The Impact of Education Using a Stoma Care Training Belt

NCT06391398 | Completed

• 1 other identifier: HOCengiz
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

Brief Summary

Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and ensure adaptation to the stoma. Patient education on stoma care during the preoperative period may facilitate stoma adaptation. The aim of this study is to evaluate the impact of the education provided to patients undergoing intestinal stoma creation using a Stoma Care Training Belt on stoma care skills, adaptation, anxiety, and satisfaction.

Conditions

Stoma Colostomy; Stoma Ileostomy

Keywords

Ostomy; Education of patients; Anxiety; Patient Satisfaction

Outcome Measures

Primary Outcomes (3)

• Stoma Care Skills

  Stoma Care Skill will be evaluated 4 times in total, using the Stoma Care Skill Rubric, on the day of discharge, and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control. It consists of 23 items that include stoma care process steps. For each process step, the learner's competence is scored between 0-2 (0- Insufficient, 1- Partially adequate, 2- Satisfactory). A minimum of 0 and a maximum of 46 points can be obtained from the key. The total score obtained from the key indicates the adequacy of stoma care skills.

  day of discharge and on days 5th, 15th and 30th after discharge

• Stoma compliance

  Patients' stoma compliance levels will be evaluated 4 times in total, using the Ostomy Compliance Scale-23, on the day of discharge and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control. The total score obtained from the scale varies between 20-80. A high score indicates a high level of anxiety, and a small score indicates a low level of anxiety. The scale score varies between 0-92 points. Higher scores from each scale item indicate increased compliance.

  day of discharge and on days 5th, 15th and 30th after discharge

• Anxiety

  The anxiety levels of the patients will be evaluated 5 times in total, using the State Anxiety Scale, on the day before surgery, on the day of discharge, and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control.The total score obtained from the scale varies between 20-80. A high score indicates a high level of anxiety, and a small score indicates a low level of anxiety.

  the day before surgery, day of discharge and on days 5th, 15th and 30th after discharge

Secondary Outcomes (1)

• Patient Satisfaction

  the day before surgery, day of discharge

Study Arms (2)

Stoma care belt group

EXPERIMENTAL

In addition to routine treatment and care, patients in the intervention stoma care belt group will receive education with the Stoma Care Training Belt during the preoperative period.

Behavioral: Stoma care education with the Stoma Care Training Belt

Control group

NO INTERVENTION

Patients in the control group will not undergo any additional intervention beyond routine treatment and care.

Interventions

Stoma care education with the Stoma Care Training Belt BEHAVIORAL

Stoma care education

Stoma care belt group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intestinal stoma (colostomy or ileostomy) opened for the first time,
• Those aged 18 and over, Able to speak and understand Turkish,
• Conscious, oriented and cooperative,
• Does not have a diagnosed psychiatric or psychological disease,
• There is no obstacle to stoma care, Those who have no previous stoma knowledge or training.

You may not qualify if:

• Those who do not agree to participate in the study,
• Refuses to perform stoma care in the postoperative period,
• Leaving the job voluntarily, Those who died during the work process,
• Referred from the relevant hospital during the treatment process,
• Any postoperative complications (bleeding, infection, fistula, etc.) develop,
• Data collection forms could not be completed,
• Patients who cannot be reached will be excluded.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (2)

Hatice ÖNER CENGİZ

Altındağ, Ankara, 06080, Turkey (Türkiye)

Location

Ankara University

Ankara, Ankara, 06080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mehmet YÜKSEKKAYA, PhD

  Ankara University

  STUDY CHAIR

• İlknur Münevver GÖNENÇ, PhD

  Ankara University

  STUDY CHAIR

• Ayten DEMİR, PhD

  Ankara University

  STUDY CHAIR

• Ayhan Bülent ERKEK, MD

  Ankara University

  STUDY CHAIR

• Şiyar ERSÖZ, MD

  Ankara University

  STUDY CHAIR

• Serpil UÇAR, MSc

  Ankara University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Model Details: parallel-group, randomized controlled trial will be conducted to assess the effect of the Stoma Care Training Belt on patients' stoma care skills, adaptation, anxiety, and satisfaction. A total of 170 patients, with 85 in the intervention group and 85 in the control group, will be included. All patients in the study will receive routine stoma care education as part of their standard treatment and care. In addition to routine treatment and care, patients in the intervention group will receive education with the Stoma Care Training Belt during the preoperative period.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: May 1, 2024
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)