NCT05959876

Brief Summary

The aim of this randomized controlled study, which includes pre-test and post-test, is to examine the perineum care education given to caregivers of patients with incontinence and being treated in a palliative care clinic. The basic question it aims to answer is: Does the perineum care training given to the relatives of patients treated in the palliative care clinic have an effect on the level of knowledge about perineum care? Participants will participate in a training activity on perineum care. Researchers will compare whether perineum care training given to relatives of palliative care patients is effective compared to the routine service operation, by using 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
84

participants targeted

Target at 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 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

July 18, 2023

Last Update Submit

July 29, 2023

Conditions

Keywords

Perineum CareCaregiver EducationPalliative Care

Outcome Measures

Primary Outcomes (1)

  • Palliative care patient relatives' perineum care information: First test

    "Perineum Care Knowledge Test" is a test prepared by researchers in line with the literature and sent to an expert academician to ensure content validity. The Perineum Care Knowledge Test is a 3-likert-type questionnaire consisting of a total of 15 questions coded as true, false, I don't know. The minimum score to be obtained from the test is 0 and the maximum score is 15. A high score at the end of the evaluation indicates that the relatives of the patients have a high level of knowledge about perineal care, while a low score indicates a low level of knowledge.

    Just before training

Secondary Outcomes (1)

  • Perineal care information of palliative care patient relatives: Second test

    Immediately after training

Study Arms (2)

Training group

EXPERIMENTAL

Face-to-face perineal care training will be given to the relatives of the patients in the training group in the determined common time period. During the trainings, the presentation prepared in the power point program and the content of perineum care will be conveyed by the researcher in two 30-minute sessions using plain lecture, case study and question and answer techniques.

Other: Training group

Control group

ACTIVE COMPARATOR

The participants in the control group will not be interfered with by the researcher during the research.

Other: Control group

Interventions

Face-to-face perineal care 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:

  • Who agreed to participate in the study
  • Hhose mother tongue is Turkish,
  • years old 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

MeSH Terms

Interventions

Sensitivity Training GroupsControl Groups

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic 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 Nurse

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 25, 2023

Study Start

August 15, 2023

Primary Completion

September 15, 2023

Study Completion

October 15, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

No IPD will be shared with other researchers.