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

NCT06816602 | Not Yet Recruiting

• 2 other identifiers: OMU 2024/450Ondokuz Mayıs University
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Ostomy - Ileostomy or Colostomy

Keywords

ostomy; education; body image; sexual satisfaction; quality of life

Outcome Measures

Primary Outcomes (3)

• body image

  Body Image Scale; It was developed by Hopwood (2001) and adapted to Turkish by Karayurt et al. (2015). The scale consists of 10 questions that question patients' perceptions of their individual body image and their reactions to change. A low scale score indicates that the perception of self-image is better. Cronbach Alpha value in the Turkish version of the scale is 0.94. Item-Total Score Correlation Coefficients vary between 0.75 and 0.91.

  pretest, 1 month after intervention, 3 month after intervention

• Sexual Satisfaction

  Golombuk-Rust Sexual Satisfaction Scale: Golombuk-Rust (Rust and Golombok 1986) sexual satisfaction scale is a scale used to evaluate sexual problems and their severity consisting of 28 questions. It consists of 12 sub-assessment scales related to empotence, premature ejaculation, orgasm disorder, vaginismus, miscommunication, frequency and male and female avoidance, male and female insensitivity and male and female dissatisfaction. Scores of five and above indicate impairment in sexual functions in that sub-dimension. Tuğrul et al. (1993) reported that the Golombuk-Rust Sexual Satisfaction Scale is valid and reliable in our country.

  pretest, 1 month after intervention, 3 month after intervention

• Quality of Life

  Quality of Life Scale for Individuals with Ostomy (QoLQS): It was developed by Baxter et al. (2006). The scale, which evaluates the quality of life of individuals with stoma, was translated into Turkish by Karadağ et al. in 2011. It was found that the Stoma Quality of Life Scale, which consisted of a total of 19 items and 3 subscales, was valid and reliable for adult individuals with stoma (ileostomy, colostomy and urostomy) in the Turkish population. The reliability coefficient of the scale (Cronbach α) was found to be 0.87 and the reliability coefficients of the subscales were 0.77, 0.72 and 0.76, respectively.

  pretest, 1 month after intervention, 3 month after intervention

Study Arms (2)

Control group

NO INTERVENTION

Control

Experimental group

EXPERIMENTAL

Education

Behavioral: education

Interventions

education BEHAVIORAL

Receiving structured education

Experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Özge İşeri: lead

Study Sites (1)

Ondokuz Mayıs Unıversity

Samsun, Atakum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Orgasm

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Özge İşeri Özge İşeri, Assistant Professor, PhD

CONTACT

03623121919; ozgepekiniseri@gmail.com

Ayşe Arslanoğlu Yaşar Postgraduate master student, RN

CONTACT

5417413355; ayse.arslanoglu121@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Ondokuz Mayıs University

Model Details: randomized controlled trial with single blinded experimental and control group

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 10, 2025
• Study Start: February 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: April 30, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)