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?

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

102

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

October 16, 2023

Completed

12 months until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed

5 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed

Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

October 16, 2023

Last Update Submit

February 24, 2025

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapseperioperative carefollow up protocolnursing care

Outcome Measures

Primary Outcomes (2)

Quality of Life Scale
Evaluation of the quality of life of women who had pelvic organ prolapse surgery before and after the study. The scale was developed to evaluate the general health perceptions of patients with pelvic organ prolapse, the symptoms experienced during prolapse, and the effects and consequences of symptoms on quality of life. The scale consists of eight areas. There is no total score for the areas used in the scale, each area is scored individually.In calculating the score of the areas; a four-point scoring system is used for the expressions; does not affect at all, slightly affects, moderately affects and greatly affects; 1, 2, 3, 4, respectively. Each area of the scale is calculated separately depending on the questions it contains. The scale is scored between 0 and 100. High scores obtained from the scale indicate that the quality of life is impaired, while low scores indicate that the quality of life is better.
Baseline and at 2, 6, 10 and 14 weeks postoperatively
Functional Health Patterns
Evaluation of the health patterns of women who had pelvic organ prolapse surgery before and after study. It was developed by researchers in line with the relevant literature according to Gordon's Functional Health Patterns. The form, which is created separately for the preoperative, postoperative and post-discharge periods, covers 11 areas such as health perception, nutrition, excretion, activity, sleep, cognitive-perception style. The preoperative, postoperative and post-discharge health status of the patients, the problems they experience and the complications that may develop are determined. The items in the form are evaluated with yes-no and 0-10 (0 not affected at all, 10 affected a lot) Visual Analog Scale (VAS) and 5-point Likert (very good - good - medium - bad - very bad). There is no total score from the form. Each question is evaluated on its own.
Baseline and at 24.-48hours and 2, 6, 10 and 14 weeks postoperatively.

Secondary Outcomes (5)

Pelvic Organ Symptom Score
Baseline and at 2, 6, 10 and 14 weeks postoperatively.
Sexual Function
Baseline and after 14 weeks
Anxiety
Baseline and at 2, 6, 10 and 14 weeks postoperatively.
Nursing Diagnosis Checklist
At 2, 6, 10 and 14 weeks postoperatively.
Satisfaction Evaluation Form
At 14 weeks postoperatively.

Study Arms (6)

Preoperative Period, Education video

EXPERIMENTAL

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