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

February 3, 2025 updated by: Özge İşeri
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Atakum
      • Samsun, Atakum, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Control
Experimental: Experimental group
Education
Behavioral: education
Receiving structured education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
body image
Time Frame: pretest, 1 month after intervention, 3 month after intervention
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
Time Frame: pretest, 1 month after intervention, 3 month after intervention
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
Time Frame: pretest, 1 month after intervention, 3 month after intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Özge İşeri

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OMU 2024/450
  • Ondokuz Mayıs University (Other Identifier: Ondokuz Mayıs University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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