Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631508
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2023-10-16
Brief Title:
Perioperative Follow-up Protocols for Pelvic Organ Prolapse Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of Perioperative Follow-up Protocols and Evaluation of Their Effectiveness for Women Aged 30-65 Having Pelvic Organ Prolapse Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
POPFollowup
Brief Summary:
The goal of this clinical trial is to develop perioperative follow-up and evaluation of their effectiveness protocols in women aged 30-65 having pelvic organ prolapse surgery
The main questions it aims to answer are
Is the perioperative follow up protocol developed for women aged 30-65 having pelvic organ prolapse surgery effective
Does the developed perioperative follow up protocol for women aged 30-65 having pelvic organ prolapse surgery have an effect on quality of life pelvic organ symptom score sexual function functional health patterns and anxiety
The main questions it aims to answer are
Is the perioperative follow up protocol developed for women aged 30-65 having pelvic organ prolapse surgery effective
Does the developed perioperative follow up protocol for women aged 30-65 having pelvic organ prolapse surgery have an effect on quality of life pelvic organ symptom score sexual function functional health patterns and anxiety
Detailed Description:
In order to maintain holistic care maintaining communication with the individual after discharge and providing individual counseling regarding the problems experienced have an important place in patient follow-up In this context perioperative consultancy should be provided under nurse management to make it easier for patients to cope with physical and psychosocial problems improve quality of life and ensure continuity of care Therefore in this research the aim is to develop perioperative follow up protocols and evaluate their effectiveness for women aged 30-65 who have pelvic organ prolapse surgery
The sample of the research It is planned to consist of a total of 102 women 51 in the Follow-up Group and 51 in the Control Group who meet the inclusion criteria and voluntarily agreed to participate in the research Calculated using GPower 317 program After informed consent is obtained full randomization technique will be used to assign participants to follow-up and control groups Full randomization will be done via the website httpwwwrandomizerorg Two computer-generated randomization sequences will be applied on a one-to-one basis
During the pre-test and post-test data collection phase it is planned to use the Descriptive Characteristics Form Pelvic Organ Prolapse Quality of Life Scale Pelvic Organ Symptom Score Pelvic Organ ProlapseUrinary Incontinence Sexual Function Questionnaire Form State-Trait Anxiety Inventory Short Version and Functional Health Patterns Assessment Form in the perioperative period
After preoperative data is collected the Follow-up Group will be shown a preoperative patient education video In the postoperative period Follow-up Groups data will be collected within 24-48 hours and the patient will be shown a postoperative education video before discharge After discharge at the 2nd 6th 10th and 14th weeks Follow-up Groups will be followed up by phone and their data will be collected In addition a satisfaction form to evaluate the education videos will be applied to the Follow-up Group in the 14th week The Control Group will not receive any intervention by the researcher and will receive routine perioperative care Control Groups data will be collected in the preoperative and postoperative period Additionally Control Groups data will be collected by phone at the 2nd 6th 10th and 14th weeks after discharge and a postoperative education video will be watched after the data is collected at the 14th week
The sample of the research It is planned to consist of a total of 102 women 51 in the Follow-up Group and 51 in the Control Group who meet the inclusion criteria and voluntarily agreed to participate in the research Calculated using GPower 317 program After informed consent is obtained full randomization technique will be used to assign participants to follow-up and control groups Full randomization will be done via the website httpwwwrandomizerorg Two computer-generated randomization sequences will be applied on a one-to-one basis
During the pre-test and post-test data collection phase it is planned to use the Descriptive Characteristics Form Pelvic Organ Prolapse Quality of Life Scale Pelvic Organ Symptom Score Pelvic Organ ProlapseUrinary Incontinence Sexual Function Questionnaire Form State-Trait Anxiety Inventory Short Version and Functional Health Patterns Assessment Form in the perioperative period
After preoperative data is collected the Follow-up Group will be shown a preoperative patient education video In the postoperative period Follow-up Groups data will be collected within 24-48 hours and the patient will be shown a postoperative education video before discharge After discharge at the 2nd 6th 10th and 14th weeks Follow-up Groups will be followed up by phone and their data will be collected In addition a satisfaction form to evaluate the education videos will be applied to the Follow-up Group in the 14th week The Control Group will not receive any intervention by the researcher and will receive routine perioperative care Control Groups data will be collected in the preoperative and postoperative period Additionally Control Groups data will be collected by phone at the 2nd 6th 10th and 14th weeks after discharge and a postoperative education video will be watched after the data is collected at the 14th week
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