Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583577
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
3D Ostomy Simulation for Patient Education
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for urologic bowel diversion patient education Using a randomized two group design we aim to determine whether the use of this model enhances patient knowledge self-care skills and confidence in ostomy care We will also evaluate changes in quality of life QOL and patient satisfaction comparing patients exposed to the 3D model to those receiving standard of care
The secondary aim of the study is to examine the differences between groups on patient outcomes including hospital duration mortality emergencyurgent health care visits readmissions and infections
Participants will be educated using 3D model simulation as part of their preoperative education experimental group or have standard education without using the simulation model comparator group Both groups will complete quality of life QOL ostomy adjustment and satisfaction with education surveys during their preoperative education visit and again during their routine follow-up visits a within 3 weeks after surgery b between 5- 8 weeks after surgery and c at approximately 3 months after surgery
The secondary aim of the study is to examine the differences between groups on patient outcomes including hospital duration mortality emergencyurgent health care visits readmissions and infections
Participants will be educated using 3D model simulation as part of their preoperative education experimental group or have standard education without using the simulation model comparator group Both groups will complete quality of life QOL ostomy adjustment and satisfaction with education surveys during their preoperative education visit and again during their routine follow-up visits a within 3 weeks after surgery b between 5- 8 weeks after surgery and c at approximately 3 months after surgery
Detailed Description:
Inclusion Criteria
Age18 and planning to undergo bowel diversion urologic surgery
Exclusion Criteria Current or prior ostomy formation cognitive function causing inability to care for stoma current pregnancy
Radom allocation and concealment During a regularly schedule preoperative clinic visit participants that consent to the study will be asked to complete a short 36 item quality-of-life questionnaire SF-36 The participant then be placed in either the experimental or comparator group using a random method similar to flipping a coin Random allocation sequencing will be predetermined by a database specialist who has no other role in the study Therefore all study staff clinic staff and investigators will be blinded to the allocation sequencing and will not be able to influence the group participants are assigned to
Preoperative education The clinic staff will provide participants with preoperative education according to their group assignment Participants in the experimental group will receive standard ostomy education supplemented by use of the simulation model Those allocated to the comparator group will receive standard preoperative education
Surveys During the preoperative visit prior to receiving education all participants will be asked to complete a quality of life survey the SF-36 After the education participants will be asked to complete the Ostomy Adjustment scale OAS and a visual analog scale VAS indicating their satisfaction with the ostomy education
During regular postoperative visits within 3 weeks between 5-8 weeks and approximately 3 months after leaving the hospital participants will be asked to complete the SF-36 the OAS and VAS All study procedures will be conducted at the surgeons clinic
Age18 and planning to undergo bowel diversion urologic surgery
Exclusion Criteria Current or prior ostomy formation cognitive function causing inability to care for stoma current pregnancy
Radom allocation and concealment During a regularly schedule preoperative clinic visit participants that consent to the study will be asked to complete a short 36 item quality-of-life questionnaire SF-36 The participant then be placed in either the experimental or comparator group using a random method similar to flipping a coin Random allocation sequencing will be predetermined by a database specialist who has no other role in the study Therefore all study staff clinic staff and investigators will be blinded to the allocation sequencing and will not be able to influence the group participants are assigned to
Preoperative education The clinic staff will provide participants with preoperative education according to their group assignment Participants in the experimental group will receive standard ostomy education supplemented by use of the simulation model Those allocated to the comparator group will receive standard preoperative education
Surveys During the preoperative visit prior to receiving education all participants will be asked to complete a quality of life survey the SF-36 After the education participants will be asked to complete the Ostomy Adjustment scale OAS and a visual analog scale VAS indicating their satisfaction with the ostomy education
During regular postoperative visits within 3 weeks between 5-8 weeks and approximately 3 months after leaving the hospital participants will be asked to complete the SF-36 the OAS and VAS All study procedures will be conducted at the surgeons clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None