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

Not Applicable

Completed

• Conditions: Stoma - Ileostomy; Stoma Colostomy; Stoma; Education of Patients

• Registration Number: NCT06672211
• Lead Sponsor: Hatay Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-10
• Primary Completion: 2022-09-10
• Study Completion: 2022-09-10
• Study First Submitted: 2024-10-21
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-01
• Last Update Submitted: 2024-11-01
• Study First Posted: 2024-11-04
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Scale	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.

Secondary Outcome Measures

Name	Time	Method
Adaptation Scale for Individuals with Stoma	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).
Pittman Ostomy Complication Severity Index	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

Trial Locations

Locations (1)

Adnan Menderes University Health Sciences Institute; 🇹🇷 Aydın, Merkez, Turkey