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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06816602
Enrollment
68
Registered
2025-02-10
Start date
2025-02-15
Completion date
2026-04-30
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ostomy - Ileostomy or Colostomy

Keywords

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

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.

Interventions

BEHAVIORALeducation

Receiving structured education

Sponsors

Özge İşeri
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

randomized controlled trial with single blinded experimental and control group

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sexual Satisfactionpretest, 1 month after intervention, 3 month after interventionGolombuk-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.
body imagepretest, 1 month after intervention, 3 month after interventionBody 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.
Quality of Lifepretest, 1 month after intervention, 3 month after interventionQuality 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzge İşeri Özge İşeri, Assistant Professor, PhD
ozgepekiniseri@gmail.com03623121919
Backup ContactAyşe Arslanoğlu Yaşar Postgraduate master student, RN
ayse.arslanoglu121@gmail.com5417413355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026