Evaluation of the Effect of Two Different Methods on Stoma Compliance and Self-efficacy

Sponsor
Acibadem University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05308693
Collaborator
(none)
78
1
2
10
7.8

Study Details

Study Description

Brief Summary

In patients with stoma, apart from traditional methods, different methods whşch can be used in visual, auditory and motor skills are recommended as a part of education methods regarding stoma care.

The aim of this study is to evaluate the effects of two different methods in teaching stoma care skills considering patients with colostomy/ileostomy on stoma compliance and self-efficacy levels. This research is the thesis study designed within the scope of the Surgical Diseases Nursing Master's program.

Condition or Disease Intervention/Treatment Phase
  • Other: Education material - Patient Compatible Stoma Educational Material
N/A

Detailed Description

Stoma is the opening of the intestine to the abdominal wall. In recent years, the number of individuals with ostomy has been increasing, and it is stated that there are 800,000 individuals in North America alone and approximately 15,000 in Hong Kong.. As a result of this surgical procedure, regardless of ileostomy or colostomy, the daily life of individuals who went through this procedure has been affected in terms of not only the way their bodies excretes but also way of their eating habits, sexual life, self-esteem, religious/cultural needs, social life, sense of independence, self-care and the rest of their daily life.. Gaining patients' self-care activities related to stoma care begins in the preoperative period.

The self-care and development of activities in patients with stoma consists of cognitive, emotional, and psychomotor learning processes.

Patients need to acquire the necessary knowledge and skills to meet their new care needs. This learning process is based on the nurse's practical experience and teaching methods.. After the surgery of individuals with stoma; these individuals need training and counseling in order to manage the stoma functionally and to adapt a life with a stoma in psychological terms. Wound ostomy incontinence nurses; are an unique source of information when it comes to educating the individuals who have stoma.. The American Society of Colon and Rectal Surgeons recommends preoperative stoma training. In the post-operative period after a proper training given to individuals with stoma; It is stated that reduces stoma-related complications, shortens hospital stay, and reduces the cost of stoma care. In the literature, it is stated that the stoma training performed before the surgery shortens the discharge time, reduces the cost and improves the adequacy of the individuals.. The environment, duration, patient's readiness level, past knowledge and experience of patient, education method to be used, education content and material have an important place in patient training. The language of instruction should be plain and simple.. Today, in patient training, verbal information is provided by giving written materials or showing the care practices on the patient after the surgery. While increasing the permanence and effectiveness of the materials used with the developing technology, educational content such as brochures, models, booklets, question-answers, videos and slides also provide good results. However, since the socio demographic characteristics and learning styles of the patients are different from each other, the desired permanence may not be fully achieved. Since stoma care is frequently encountered in nursing practices, is of vital importance, and affects the quality of health care of the individual, family and society, overall it is expected that the permanence of education in this practice will be increased using audio-visual and motor skills, behavior change and self-efficacy will be improved considering the increasing compliance situation in patients with stoma.. Pouresmail et al. (2019) shows that the use of simulation to learn ostomy self-care improves self-efficacy in patients.. In the literature, studies on the subject are limited, and the aim of this study is to determine the effects of two different methods in stoma care education on stoma compliance and self-efficacy levels of patient

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlledRandomized controlled
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Effect of Two Different Methods in Teaching Stoma Care Skills in Patients With Stoma on Stoma Compliance and Self-efficacy Level of Patients
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control-Classical patient education

Before the operation, the stoma area is marked, the patient is educated with the classical method brochure

Experimental: Experimental-Patient Compatible Stoma Educational Material

The stoma area is marked before the operation; A brochure is given to the patient. Practical training is given on the patient's own body with patient-compatible stoma training material.

Other: Education material - Patient Compatible Stoma Educational Material
It is an educational material made of rubber, similar to a stoma, that can be placed on the patient.

Outcome Measures

Primary Outcome Measures

  1. State Anxiety Level [after surgery, post-operative 1. day (first stoma care)]

    State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/ she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level

Secondary Outcome Measures

  1. Stoma Self-Efficacy Scale [The scale is filled in 3 times; 3 days after the surgery (post-operative 3. day) in hospital (1), and at the 3rd week after surgery (post-operative 21. day) at home by telephone (2) and 9th week after surgery (post-operative 63. day) (3) at home by phone]

    In order to determine the self-efficacy levels of individuals with stoma, the psychometric properties of the scale were examined in English, Knippenberg, Van Berge-Henegouwen in 1996. Turkish validity and reliability of the scale Karaçay et al. Adapted by (2020). The scale consists of 22 items. The scale, which is graded in a five-point Likert type, consists of two sub-dimensions. Sub-dimensions; Stoma Care is Self-Efficacy and Social Self-Efficac. The possible score on the scale ranges from 22 to 110. The higher the score, the better the level of self-efficacy

Other Outcome Measures

  1. Adjustment Scale for Individuals with Ostomy [The scale is filled in 3 times; 3 days after the surgery (post-operative 3. day) in hospital (1), and at the 3rd week after surgery (post-operative 21. day) at home by telephone (2) and 9th week after surgery (post-operative 63. day) (3) at home by phone]

    It is a self-assessment scale consisting of 23 items developed by Simmsons, Smith, and Maekawa to determine the compliance of individuals with stoma. Adjustment Scale for Individuals with Ostomy Karadağ et al. (2011), adapted into Turkish. The scale, which is graded in a five-point Likert type, has four sub-dimensions. These four dimensions are anger, social adaptation, anxiety/worry and acceptance. While the lowest score on the scale is '0', the highest score is '92'.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult patients aged 18-85 years

  • Patients who have a colostomy or ileostomy for any reason (cancer, ulcerative colitis, chron, hernia, etc.)

  • Patients who can speak and understand Turkish and do not have a psychological or neurological disease (Advanced Parkinson's, Alzheimer's, Depression, etc.)

Exclusion Criteria:
  • Patients with visual and hearing impairment

  • Patients that are unable to use their hands and upper extremities (hemiplegic, paraplegic, etc.)

  • Patients who requires a revision surgery after surgery

  • Patients whose temporary stoma was closed while in the data collection process

  • Patients with postoperative complications and prolonged discharge period (evisceration, bleeding, perforation, etc.) will be excluded from the sample.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yasemin Uslu İstanbul Ataşehir Turkey 34752

Sponsors and Collaborators

  • Acibadem University

Investigators

  • Study Director: Yasemin Uslu, Acıbadem Mehmet Ali Aydınlar Üniversitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Acibadem University, Asisst. Prof., Acibadem University
ClinicalTrials.gov Identifier:
NCT05308693
Other Study ID Numbers:
  • ATADEK 2021-13/04
First Posted:
Apr 4, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Acibadem University, Asisst. Prof., Acibadem University

Study Results

No Results Posted as of Apr 4, 2022