Colostomy - StomaNCT06737887
The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation
A study testing Stoma simulation in people with Colostomy - Stoma and Ileostomy - Stoma, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colostomy - Stoma, Ileostomy - Stoma
- What is being tested?
- Stoma simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2027to 2 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Istanbul Medical Faculty Hospital
Istanbul
ASSOCIATE PROFESSOR, +90212 224 2618, nuray.akyuz@iuc.edu.tr
About this study
Official title: The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation: A Randomised Controlled Trial
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.
- Conditions
- Colostomy - Stoma, Ileostomy - Stoma
- Being tested
- Stoma simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoma simulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stoma simulation group | Experimental | 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. Receives: Other: Stoma simulation |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
The State-Trait Anxiety Inventory consists of two separate dimensions: state anxiety (STAI-I) and trait anxiety (STAI-II), and these dimensions aim to measure individuals' anxiety states in different contexts. The scale consists of 40 items in total; 20 items measure state anxiety and the other 20 items measure trait anxiety. Both scales are scored between 20-80, and as the score increases, the level of anxiety increases. The State-Trait Anxiety Inventory is administered 24 hours before surgery. The patient's state anxiety is measured 30 minutes before surgery.
Measured: 24 hours before surgery and 30 minutes before surgery
Secondary outcomes (1)
Stoma adaptation
The patient's adaptation to the stoma is assessed with the Ostomy Adjustment Inventory. The scale consists of 23 items and four sub-dimensions. The sub-dimensions are acceptance, anger, anxiety/worry, and social adaptation. The lowest score on the scale is 0, and the highest is 92. A high score on the scale indicates that the individual's adaptation to the stoma is high.
Measured: the morning of the patient's discharge (7th day of surgery) and 1 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start2 Jan 2027 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Merve Alptekin, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737887
- Sponsor's protocol ID
- 2023/410
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alptekin HM, Ozhanli Y. A Randomized Controlled Trial to Assess the Impact of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation: A Study Protocol. Nurs Open. 2026 Jul;13(7):e70682. doi: 10.1002/nop2.70682.
PubMed 42411565
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06737887
- Acronym / sponsor ID
- 2023/410
- Conditions
- Colostomy - Stoma, Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 2 Jan 2027 (estimated)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Jan 2028 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stoma simulation group | Experimental | Other: Stoma simulation1. 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stoma simulationPatients 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. | Other | Stoma simulation group |
Primary outcome
Anxiety
Time frame: 24 hours before surgery and 30 minutes before surgery
The State-Trait Anxiety Inventory consists of two separate dimensions: state anxiety (STAI-I) and trait anxiety (STAI-II), and these dimensions aim to measure individuals' anxiety states in different contexts. The scale consists of 40 items in total; 20 items measure state anxiety and the other 20 items measure trait anxiety. Both scales are scored between 20-80, and as the score increases, the level of anxiety increases. The State-Trait Anxiety Inventory is administered 24 hours before surgery. The patient's state anxiety is measured 30 minutes before surgery.
1 secondary outcome
Stoma adaptation
Time frame: the morning of the patient's discharge (7th day of surgery) and 1 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Derived from this study: PubMed 42411565Alptekin HM, Ozhanli Y. A Randomized Controlled Trial to Assess the Impact of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation: A Study Protocol. Nurs Open. 2026 Jul;13(7):e70682. doi: 10.1002/nop2.70682.
- Individual participant dataSharing planned: No
Related trials for Colostomy - Stoma
RecruitingObservational study
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
Parastomal Hernia, Colorectal Cancer (Diagnosis)
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
RecruitingObservational study
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Colostomy - Stoma, Ileostomy - Stoma
Active, not recruiting
Impact of Resilience Training on Quality of Life in New Ostomy Patients and Their Partners
Ileostomy - Stoma, Colostomy - Stoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stoma simulation in people with Colostomy - Stoma and Ileostomy - Stoma, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Merve Alptekin (+902623034733, merve.alptekin@kocaeli.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 24 hours before surgery and 30 minutes before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06737887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.