Perioperative Follow-up Protocols for Pelvic Organ Prolapse Surgery (POPFollowup)

Saglik Bilimleri Universitesi

Status: Not yet enrolling

Conditions: Pelvic Organ Prolapse

Treatments: Other: Preoperative Period, Postoperative Period, 2th week after discharge, 6th week after discharge, 10th week after discharge, 14th week after discharge

Study type: Interventional

Funder types: Other

Identifiers

NCT06631508

nozbek

Details and patient eligibility

About

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?

Full 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 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.

Enrollment: 102 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being stage ≥2 according to POP Classification (POP-Q),
• Being between 30-65 years old,
• Being sexually active,
• Ability to read and write,
• Ability to speak Turkish,
• Ability to use phone
• Having a phone that can be reached at all times and
• Agreeing to participate in the study

Exclusion criteria

• 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,
• Not being able to speak Turkish,
• Inability to use the phone
• Not having a phone that can be reached at all times and
• Not agreeing to participate in the study
• Discontinue the research for any reason

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 6 patient groups

Preoperative Period, Education video

Experimental group

Description:

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

Treatment:

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

Postoperative Period, Education video

Experimental group

Description:

Patient data will be collected within 24-48 hours in the postoperative period. The postoperative patient education video will be watched before the patient is discharged. If patient has any questions, they will be answered. Control Group: No intervention. Control Group's data will be collected. Data collection forms to be used in the postoperative period: * Postoperative Data Collection Form * State-Trait Anxiety Inventory Short Version * Postoperative Functional Health Patterns Evaluation Form * Nursing Diagnoses Checklist After POP Surgery

Treatment:

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

2th week after discharge

Experimental group

Description:

The patient's data will be collected by telephone follow-up two weeks after discharge. Control Group: No intervention. Control Group's data will be collected. Data collection forms to be used at the two weeks after discharge: * Pelvic Organ Prolapse Quality of Life Scale * Pelvic Organ Prolapse Symptom Score * State-Trait Anxiety Inventory Short Version * After Discharge Functional Health Patterns Evaluation Form * Nursing Diagnoses Checklist After POP Surgery

Treatment:

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

6th week after discharge

Experimental group

Description:

The patient's data will be collected by telephone follow-up six weeks after discharge. Control Group: No intervention. Control Group's data will be collected. Data collection forms to be used at the six weeks after discharge: * Pelvic Organ Prolapse Quality of Life Scale * Pelvic Organ Prolapse Symptom Score * State-Trait Anxiety Inventory Short Version * After Discharge Functional Health Patterns Evaluation Form * Nursing Diagnoses Checklist After POP Surgery

Treatment:

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

10th week after discharge

Experimental group

Description:

The patient's data will be collected by telephone follow-up ten weeks after discharge. Control Group: No intervention. Control Group's data will be collected. Data collection forms to be used at the ten weeks after discharge: * Pelvic Organ Prolapse Quality of Life Scale * Pelvic Organ Prolapse Symptom Score * State-Trait Anxiety Inventory Short Version * After Discharge Functional Health Patterns Evaluation Form * Nursing Diagnoses Checklist After POP Surgery

Treatment:

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

14th week after discharge

Experimental group

Description:

The patient's data will be collected by telephone follow-up fourteen weeks after discharge. Additionally, on the 14th week, a satisfaction form will be applied to the Follow-up Group to evaluate the education videos. Control Group: No intervention. Control Group's data will be collected. After the data is collected, postoperative education video will be watched. Data collection forms to be used at the fourteen weeks after discharge: * 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 * After Discharge Functional Health Patterns Evaluation Form * Nursing Diagnoses Checklist After POP Surgery * Satisfaction Evaluation Form (Only Follow-up Group)

Treatment:

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