High-fidelity Simulators and Standardized Patients on the Stoma Care

The Effects of Using High-fidelity Simulators and Standardized Patients on the Stoma Care Skills and Learning Satisfaction Level on Nursing Students: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ostomy; Nursing Students; Simulation-based Learning
• Intervention / Treatment: Device: Training provided with a wearable ostomy model and standardized patient; Other: Training low fidelity simulator

Detailed Description

Phase 1: Design of wearable colostomy model The wearable colostomy model to be designed within the scope of the project will be soft, skin-sensitive, in accordance with the real anatomy and will have wearable qualities with the help of hanger-velcro tape. There will be one healthy and normal-looking stoma on the model. The velcro tape system of the model will be made of elastic and adjustable velcro tapes according to waist measurements and will be placed on the back of the belt. The width of the tape system will be 5 cm and the length will be 90 cm. The hooked part of the velcro tapes will be fixed to one end of the elastic belt and the looped part will be fixed to the other end, the looped part will be kept longer and the belt will be adjustable at different lengths. The velcro tapes will be placed on the fabric and will be joined by sewing. On this system, a soft skin-colored medical silicone human skin will be made by sewing or gluing the abdominal surface. A dark pink stoma appearance will be created on this abdominal surface, with a diameter of 2.5 cm, slightly raised and natural from the skin surface. Modeling clay will be used to create this appearance.

Phase 2: Wearable colostomy model stoma care training What is a stoma, nursing care after stoma surgery, peristomal area care 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 with plain narration and discussion methods, not exceeding 30 slides. Both groups will receive this training at the same time. After this explanation, the skill guide "Changing the Ostomy Bag and Nursing Care of the Peristomal Area" developed by the facilitator of the study based on literature will be developed. This guide will be sent to 5 academicians who are experts in the field of Surgical Disease Nursing, expert opinions will be received and the skill learning guide will be finalized in line with the opinions received. According to the skill steps in this learning guide, the researcher will perform stoma care on a wearable colostomy model by a volunteer student who is doing her doctorate in Surgical Diseases Nursing and will provide nursing students with the opportunity to ask questions, then she will be provided with the opportunity to demonstrate the skill on the wearable stoma model twice by following the steps in the learning guide. The same process will be performed with the other group on an inanimate mannequin and with the same steps. In the study, one group will perform the skill with a wearable ostomy model, while the other group will teach the skill on an inanimate mannequin with an ostomy. Skill teaching will be planned on different days and times, and the level of interaction between the groups regarding the skill teaching will be minimized.

Phase 3: Evaluation of nursing students' stoma care skills, satisfaction with the simulation experience and their recommendations All students will perform the skill on a standard patient with a wearable ostomy model. This process will be conducted by an independent researcher. This scoring and evaluation will take place in a laboratory environment. After scoring, the simulation experience satisfaction scale will be given to the students and they will be asked to fill it out.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Efeler
    • Aydın, Efeler, Turkey, 09010
      • Aydın Adnan Menderes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (Standardized patient with weareble ostomy model); 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; 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.
Active Comparator: Control group (Low fidelity simulator); The study group will be taught stoma care skills with a low fidelity simulator.	Other: Training low fidelity simulator; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommendation score	The ostomy model developed for this study was created for recommendation scores regarding its use in simulation training. A scoring system will be used to evaluate students' stoma care skill teaching with a wearable ostomy model from 0 to 10. As the student's score increases, it will be interpreted that the model's usability in teaching stoma care skills is high.	Within 3 weeks after stoma care skill teaching

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Ezgi Arslan, PhD, Director; Study Chair: Havva Yönem Amaç, PhD, Researcher; Study Chair: Sultan Özkan, PhD, Researcher

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Nursing students; Simulation; Ostomy care
• Other Study ID Numbers: Wearable Ostomy Model

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No