- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05531331
The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma
September 5, 2022 updated by: Edanur Ozkaya, Ankara University
The Effect of Education Via Video Conferencing at Home on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma
The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma.
In addition to the main purpose, it is aimed to determine whether stoma care education given via video conference at home has an effect on individuals with stoma to perform their own stoma care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews.
The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month.
Individuals with stoma in the control group received the training routinely given in the hospital.
Self-efficacy and compliance with stoma were measured at baseline and at 2 months.
The ability to care for one's own stoma was evaluated at the end of the study.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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 Locations
-
-
Denizli
-
Pamukkale, Denizli, Turkey, 06230
- Edanur Özkaya
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Opening stoma for the first time,
- Stoma opening surgery Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, 3rd Floor Surgical Oncology Clinic,
- Whether the opened stoma is a colostomy or an ileostomy,
- Able to speak and understand Turkish,
- be over 18 years old,
- Not having any mental problems that prevent them from being trained and practiced on stoma care,
- Not having an obstacle to performing stoma care on their own in terms of vision, hearing and motor skills,
- Possibility of meeting via video conference,
- He voluntarily agrees to participate in the research.
Exclusion Criteria:
- Previous stoma opening experience,
- Not being discharged within 10 days after the operation,
- Refusal to participate in the study.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews.
The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month.
|
Educational booklets are given according to the type of stoma.
The individual with the stoma was told that the researcher was always reachable by phone and could communicate if he had any problems.
The individuals with stoma in the experimental group received the training of the company representative that sells stoma materials, which is routinely given in the hospital.
After discharge, training was given by the researcher via video conference in a total of four interviews.
The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month.
A post-test was conducted at the end of the 4th training interview, which was administered via video conferencing.
|
|
No Intervention: Control Group
Individuals with stoma in the control group received the training of the company representative that sells stoma materials routinely in the hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in the self-efficacy of the experimental group according to the Stoma Self-Efficacy Scale scores at the end of the second month
Time Frame: Baseline, 2nd month
|
The Stoma Self-Efficacy Scale was developed to measure self-efficacy in individuals with stoma.
The scale was developed by Bekkers et al. (1996).
It is a 22-item scale with two sub-dimensions.
Items in this scale are in 5-point Likert type.
The first sub-dimension is the "Stoma Care Self-Efficacy" sub-dimension, which consists of the first 13 items.
The second sub-dimension is the "Social Self-Efficacy" sub-dimension consisting of the remaining nine items.
The minimum score that can be taken from the scale is 22, the maximum score is 110, and an increase in the score from the scale indicates high levels of self-efficacy.
There is no reverse scored item in the scale.
|
Baseline, 2nd month
|
|
The change in the adaptation of the experimental group according to the Ostomy Adjustment Inventory-23 scores at the end of the second month
Time Frame: Baseline, 2nd month
|
It was created by Maekawa (2000) and later this scale was arranged by Simmons et al. (2009) in the form of Ostomy Adjustment Scale-23, consisting of 23 items and 4 sub-dimensions.
OAS-23, a self-assessment scale, is a scale used to evaluate the level of adjustment in individuals with stoma.
4 sub-dimensions in this scale: accepting (includes items 1, 3, 4, 6, 9, 14, 15, 19, 23.), anxiety/worry (12, 13, 17, 20, 21 items) .),
social cohesion (includes items 5, 7, 8, 11), and anger (includes items 2 and 10).
At the same time, there are 3 items (16, 18 and 22) that are not included in any sub-dimensions.
Each item of the scale is evaluated in a 5-point Likert type.
|
Baseline, 2nd month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in the ability of individuals with stoma to care for their stoma at the end of the 2nd month
Time Frame: Baseline, 2nd month
|
After the individuals with stoma in the experimental group were trained by the researcher throughout the study, it was evaluated that they could or could not perform their own stoma care under the supervision of the researcher.
However, the status of individuals in the control group for maintaining stoma care is based on their own statements.
|
Baseline, 2nd month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Deniz HARPUTLU, PhD, RN, Ankara University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Seo HW. Effects of the frequency of ostomy management reinforcement education on self-care knowledge, self-efficacy, and ability of stoma appliance change among Korean hospitalised ostomates. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):21-28. doi: 10.1111/iwj.13047.
- Dinuzzi VP, Palomba G, Minischetti M, Amendola A, Aprea P, Luglio G, De Palma GD, Aprea G. Telemedicine in Patients With an Ostomy During the COVID-19 Pandemic: A Retrospective Observational Study. Wound Manag Prev. 2021 Jan;67(1):12-17.
- Jin Y, Ma H, Jimenez-Herrera M. Self-disgust and stigma both mediate the relationship between stoma acceptance and stoma care self-efficacy. J Adv Nurs. 2020 Oct;76(10):2547-2558. doi: 10.1111/jan.14457. Epub 2020 Jul 23.
- Krogsgaard M, Kristensen HO, Furnee EJB, Verkuijl SJ, Rama NJ, Domingos H, Maciel J, Solis-Pena A, Espin-Basany E, Hidalgo-Pujol M, Biondo S, Sjovall A, Emmertsen KJ, Thyo A, Christensen P. Life with a stoma across five European countries-a cross-sectional study on long-term rectal cancer survivors. Support Care Cancer. 2022 Nov;30(11):8969-8979. doi: 10.1007/s00520-022-07293-y. Epub 2022 Aug 5.
- Nam KH, Kim HY, Kim JH, Kang KN, Na SY, Han BH. Effects of social support and self-efficacy on the psychosocial adjustment of Korean ostomy patients. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):13-20. doi: 10.1111/iwj.13038.
- Wang QQ, Zhao J, Huo XR, Wu L, Yang LF, Li JY, Wang J. Effects of a home care mobile app on the outcomes of discharged patients with a stoma: A randomised controlled trial. J Clin Nurs. 2018 Oct;27(19-20):3592-3602. doi: 10.1111/jocn.14515. Epub 2018 Jul 10.
- Wen SL, Li J, Wang AN, Lv MM, Li HY, Lu YF, Zhang JP. Effects of transtheoretical model-based intervention on the self-management of patients with an ostomy: A randomised controlled trial. J Clin Nurs. 2019 May;28(9-10):1936-1951. doi: 10.1111/jocn.14731. Epub 2019 Feb 18.
- White T, Watts P, Morris M, Moss J. Virtual Postoperative Visits for New Ostomates. Comput Inform Nurs. 2019 Feb;37(2):73-79. doi: 10.1097/CIN.0000000000000498.
- Yan MH, Lv L, Zheng MC, Jin Y, Zhang JE. Quality of Life and Its Influencing Factors Among Chinese Patients With Permanent Colostomy in the Early Postoperative Stage: A Longitudinal Study. Cancer Nurs. 2022 Jan-Feb 01;45(1):E153-E161. doi: 10.1097/NCC.0000000000000893.
- Zhang JE, Wong FK, You LM, Zheng MC, Li Q, Zhang BY, Huang MR, Ye XM, Liang MJ, Liu JL. Effects of enterostomal nurse telephone follow-up on postoperative adjustment of discharged colostomy patients. Cancer Nurs. 2013 Nov-Dec;36(6):419-28. doi: 10.1097/NCC.0b013e31826fc8eb.
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 (Actual)
November 1, 2021
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
September 5, 2022
First Submitted That Met QC Criteria
September 5, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Actual)
September 7, 2022
Last Update Submitted That Met QC Criteria
September 5, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 56786525-050.04.04/236864
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All collected IPD will share.
IPD Sharing Time Frame
starting 1 months after publication
IPD Sharing Access Criteria
all people access
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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