presentation and pressure ulcer content prepared during the trainings will be conveyed by the researcher in two 30-minute sessions using lectures, example events and question-answer techniques.

Other: Training group Face-to-face pressure ulcer training

Control group

ACTIVE COMPARATOR

Participants in the control group will not be interfered with by the researcher during the research. They will receive routine in-clinic training given by nurses.

Other: Control group

Interventions

Face-to-face presure ulcer training

Training group

No intervention

Control group

Eligibility Criteria

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

You may qualify if:

  • Those who agree to participate in the study
  • Native Turkish,
  • years and over
  • Able to read and write

You may not qualify if:

  • Who refused to participate in the study
  • Native language is not Turkish
  • Illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hancer Tok H, Uzun LN. Pressure ulcer prevention: family caregiver training effectiveness. BMJ Support Palliat Care. 2024 Dec 25;15(1):72-78. doi: 10.1136/spcare-2023-004711.

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 Officials

  • Lütfiye Nur Uzun, PhD

    Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing Department

    PRINCIPAL INVESTIGATOR
  • Hümeyra Hançer Tok, PhD

    Bolu Abant İzzet Baysal University Faculty of Health Sciences Nursing Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lütfiye Nur Uzun, PhD

CONTACT

Hümeyra Hançer Tok, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome evaluations will be conducted by a researcher blinded to group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled study with experimental and control groups consisting of pre-test and post-test
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 7, 2023

Study Start

August 10, 2023

Primary Completion

August 30, 2023

Study Completion

September 30, 2023

Last Updated

August 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

No IPD will be shared with other researchers.