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

Overview

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.

Interventions

• Other Preoperative Period, Postoperative Period, 2th week after discharge, 6th week after discharge, 10th week after discharge, 14th week after discharge
  Showing training videos to patients before and after pelvic organ prolapse surgery and following up after discharge

Primary outcome measures

• Quality of Life Scale [Time frame: Baseline and at 2, 6, 10 and 14 weeks postoperatively]
• Functional Health Patterns [Time frame: Baseline and at 24.-48hours and 2, 6, 10 and 14 weeks postoperatively.]

Secondary outcome measures (5)

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Gulhane Training and Research Hospital — Ankara

Publications

• Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. doi: 10.1067/mob.2002.123819. PMID 12066091
• Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581. PMID 31851453
• 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. PMID 12955337
• Hagen S, Glazener C, Sinclair L, Stark D, Bugge C. Psychometric properties of the pelvic organ prolapse symptom score. BJOG. 2009 Jan;116(1):25-31. doi: 10.1111/j.1471-0528.2008.01903.x. Epub 2008 Oct 8. PMID 18947342
• Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):176-81; discussion 181. doi: 10.1007/s00192-004-1225-x. Epub 2004 Oct 21. PMID 15875234
• 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. PMID 36741293
• 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. PMID 34554145
• 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. PMID 19374034

Identifiers

NCT: NCT06631508 · nozbek

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗