Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-01 @ 5:42 PM
Study NCT ID:
NCT06826404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-fidelity Simulators and Standardized Patients on the Stoma Care
Sponsor:
Aydin Adnan Menderes University
Organization:
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: