Perioperative Follow-up Protocols for Pelvic Organ Prolapse Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-12-31

Brief Summary

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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?

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Detailed Description

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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 G.Power 3.1.7 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 http://www.randomizer.org/. 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 Prolapse/Urinary 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 Group's 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 Group's 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 Group's data will be collected in the preoperative and postoperative period. Additionally, Control Group's 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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled intervention trial After informed voluntary 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 http://www.randomizer.org/. Two computer-generated randomization sequences will be applied on a one-to-one basis.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Preoperative Period, Education video

Follow-up Group: Preoperative data of patients who will undergo pelvic organ prolapse surgery will be collected. Then, the preoperative patient education video will be watched. If patient has any questions will be answered.

Control Group: No intervention. Control Group's data will be collected.

Data collection forms to be used in the preoperative period:

* Introductory Characteristics Form
* Pelvic Organ Prolapse Quality of Life Scale
* Pelvic Organ Prolapse Symptom Score
* Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
* State-Trait Anxiety Inventory Short Version
* Preoperative Functional Health Patterns Evaluation Form

Group Type EXPERIMENTAL