Perioperative Follow-up Protocols for Pelvic Organ Prolapse Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorSaglik Bilimleri Universitesi

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Being stage ≥2 according to POP Classification (POP-Q),

Being between 30-65 years old,

Being sexually active,

Ability to read and write,

Disqualifiers

Being stage <2 according to POP Classification (POP-Q),

Being between <30 and >65 years of age,

Not being sexually active,

Not being able to read and write,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative Period, Postoperative Period, 2th week after discharge, 6th week after discharge, 10th week after discharge, 14th week after discharge

    Other intervention

    Showing training videos to patients before and after pelvic organ prolapse surgery and following up after discharge

Treatment groups

102 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Preoperative Period, Education videoExperimental treatment 1 intervention
Group B: Postoperative Period, Education videoExperimental treatment 1 intervention
Group C: 2th week after dischargeExperimental treatment 1 intervention
Group D: 6th week after dischargeExperimental treatment 1 intervention
Group E: 10th week after dischargeExperimental treatment 1 intervention
Group F: 14th week after dischargeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and at 2, 6, 10 and 14 weeks postoperatively
2

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.

Time frame
Baseline and at 24.-48hours and 2, 6, 10 and 14 weeks postoperatively.

Secondary outcomes

1

Pelvic Organ Symptom Score

Evaluation of the pelvic organ symptom score of women who had pelvic organ prolapse surgery before and after study. The scale is used to evaluate symptoms of pelvic organ prolapse. There are seven questions in the scale, each with five answers. The answers are formed as never (0 points), a little (1 point), sometimes (2 points), often (3 points) and always (4 points). An increase in the score obtained from the scale indicates an increase in symptoms. In addition, women indicate which of the seven symptoms bother them the most.

Time frame
Baseline and at 2, 6, 10 and 14 weeks postoperatively.
2

Sexual Function

Evaluation of sexual function of women who had pelvic organ prolapse surgery before and after study. Questionnaire developed to evaluate sexual function specific to the urogynecological field consists of 12 items. Questions 1-4 on the form are scored as 4 points = always and 0 = never, while questions 5-12 are scored as 0 = always and 4 points = never. A minimum of 0 and a maximum of 48 points can be obtained from the questionnaire. As the score of the questionnaire increases, it indicates an improvement in sexual function. The questionnaire is divided into three sub-dimensions: behavioral/emotional status (questions 1-4), physical status (questions 5-9) and partner-related status (questions 10-12).

Time frame
Baseline and after 14 weeks
3

Anxiety

Evaluation of the anxiety of women who had pelvic organ prolapse surgery before and after study. Two scales measuring state and trait anxiety are used. The scales consist of 5 items and are of 4-point Likert type. Individuals who score 10 and above on State Anxiety Inventory Scale-5 and 14 and above on Trait Anxiety Inventory Scale-5 are considered to be clinically anxious.

Time frame
Baseline and at 2, 6, 10 and 14 weeks postoperatively.
4

Nursing Diagnosis Checklist

This form prepared by researchers lists nursing diagnoses to identify problems that may develop in patients at 24-48 hours postoperatively and at 2, 6, 10 and 14 weeks after discharge. These diagnoses are systematized in 11 areas according to Gordon's Functional Health Patterns Model. There is no score calculation in this form, and the most frequently used diagnoses will be calculated as percentages.

Time frame
At 2, 6, 10 and 14 weeks postoperatively.

Other outcomes

Sponsors and contacts

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