High-fidelity Simulators and Standardized Patients on the Stoma Care

Not Applicable

Active, not recruiting

• Conditions: Simulation-based Learning; Nursing Students; Ostomy

• Registration Number: NCT06826404
• Lead Sponsor: Aydin Adnan Menderes University

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.

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 Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-14
• Study Start: 2025-03-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-06-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stoma care skill points	Within 3 weeks after stoma care skill teaching	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.
Simulation experience satisfaction level	Within 3 weeks after stoma care skill teaching	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.

Secondary Outcome Measures

Name	Time	Method
Recommendation score	Within 3 weeks after stoma care skill teaching	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.

Trial Locations

Locations (1)

Aydın Adnan Menderes University; 🇹🇷 Aydın, Efeler, Turkey