The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-01-02

Study Completion Date

2028-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Stoma Prehabilitation on Stoma Patients

NCT04692610

Stoma Anxiety Depression +1 more

COMPLETED NA

Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients

NCT04326335

Ostomy

UNKNOWN NA

Communication Intervention for Fecal Ostomy Surgery

NCT06320002

Surgery Colostomy Stoma Ileostomy - Stoma

COMPLETED NA

The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma

NCT05601024

Stoma Colostomy Stoma Ileostomy

COMPLETED NA

Effects of White and Pink Noise Applied Before and During Colonoscopy on Pain and Anxiety

NCT07034638

Surgical Procedures, Elective Nurse Based Care Management

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colostomy - Stoma Ileostomy - Stoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stoma simulation group

1. Patients are informed about the study 24 hours before surgery.
2. The patient is given a "patient information form" and "The State-Trait Anxiety Inventory".
3. The stoma simulation is started.
4. The stoma simulation is ended on the morning of the surgery and the patient's state anxiety is measured.
5. During the discharge, the patient's adaptation to the stoma is evaluated using the Ostomy Adjustment Inventory.
6. 1 months after surgery, the patient's adaptation to the stoma is evaluated again using the Ostomy Adjustment Inventory.

Group Type EXPERIMENTAL

Stoma simulation

Intervention Type OTHER

Patients who will undergo stoma surgery will have an intervention one day before the surgery. The adapter will be cut to an estimated stoma size, heated by rubbing with hands and adapted to the skin by applying stoma paste. The patient will be asked to place their hand on the adapter and apply pressure. Then, the stoma bag filled with tissues and water and the adapter will be combined. The patient will be informed that they should not hesitate to do any activity that they will spend 24 hours with the stoma bag. The patient will be provided with the opportunity to go to the toilet, eat, sleep and experience all their daily activities with the stoma. It allows patients to experience the stoma bag by putting it on 24 hours before the surgery. In this way, patients know that they will not encounter any surprises after the surgery.

Control group

1. Patients are informed about the study 24 hours before the surgery.
2. The patient is given a "patient information form" and "The State-Trait Anxiety Inventory".
3. The patient's state anxiety is measured on the morning of the surgery.
4. During the discharge, the patient's adaptation to the stoma is evaluated using the Ostomy Adjustment Inventory.
5. 3 months after the surgery, the patient's adaptation to the stoma is evaluated again using the Ostomy Adjustment Inventory.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stoma simulation

Patients who will undergo stoma surgery will have an intervention one day before the surgery. The adapter will be cut to an estimated stoma size, heated by rubbing with hands and adapted to the skin by applying stoma paste. The patient will be asked to place their hand on the adapter and apply pressure. Then, the stoma bag filled with tissues and water and the adapter will be combined. The patient will be informed that they should not hesitate to do any activity that they will spend 24 hours with the stoma bag. The patient will be provided with the opportunity to go to the toilet, eat, sleep and experience all their daily activities with the stoma. It allows patients to experience the stoma bag by putting it on 24 hours before the surgery. In this way, patients know that they will not encounter any surprises after the surgery.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No