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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06672211
Enrollment
42
Registered
2024-11-04
Start date
2021-01-10
Completion date
2022-09-10
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Education of Patients, Stoma, Stoma Colostomy, Stoma - Ileostomy

Keywords

stoma, İleostomi, Colostomy, Education of Patients

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.

Interventions

OTHERvideo-supported training

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

Sponsors

Hatay Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
State-Trait Anxiety ScalePre-training 1 day and Post-training 1 dayThe 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

MeasureTime frameDescription
Adaptation Scale for Individuals with Stoma1 day Pre-training and Post-training 1 dayIt 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 IndexPost-training 1 weekPittman 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026