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The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma

Primary Purpose

Stoma Ileostomy, Stoma Colostomy, Self Efficacy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
At home education via video conferencing
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stoma Ileostomy focused on measuring Adaptation, Colostomy, Education, Ileostomy, Self-Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Edanur Özkaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm 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 of the company representative that sells stoma materials routinely in the hospital.

Outcomes

Primary Outcome Measures

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
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.
The change in the adaptation of the experimental group according to the Ostomy Adjustment Inventory-23 scores at the end of the second 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.

Secondary Outcome Measures

The change in the ability of individuals with stoma to care for their stoma at the end of the 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.

Full Information

First Posted
September 5, 2022
Last Updated
September 5, 2022
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT05531331
Brief Title
The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma
Official Title
The Effect of Education Via Video Conferencing at Home on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stoma Ileostomy, Stoma Colostomy, Self Efficacy, Adjustment, Colorectal Cancer, Colorectal Disorders
Keywords
Adaptation, Colostomy, Education, Ileostomy, Self-Efficacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a parallel group randomized controlled study.
Masking
None (Open Label)
Masking Description
Masking was not performed in this study.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Individuals with stoma in the control group received the training of the company representative that sells stoma materials routinely in the hospital.
Intervention Type
Behavioral
Intervention Name(s)
At home education via video conferencing
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, 2nd month
Title
The change in the adaptation of the experimental group according to the Ostomy Adjustment Inventory-23 scores at the end of the second month
Description
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.
Time Frame
Baseline, 2nd month
Secondary Outcome Measure Information:
Title
The change in the ability of individuals with stoma to care for their stoma at the end of the 2nd month
Description
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.
Time Frame
Baseline, 2nd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz HARPUTLU, PhD, RN
Organizational Affiliation
Ankara University
Official's Role
Study Director
Facility Information:
Facility Name
Edanur Özkaya
City
Pamukkale
State/Province
Denizli
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD will share.
IPD Sharing Time Frame
starting 1 months after publication
IPD Sharing Access Criteria
all people access
Citations:
PubMed Identifier
33448938
Citation
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.
Results Reference
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PubMed Identifier
32700799
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
30793862
Citation
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.
Results Reference
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PubMed Identifier
30793857
Citation
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.
Results Reference
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PubMed Identifier
29775491
Citation
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.
Results Reference
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PubMed Identifier
30549366
Citation
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.
Results Reference
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PubMed Identifier
30562169
Citation
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.
Results Reference
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PubMed Identifier
33003121
Citation
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.
Results Reference
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PubMed Identifier
23051876
Citation
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.
Results Reference
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The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma

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