A Randomized Controlled Trial to Assess the Impact of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation: A Study Protocol.
Hatice Merve Alptekin, Yasemin Özhanli
https://pubmed.ncbi.nlm.nih.gov/42411565/Actively Recruiting
Led by Kocaeli University · Updated on 2026-02-11
58
Participants Needed
1
Research Sites
47 weeks
Total Duration
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
The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation
H
Hatice Merve Alptekin
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Kocaeli University
Lead Sponsor
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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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Hatice Merve Alptekin, Yasemin Özhanli
https://pubmed.ncbi.nlm.nih.gov/42411565/Kocaeli University
Lead Sponsor