Actively Recruiting
The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation: A Randomised Controlled Trial
Led by Kocaeli University · Updated on 2026-02-11
58
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Many patients experience high anxiety before surgery, especially those undergoing stoma surgery due to fears about anesthesia, lifestyle changes, and potential complications. This trial aims to assess how preoperative stoma simulation affects anxiety levels before surgery and adaptation to the stoma afterward. The study addresses concerns about insufficient pre-surgery information and the impact of anxiety on recovery and compliance with stoma care. Participants will be randomly assigned to either a stoma simulation group or a control group. The simulation group will experience wearing a stoma bag adapter with stoma paste and a bag filled with tissues and water for 24 hours before surgery to familiarize themselves with stoma life. Both groups will have their anxiety measured before surgery and their stoma adaptation assessed at discharge and one month post-surgery using standardized tools. Participants will be informed about the study a day before surgery and complete anxiety inventories. Anxiety will be measured 24 hours and 30 minutes before surgery. Stoma adaptation will be evaluated at discharge (about 7 days post-surgery) and one month later using the Ostomy Adjustment Inventory. The study is single-blinded and conducted by Kocaeli University, with follow-up lasting one month after surgery.
CONDITIONS
Brief Title
The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients who are planned for elective stoma surgery
- Are between the ages of 18-65
- Can speak Turkish
- Can read and write
- Are conscious
- Are willing to participate in the study
You will not qualify if you...
- Patients with speech or hearing impairments
- Those who have had urostomy surgery
- Those who have a psychological diagnosis or are taking medication
- Those who need intensive care after surgery
- Those whose stoma was closed during the study
- Those who have complications in the peristomal area
- Patients who have had stoma surgery before
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 hours before surgery
Participants in the experimental group experience a stoma simulation 24 hours before surgery to help reduce anxiety and prepare for the stoma.
1 visit (in-person)
Duration - Surgery day and up to discharge (approximately 7 days)
Participants undergo elective stoma surgery followed by immediate post-operative care including evaluation during discharge.
1 visit for surgery and 1 visit at discharge
Duration - 1 to 3 months after surgery
Participants are followed up to assess adaptation to the stoma using the Ostomy Adjustment Inventory at 1 month or 3 months after surgery depending on the group.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Istanbul University Istanbul Medical Faculty Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
H
Hatice Merve Alptekin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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