NCT05531331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 5, 2022

Last Update Submit

September 5, 2022

Conditions

Keywords

Adaptation, Colostomy, Education, Ileostomy, Self-Efficacy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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 Outcomes (1)

  • The change in the ability of individuals with stoma to care for their stoma at the end of the 2nd month

    Baseline, 2nd month

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: At home education via video conferencing

Control Group

NO INTERVENTION

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

Interventions

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 Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous stoma opening experience,
  • Not being discharged within 10 days after the operation,
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edanur Özkaya

Pamukkale, Denizli, 06230, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Deniz HARPUTLU, PhD, RN

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking was not performed in this study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a parallel group randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student of master's degree

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 7, 2022

Study Start

November 1, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

All collected IPD will share.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
starting 1 months after publication
Access Criteria
all people access

Locations