NCT06213441

Brief Summary

This study was planned as a randomized controlled trial to determine the effect of stoma care training given by the Pecha Kucha method to improve the quality of life and self-sufficiency of individuals with stoma.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

December 27, 2023

Last Update Submit

September 26, 2025

Conditions

Keywords

educationostomycareQuality of LifeSelf-sufficiency

Outcome Measures

Primary Outcomes (2)

  • LIFE QUALITY

    Quality of life with stoma may change with pecha kucha training. Stoma Quality of Life Scale was developed by Baxter et al., (2006) in 2006, and its Turkish validity and reliability study was conducted by Karadağ et al. in 2011. (2011) is a 19-item scale. The scale includes "Work and Social Life" (questions 3, 4, 5, 6, 18 and 19), "Sexual Life and Body Image" (questions 7, 8, 9, 12 and 15) and "Stoma Functions" (questions 10). It has three sub-dimensions: questions 11, 13, 14, 16 and 17). The first 2 questions of the scale are answered with a rating consisting of numbers between 0 and 100, which includes general satisfaction evaluation (0: complete dissatisfaction, 100: complete satisfaction).

    4 weeks later

  • STOM SELF-EFFICIENCY

    patients self-efficacy with stoma may change with pecha kucha training. Stoma Self-Efficacy Scale was developed by Bekkers et al., (1996) in 1996, and its Turkish validity and reliability study was published by Karaçay et al. in 2020. (2020) is a 22-item 5-point Likert type scale with 1 (I definitely do not trust), 2 (I have some confidence), 3 (I have sufficient confidence), 4 (I have a lot of confidence), 5 (I definitely trust). The scale has two subscales: Stoma Care Self-efficacy (1-13 items) and Social Self-efficacy (14-22 items). The scale is evaluated based on the total score. The lowest score that can be obtained from the scale is 22, the highest score is 110, and higher scores indicate better self-efficacy levels. Cronbach's alpha number of the scale was calculated as 0.95.

    4 weeks later

Study Arms (2)

arm trained with pecha kucha

EXPERIMENTAL

The interventions to be applied to the experimental arm were as follows: a descriptive characteristics form was administered to the patient before discharge from the clinic. The PC education presentation was shown to the patient via mobile phone before leaving the clinic and was also shared via WhatsApp using the phone numbers they used. The PC education presentation lasted approximately 5-7 minutes. Four weeks after the training, the Stoma Quality of Life Scale and the Stoma Self-Efficacy Scale were completed via an online survey.

Other: pecha kucha education

control arm

NO INTERVENTION

TInterventions to be applied to the control arm: A descriptive characteristics form was administered to the patient before discharge from the clinic. Routine training was provided by the wound and stoma care nurse before discharge. Four weeks after discharge, the patient was administered the Stoma Quality of Life Scale and the Stoma Self-Efficacy Scale via an online survey. The study's implementation plan is outlined in Figure 1.

Interventions

Pecha kucha training to be given to the experimental arm will be given by the researcher. The training content will be created in line with the literature and will be given before the patient is discharged.

arm trained with pecha kucha

Eligibility Criteria

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

You may qualify if:

  • Having a stoma for the first time,
  • Can speak Turkish,
  • Can understand Turkish,

You may not qualify if:

  • A stoma has been opened before,
  • Having difficulty in speaking Turkish
  • Having difficulty in understanding Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray University

Aksaray, Turkey (Türkiye)

RECRUITING

Study Officials

  • MAİDE YEŞİLYURT

    Aksaray University

    STUDY DIRECTOR

Central Study Contacts

MAİDE YEŞİLYURT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: prospective randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 19, 2024

Study Start

December 23, 2023

Primary Completion

September 28, 2025

Study Completion

September 29, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

study protocol

Shared Documents
STUDY PROTOCOL
Time Frame
4 weeks later
Access Criteria
after the work is completed

Locations