Clinical trial NCT06631508: Perioperative Follow-up Protocols for Pelvic Organ Prolapse Surgery
Official title: Development of Perioperative Follow-up Protocols and Evaluation of Their Effectiveness for Women Aged 30-65 Having Pelvic Organ Prolapse Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
perioperative care
follow up protocol
nursing care
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 102
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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?

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life Scale
timeFrame: Baseline and at 2, 6, 10 and 14 weeks postoperatively
measure: Functional Health Patterns
timeFrame: Baseline and at 24.-48hours and 2, 6, 10 and 14 weeks postoperatively.
Secondary outcomes:
measure: Pelvic Organ Symptom Score
timeFrame: Baseline and at 2, 6, 10 and 14 weeks postoperatively.
measure: Sexual Function
timeFrame: Baseline and after 14 weeks
measure: Anxiety
timeFrame: Baseline and at 2, 6, 10 and 14 weeks postoperatively.
measure: Nursing Diagnosis Checklist
timeFrame: At 2, 6, 10 and 14 weeks postoperatively.
measure: Satisfaction Evaluation Form
timeFrame: At 14 weeks postoperatively.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
Study officials:
affiliation: SBU Health Science Faculty Gulhane Nursing Faculty
name: Gulsah Kök
role: STUDY_DIRECTOR
References:
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citation: Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. doi: 10.1007/s00192-003-1063-2. Epub 2003 Jul 25.
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citation: Zhang T, Qi X. Enhanced Nursing Care for Improving the Self-Efficacy & Health-Related Quality of Life in Patients with a Urostomy. J Multidiscip Healthc. 2023 Jan 29;16:297-308. doi: 10.2147/JMDH.S394515. eCollection 2023.
citation: Rockefeller NF, Jeppson P, Komesu YM, Meriwether KV, Ninivaggio C, Dunivan G. Preferences for Preoperative Education: A Qualitative Study of the Patient Perspective. Female Pelvic Med Reconstr Surg. 2021 Oct 1;27(10):633-636. doi: 10.1097/SPV.0000000000001014.
citation: Richardson K, Hagen S. The role of nurses in the management of women with pelvic organ prolapse. Br J Nurs. 2009 Mar 12-25;18(5):294-6, 298-300. doi: 10.12968/bjon.2009.18.5.40710.
citation: Haya N, Feiner B, Baessler K, Christmann-Schmid C, Maher C. Perioperative interventions in pelvic organ prolapse surgery. Cochrane Database Syst Rev. 2018 Aug 19;8(8):CD013105. doi: 10.1002/14651858.CD013105.
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