NCT05664503

Brief Summary

To explore the effect of the Stoma Mobile application-based training method on the psychosocial adjustment, self-efficacy, and development of peristomal skin complications in individuals with a stoma. Quasi-experimental study with a post-test control group. Patients who met the inclusion criteria were randomly selected. While the experimental group (n=30) received training with the Stoma Mobile application, the control group (n=30) received training with the booklet. Stoma compliance, self-efficacy level, and the presence of complications were compared in both groups in the first and third months after discharge. H11: Individuals who receive stoma care training via STOMA-M will have a higher adaptation to stomas than individuals who receive stoma care training via a booklet. H12: The SE levels of individuals who receive stoma care training via STOMA-M will be higher than those who receive stoma care training via a booklet. H13: Peristomal skin complications of individuals who receive stoma care training via STOMA-M will be lower than those who receive stoma care training via a booklet. The population of the study included patients who had a stoma for the first time, were in a university hospital in Istanbul between December 2020 and December 2021, and who were 18 years of age and older, literate, without any physical and psychological disabilities, able to use smartphones, and willing to participate in the study. Patients who were in the same room or underwent a urostomy were not included in the study. The experimental group using the Stoma Health Mobile application had higher psychosocial adjustment and self-efficacy scores than the control group, and the peristomal skin lesion complication rate was lower than that of the control group. Social self-efficacy positively affects stoma compliance, and the Stoma Mobile application positively affects the level of social self-efficacy and adaptation of ostomates to the stoma

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 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

22 days

First QC Date

December 7, 2022

Last Update Submit

December 22, 2022

Conditions

Keywords

ostomy adjustmentmobile applicationself-efficacyperistomal skin lesionsnursing

Outcome Measures

Primary Outcomes (1)

  • Change in Adjustment Scale for Individuals with Ostomy

    It is a self-assessment scale consisting of 23 items developed by to determine the compliance of individuals with stoma. 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'

    Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)

Secondary Outcomes (1)

  • Stoma Self-Efficacy Scale

    Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)

Other Outcomes (1)

  • Evaluation Tool for Peristomal Skin Lesions; SACS

    Evaluation of the differences between scales score - The scale is filled in 2 times; After being discharged from the hospital the first months(1) and third months (2)

Study Arms (2)

Booklet

NO INTERVENTION

Control-Classical patient education before the operation, the patient is educated with the classical method brochure.

STOMA-M

EXPERIMENTAL

Patients are educated with the mobil aplikasyon method.

Other: Assigned Interventions STOMA-M

Interventions

The training, which includes information on stoma care, maintenance of daily life activities, and complication management, was given to the patients in the experimental group via the STOMA-M.

STOMA-M

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • Literate,
  • Without any physical and psychological disabilities,
  • Able to use smartphones
  • Willing to participate in the study.

You may not qualify if:

  • Patients who were in the same room or underwent a urostomy were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eylem Toğluk Yiğitoğlu

Istanbul, Turkey (Türkiye)

Location

Related Publications (12)

  • Yigitoglu ET, Sendir M. Effect of a mobile patient education application on adjustment to stoma and development of peristomal skin lesions: a quasi-experimental study. Wound Manag Prev. 2021 Dec;67(12):30-40.

    PMID: 35030542BACKGROUND
  • Yigitoglu, E. T., & Sendir, M. (2021a). Mobile Application in Stoma Care Education: Stoma-M. Journal of Education and Research in Nursing, 18 (2), 210-216. DOI: 10.5152/jern.2021.85688

    BACKGROUND
  • Karacay P, Togluk Yigitoglu E, Karadag A. The validity and reliability of the Stoma Self-Efficacy Scale: A methodological study. Int J Nurs Pract. 2020 Dec;26(6):e12840. doi: 10.1111/ijn.12840. Epub 2020 Apr 17.

    PMID: 32301580BACKGROUND
  • Karadağ, A., Göçmen, Z. B., Korkut, H., & Çelik, B. (2011). Turkish adaptation of the adjustment scale for individuals with ostomy. National Journal of Surgery, 27(4), 206-211.

    BACKGROUND
  • Ay A, Bulut H. Assessing the Validity and Reliability of the Peristomal Skin Lesion Assessment Instrument Adapted for Use in Turkey. Ostomy Wound Manage. 2015 Aug;61(8):26-34.

    PMID: 26291898BACKGROUND
  • Pate K, Powers K, Coffman MJ, Morton S. Improving Self-Efficacy of Patients With a New Ostomy With Written Education Materials: A Quality Improvement Project. J Perianesth Nurs. 2022 Oct;37(5):620-625. doi: 10.1016/j.jopan.2021.11.020. Epub 2022 Mar 5.

    PMID: 35260298BACKGROUND
  • 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.

    PMID: 29775491BACKGROUND
  • 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.

    PMID: 30793857BACKGROUND
  • Wound, Ostomy and Continence Nurses Society; Guideline Development Task Force. WOCN Society Clinical Guideline: Management of the Adult Patient With a Fecal or Urinary Ostomy-An Executive Summary. J Wound Ostomy Continence Nurs. 2018 Jan/Feb;45(1):50-58. doi: 10.1097/WON.0000000000000396.

    PMID: 29300288BACKGROUND
  • Yaşar, Z., & Üstündağ, H. (2021). Determination of quality of life and self-efficacy levels of patients with stoma. Journal of Celal Bayar University Health Sciences Institute, 8(1), 107-115.

    BACKGROUND
  • Collado-Boira EJ, Machancoses FH, Folch-Ayora A, Salas-Medina P, Bernat-Adell MD, Bernalte-Marti V, Temprado-Albalat MD. Self-Care and Health-Related Quality of Life in Patients with Drainage Enterostomy: A Multicenter, Cross Sectional Study. Int J Environ Res Public Health. 2021 Mar 2;18(5):2443. doi: 10.3390/ijerph18052443.

    PMID: 33801488BACKGROUND
  • Heidari-Beni F, Esmaeilian S, Yousefi F, Zarei MR, Farahani MA. Comparison of Face-to-Face Education and Multimedia Software Education on Adjustment of Patients With Intestinal Ostomy: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2022 Mar-Apr 01;49(2):152-157. doi: 10.1097/WON.0000000000000854.

    PMID: 35255067BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Quasi-experimental study with a post-test control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisst. Prof.

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 23, 2022

Study Start

November 18, 2020

Primary Completion

December 10, 2020

Study Completion

December 20, 2021

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations