The Effect of Structured Education Given to Individuals with Permanent Ostomy on Patient Outcomes

NCT ID: NCT06816602

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2026-04-30

Brief Summary

Stoma is the surgical creation of an artificial opening on the abdominal surface for the purpose of evacuation. Although stomas are created to help individuals return to a healthy and productive life, to maintain a better quality and longer life and to improve the underlying pathology, they significantly affect the physical, mental, emotional and social life of patients. Stoma is also considered to be a very difficult situation to accept because it causes physical changes in individuals. Therefore, it causes problems in body image, sexual life and self-confidence that are difficult to cope with. In addition to these problems, changes in physical appearance and physiological problems as a result of stoma opening negatively affect the body image perception of the individual, cause him/her to see himself/herself different from others, feel ashamed of himself/herself, decrease self-esteem and self-confidence, feel fear of rejection by family and friends and limit social activities. Psychological disorders such as obsession, denial and imaginary rectum sensation are also seen in this period, and the patient may react with anger, anxiety, depression and isolation. In short, stoma negatively affects the quality of life and all physical, psychological, spiritual and social aspects of the individual. In a multicentre study, it was found that all aspects of quality of life of individuals had a decreasing score after stoma surgery. In a systematic review, it was shown that quality of life decreased after stoma formation for both cancer and non-cancerous reasons. Education and counselling interventions are very important for this. In a study, it was reported that telephone counselling had a positive effect on patients in order to prevent their concerns about sexual life and the difficulties they experienced with their stoma. However, there is no study in the literature that provides face-to-face structured training to individuals with permanent ostomy and monitors the effect of this training on body image, sexual satisfaction and quality of life. The aim of this study is to provide face-to-face structured education to patients with ostomy and to examine the effect of this education on body image, sexual satisfaction and quality of life.

Detailed Description

According to the data obtained from researches and associations in the USA, approximately 725,000-1,000,000 individuals are thought to have stoma today and this number is increasing day by day. In the United States, between 120,000-150,000 new stomas are opened every year. In Turkey, this number was reported to be 2509 individuals in the statistics made in 2017. Although stoma is applied to prolong the life span of patients, to help them return to the living standards they had before diagnosis, to improve their quality of life and to improve the underlying pathology, it causes them to encounter problems that cause changes in lifestyle in physical, emotional, sexual, psychological and social aspects. Studies have shown that the quality of life of individuals after stoma surgery has a decreasing score in all aspects and in another study, it was reported that telephone counselling had a positive effect on patients to prevent their concerns about sexual life and the difficulties they experienced with their stoma. The uniqueness of this study is that face-to-face structured training was given to patients with permanent ostomy and the effect on body image, sexual satisfaction and quality of life of individuals in the first and third months was examined.

Conditions

Ostomy - Ileostomy or Colostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control group

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

Education

Group Type: EXPERIMENTAL

education

Intervention Type: BEHAVIORAL

Receiving structured education

Interventions

education

Receiving structured education

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: Over 18 years old, with a permanent ostomy, with ileostomy or colostomy, no cognitive or mental problems Exclusion Criteria: Previous structured training on living with a stoma, those with psychiatric or mental problems, those undergoing revision surgery

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Özge İşeri

OTHER

Sponsor Role: lead

Responsible Party

Özge İşeri

Assistant Professor, Ondokuz Mayıs University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ondokuz Mayıs Unıversity

Samsun, Atakum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Özge İşeri Özge İşeri, Assistant Professor, PhD

Role: CONTACT

ozgepekiniseri@gmail.com

03623121919

Ayşe Arslanoğlu Yaşar Postgraduate master student, RN

Role: CONTACT

ayse.arslanoglu121@gmail.com

5417413355

Facility Contacts

Özge İşeri Ondokuz Mayıs Unıversıty, PhD

Role: primary

ozgepekiniseri@gmail.com

Other Identifiers

Ondokuz Mayıs University

Identifier Type: OTHER

Identifier Source: secondary_id

OMU 2024/450

Identifier Type: -

Identifier Source: org_study_id