Clinical trial NCT06737887: The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation
Official title: The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colostomy - Stoma
Ileostomy - Stoma
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The majority of patients (60-70%) develop high levels of anxiety before surgery. Surgical patients may experience feelings of anxiety due to insufficient information and counseling before surgery and potential changes in the body caused by surgery. Fears include (but are not limited to) not waking up from anesthesia, not being able to return to previous work and family life, and adaptation concerns regarding new processes after surgery. Patients with fear of complications experience preoperative anxiety four times more than other patients. Other factors affecting preoperative anxiety were determined to be waiting for a long time before surgery, not knowing what will happen during surgery, losing control of the body, not receiving sufficient social support, being exposed to medical errors, and encountering undesirable health outcomes after surgery. The changes that will occur in the body and lifestyle after stoma surgery scare patients and cause them to feel anxiety in the pre-operative period. Despite significant developments in stoma care products and the increase in the number of nurses specialized in stoma care in recent years, the majority of patients experience problems with compliance. For this reason, the compliance of stoma patients with stoma life is increasingly the subject of clinical trials and epidemiological studies. In our country, studies conducted to determine the problems experienced by stoma individuals regarding compliance with stoma and social life are limited. Nursing interventions are recommended to reduce patients' anxiety and increase their compliance with stoma after surgery. This study aims to evaluate the effect of stoma simulation performed preoperative surgery on the patient's anxiety level and postoperative stoma compliance.


Eligibility criteria: Inclusion Criteria:

* 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 will be included.

Exclusion Criteria:

* 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 will be excluded from the study.

Primary outcomes:
measure: Anxiety
timeFrame: 24 hours before surgery and 30 minutes before surgery
Secondary outcomes:
measure: Stoma adaptation
timeFrame: the morning of the patient's discharge (7th day of surgery) and 1 months after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty Hospital
Study officials:
References: