High-fidelity Simulators and Standardized Patients on the Stoma Care

NCT06826404 | Active Not Recruiting DMC

• 1 other identifier: Wearable Ostomy Model
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled study to investigate the effects of skill training on a low-fidelity simulator with a standardized patient using a wearable ostomy model on the stoma care skills and satisfaction levels of nursing students.

Conditions

Simulation-based Learning; Nursing Students; Ostomy

Keywords

Nursing students; Simulation; Ostomy care

Outcome Measures

Primary Outcomes (2)

• Stoma care skill points

  The key developed by İncesu and his colleagues consists of 23 items. The items in the key include the gradual steps of stoma care such as explaining the procedure to the patient, preparing the materials, and protecting privacy regarding the students' stoma care skills. The key is planned as 'insufficient' (0 points) if the practitioner cannot perform the application by observing the student or does it wrong, 'partially sufficient' (1 point) if the step is applied correctly but in the wrong order, and 'sufficient' (2 points) if the step is applied correctly and in the wrong order. The minimum score to be obtained from the key is 0, and the maximum score is 46. Although there is no cut-off value for the scale, it is interpreted that the care skill increases as the score obtained increases. The scale will be applied once by an independent evaluator after the skill training for all students.

  Within 3 weeks after stoma care skill teaching

• Simulation experience satisfaction level

  The scale developed by Tüzer and his colleagues consists of three sub-dimensions: analysis and reflection, clinical reasons and clinical learning. The total number of items in the scale is 18. The responses to be given for each item are scored as strongly disagree, disagree, not sure, agree, strongly agree. Although there is no cut-off value for the scale, it is interpreted that as the score increases, the level of satisfaction increases. After the simulation evaluation process is completed, students will fill out the scale once based on their self-reports.

  Within 3 weeks after stoma care skill teaching

Secondary Outcomes (1)

• Recommendation score

  Within 3 weeks after stoma care skill teaching

Study Arms (2)

Intervention group (Standardized patient with weareble ostomy model)

EXPERIMENTAL

The study group will be taught stoma care skills with a standardized patient wearing a wearable ostomy model.

Device: Training provided with a wearable ostomy model and standardized patient

Control group (Low fidelity simulator)

ACTIVE COMPARATOR

The study group will be taught stoma care skills with a low fidelity simulator.

Other: Training low fidelity simulator

Interventions

Training provided with a wearable ostomy model and standardized patient DEVICE

The subjects of what is stoma, nursing care after stoma surgery, and care of the peristomal area will be explained to the students participating in the study theoretically by the responsible director in a session and for a maximum of 30 minutes with plain narration and discussion methods, not exceeding 30 slides. Both groups will receive this training at the same time. After this explanation, stoma care will be performed on a wearable colostomy model by a volunteer student who is doing her doctorate in Surgical Diseases Nursing in accordance with the skill guide "Changing the Ostomy Bag and Nursing Care of the Peristomal Area" developed by the director of the study based on literature, and nursing students will be given the opportunity to ask questions, and then the skill will be demonstrated twice on the wearable stoma model by following the steps in the learning guide.

Intervention group (Standardized patient with weareble ostomy model)

Training low fidelity simulator OTHER

The subjects of what is stoma, nursing care after stoma surgery, and care of the peristomal area will be explained to the students participating in the study theoretically by the responsible facilitator in one session and for a maximum of 30 minutes, using plain narration and discussion methods, not exceeding 30 slides. Both groups will receive this training at the same time. After this explanation, skill training will be carried out on a lifeless mannequin in accordance with the skill guide "Changing the Ostomy Bag and Nursing Care of the Peristomal Area" developed by the facilitator of the study based on literature.

Control group (Low fidelity simulator)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successfully completing the Internal Medicine Nursing course
• Taking the Surgical Disease Nursing course
• Not having any absences from the 7th week (the week when the
• Gastrointestinal System Surgery topic is covered)
• Participating in the study process completely

You may not qualify if:

• Retaking Surgical Nursing course due to failure
• Participating in a different skill course related to stoma care
• Having provided stoma care at any time before

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Efeler, 09010, Turkey (Türkiye)

Location

Study Officials

• Ezgi Arslan, PhD

  Director

  PRINCIPAL INVESTIGATOR

• Havva Yönem Amaç, PhD

  Researcher

  STUDY CHAIR

• Sultan Özkan, PhD

  Researcher

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Model Details: Nursing students who were to be taught stoma care skills with a standardized patient vs. low-fidelity simulator included in the study were randomly assigned to a study and a control group (1:1 randomization).

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 14, 2025
• Study Start: March 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)