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

NCT ID: NCT05531331

Last Updated: 2022-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stoma Ileostomy Stoma Colostomy Self Efficacy Adjustment Colorectal Cancer Colorectal Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a parallel group randomized controlled study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Masking was not performed in this study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

At home education via video conferencing

Intervention Type BEHAVIORAL

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.

Control Group

Individuals with stoma in the control group received the training of the company representative that sells stoma materials routinely in the hospital.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

At home education via video conferencing

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Edanur Ozkaya

Student of master's degree

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deniz HARPUTLU, PhD, RN

Role: STUDY_DIRECTOR

Ankara University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Edanur Özkaya

Pamukkale, Denizli, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 33448938 (View on PubMed)

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.

Reference Type RESULT
PMID: 32700799 (View on PubMed)

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.

Reference Type RESULT
PMID: 35930059 (View on PubMed)

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.

Reference Type RESULT
PMID: 30793862 (View on PubMed)

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.

Reference Type RESULT
PMID: 30793857 (View on PubMed)

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.

Reference Type RESULT
PMID: 29775491 (View on PubMed)

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.

Reference Type RESULT
PMID: 30549366 (View on PubMed)

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.

Reference Type RESULT
PMID: 30562169 (View on PubMed)

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.

Reference Type RESULT
PMID: 33003121 (View on PubMed)

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.

Reference Type RESULT
PMID: 23051876 (View on PubMed)

Ozkaya E, Harputlu D. The Effect of Education Via Videoconferencing at Home on Individuals' Self-efficacy and Adaptation to Life with a Stoma: A Randomized Controlled Study. Adv Skin Wound Care. 2024 Feb 1;37(2):86-94. doi: 10.1097/ASW.0000000000000098.

Reference Type DERIVED
PMID: 38241451 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

56786525-050.04.04/236864

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Flipped Learning Model on the Stoma Care
NCT06397534 NOT_YET_RECRUITING NA