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Completed

NCT Number: NCT06672211

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

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.

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Key information

Conditions

Stoma - Ileostomy Education of Patients Stoma Stoma Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adnan Menderes University Health Sciences Institute

Aydin, Merkez, 48000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video-supported training

Other

Patients with stomas were provided with video-supported training in addition to standard stoma care training.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

Sponsors and collaborators

Lead sponsor

Hatay Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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