Vıdeo-Assısted Stoma Care Traınıng Gıven To Patıents Wıth Stoma Adaptıng To Stoma and Complıcatıons

November 1, 2024 updated by: Senem GÜNEŞ KARA, Hatay Training and Research Hospital

Effect of Video-Assisted Stoma Care Education Given to Patients With Stoma on Postoperative Anxiety, Adapting to Stoma and Complications: A Randomized Controlled Trial

Objective: The aim of this study is to evaluate the effects of video-assisted stoma care training given to patients with stoma on postoperative anxiety, stoma compliance and complications.

Materials and Methods: This study was conducted as a double-blind randomized controlled interventional study within the scope of a doctoral thesis between January 2021 and September 2022 at the General Surgery Clinics of Aydın Atatürk State Hospital, Aydın State Hospital and Aydın Adnan Menderes University Practice and Research Hospital with 42 patients, 21 in the intervention group (who received video-assisted stoma care training in the postoperative period) and 21 in the control group, who met the sampling criteria. In the postoperative period, patients in the intervention group were given video-assisted stoma care training, while patients in the control group were given training using plain narration and demonstration methods. During the research process, patients were visited at 3 different time periods to determine the patients' anxiety levels, evaluate their compliance with the stoma and complications, and the patient follow-up was concluded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Aydın, Merkez, Turkey, 48000
        • Adnan Menderes University Health Sciences Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a stoma
  • Being over 18 years old
  • Having no complications from the stoma

Exclusion Criteria:

  • Having developed any complications in the stoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Group receiving standard stoma care training + video-supported training
Other: video-supported training
Patients with stomas were provided with video-supported training in addition to standard stoma care training.
No Intervention: control group
Group receiving standard stoma care training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Scale
Time Frame: Pre-training 1 day and Post-training 1 day
The State Anxiety Inventory (STAI-I) was developed by Spielberger in 1970 and its Turkish form was adapted by Öner N. et al. for validity and reliability studies. While the anxiety level is scored as "(1) never, (2) a little, (3) a lot, and (4) completely" in the STAI-I, the options in the Trait Anxiety Inventory (STAI-II) are (1) almost never, (2) sometimes, (3) a lot, and (4) almost always. The scales include "straight" and reversed statements.
Pre-training 1 day and Post-training 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adaptation Scale for Individuals with Stoma
Time Frame: 1 day Pre-training and Post-training 1 day
It is a 23-item self-assessment scale developed by Simmons et al. (2009) to determine the adaptation level of individuals with ostomy to ostomy. Its validity and reliability for Turkish was performed by Karadağ et al. (2011). Ostomy Adaptation Scale consists of 4 subdimensions including acceptance (items 1, 3, 4, 6, 9, 14, 15, 19, 23), anxiety/concern (items 12, 13, 17, 20, 21), social adaptation (items 5, 7, 8, 11) and anger (items 2 and 10). In addition, 3 items (16, 18 and 22) were not included in any subdimension. Each item in the scale is evaluated on a 5-point Likert-type scale with 0-4 points (Strongly agree, Agree, Not sure, Disagree, Strongly disagree).
1 day Pre-training and Post-training 1 day
Pittman Ostomy Complication Severity Index
Time Frame: Post-training 1 week
Pittman Ostomy Complication Severity Index (OCSI) was developed by Joyce Pittman in 2014 to assess the frequency and severity of complications developing in the early postoperative period during the follow-up period (30 days after the operation) of individuals with stoma. Its validity and reliability in Turkish were performed by Arslantaş and Karahan (2019). OCSI was found to have content validity index (CVI = 0.9), number of items (k = 0.71-1.0), and significance between the items and the total score (ICC = 0.991, P ≤ .001). The OCSI format includes a Likert-like scale with nine individual items ranging from 0 to 3 points (minimum 0, maximum 27) and a total score calculated by summing the individual items. 0 indicates that the complication is not present, and 3 indicates that the complication is severe. The complication items considered are; discharge, peristomal irritant dermatitis, pain, bleeding, stomal necrosis, stomal stenosis, retraction, mucocutaneous separation and hyperplasi
Post-training 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hatay Training and Research Hospital

Investigators

  • Study Chair: Senem GÜNEŞ KARA, Ph.D, Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Actual)

September 10, 2022

Study Completion (Actual)

September 10, 2022

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Estimated)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Hatay Training

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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