Evaluation of the Effect of Two Different Methods on Stoma Compliance and Self-efficacy

NCT05308693 | Completed

• 1 other identifier: ATADEK 2021-13/04
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with stoma, apart from traditional methods, different methods whşch can be used in visual, auditory and motor skills are recommended as a part of education methods regarding stoma care. The aim of this study is to evaluate the effects of two different methods in teaching stoma care skills considering patients with colostomy/ileostomy on stoma compliance and self-efficacy levels. This research is the thesis study designed within the scope of the Surgical Diseases Nursing Master's program.

Conditions

Patient Relations, Nurse; Patient Satisfaction

Keywords

Stoma Adaptation; Self efficacy; Stoma Care education

Outcome Measures

Primary Outcomes (1)

• State Anxiety Level

  State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/ she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level

  after surgery, post-operative 1. day (first stoma care)

Secondary Outcomes (1)

• Stoma Self-Efficacy Scale

  The scale is filled in 3 times; 3 days after the surgery (post-operative 3. day) in hospital (1), and at the 3rd week after surgery (post-operative 21. day) at home by telephone (2) and 9th week after surgery (post-operative 63. day) (3) at home by phone

Other Outcomes (1)

• Adjustment Scale for Individuals with Ostomy

  The scale is filled in 3 times; 3 days after the surgery (post-operative 3. day) in hospital (1), and at the 3rd week after surgery (post-operative 21. day) at home by telephone (2) and 9th week after surgery (post-operative 63. day) (3) at home by phone

Study Arms (2)

Control-Classical patient education

NO INTERVENTION

Before the operation, the stoma area is marked, the patient is educated with the classical method brochure

Experimental-Patient Compatible Stoma Educational Material

EXPERIMENTAL

The stoma area is marked before the operation; A brochure is given to the patient. Practical training is given on the patient's own body with patient-compatible stoma training material.

Other: Education material - Patient Compatible Stoma Educational Material

Interventions

Education material - Patient Compatible Stoma Educational Material OTHER

It is an educational material made of rubber, similar to a stoma, that can be placed on the patient.

Experimental-Patient Compatible Stoma Educational Material

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-85 years
• Patients who have a colostomy or ileostomy for any reason (cancer, ulcerative colitis, chron, hernia, etc.)
• Patients who can speak and understand Turkish and do not have a psychological or neurological disease (Advanced Parkinson's, Alzheimer's, Depression, etc.)

You may not qualify if:

• Patients with visual and hearing impairment
• Patients that are unable to use their hands and upper extremities (hemiplegic, paraplegic, etc.)
• Patients who requires a revision surgery after surgery
• Patients whose temporary stoma was closed while in the data collection process
• Patients with postoperative complications and prolonged discharge period (evisceration, bleeding, perforation, etc.) will be excluded from the sample.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Yasemin Uslu

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

Location

Related Publications (6)

• 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: 32301580 BACKGROUND

• Stelton S. CE: Stoma and Peristomal Skin Care: A Clinical Review. Am J Nurs. 2019 Jun;119(6):38-45. doi: 10.1097/01.NAJ.0000559781.86311.64.

  PMID: 31135430 RESULT

• Giordano V, Nicolotti M, Corvese F, Vellone E, Alvaro R, Villa G. Describing self-care and its associated variables in ostomy patients. J Adv Nurs. 2020 Nov;76(11):2982-2992. doi: 10.1111/jan.14499. Epub 2020 Aug 26.

  PMID: 32844474 RESULT

• 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: 30793857 RESULT

• Zhang Y, Xian H, Yang Y, Zhang X, Wang X. Relationship between psychosocial adaptation and health-related quality of life of patients with stoma: A descriptive, cross-sectional study. J Clin Nurs. 2019 Aug;28(15-16):2880-2888. doi: 10.1111/jocn.14876. Epub 2019 May 5.

  PMID: 30939212 RESULT

• Cheng F, Meng AF, Yang LF, Zhang YN. The correlation between ostomy knowledge and self-care ability with psychosocial adjustment in Chinese patients with a permanent colostomy: a descriptive study . Ostomy Wound Manage. 2013 Jul;59(7):35-8.

  PMID: 23846005 RESULT

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Yasemin Uslu, Asisst.Prof

  Acıbadem Mehmet Ali Aydınlar Üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisst. Prof.

Model Details: Randomized controlled

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 4, 2022
• Study Start: August 1, 2021
• Primary Completion: June 19, 2023
• Study Completion: June 19, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)