NCT07065188

Brief Summary

The aim of this study to investigate the effect of preoperative pain hypervigilance on postoperative pain, bladder-bowel symptoms and sexual life after vaginal surgery and to compare these parameters before and after surgery. Pain vigilance (Pain Vigilance and Awareness Questionnaire-PVAQ), pain catastrophizing (Pain Catastrophizing Scale-PCS), bladder-bowel function (Australian Pelvic Floor Questionnaire-APFQ), and sexual function (Female Sexual Function Index (FSFI)) of women were recorded before and after surgery. Visual analogue scales were used to assess the postoperative pain intensity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

June 30, 2025

Last Update Submit

February 26, 2026

Conditions

Vaginal Surgery

Keywords

Vaginal surgerypain vigilancesexual function

Outcome Measures

Primary Outcomes (1)

  • Pain Vigilance and Awareness Questionnaire

    The Turkish version of the PVAQ will be used to measure alertness to pain and pain awareness. In the 16-item Likert-type questionnaire, "never" equals 0, "rarely" equals 1, "sometimes" equals 4 and "always" equals 5 points. Items 8 and 16 of the questionnaire are reverse scored. The lowest score is 0 and the highest score is 80. A higher score indicates more pain awareness.

    Before and first day of after surgery (first postoperative day)

Secondary Outcomes (4)

  • Pain Catastrophizing Scale

    Before and first day of after surgery (first postoperative day)

  • Australian Pelvic Floor Questionnaire

    Before and after eight weeks of vaginal surgery

  • Female Sexual Function Index

    Before and after eight weeks of vaginal surgery

  • Visual Analog Scale

    Before and first day after surgery

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Have undergone vaginal surgery

You may qualify if:

  • Being aged 18-40.
  • Being able to read and write Turkish.
  • Have undergone vaginal surgery.

You may not qualify if:

  • Presence of any confounding condition in post-operative pain severity (patients with a history of chronic pelvic pain and/or endometriosis or pelvic inflammatory disease),
  • Having conditions in which sexual activity is contraindicated and should be restricted (genital infection, etc.),
  • Vulvovaginal infection,
  • Having a neurological disease,
  • Having visual, auditory, and cognitive problems that may prevent participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem University

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (6)

  • Sariibrahim Astepe B, Koleli I. Translation, cultural adaptation, and validation of Australian pelvic floor questionnaire in a Turkish population. Eur J Obstet Gynecol Reprod Biol. 2019 Mar;234:71-74. doi: 10.1016/j.ejogrb.2019.01.004. Epub 2019 Jan 14.

    PMID: 30665079RESULT

  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

    PMID: 10782451RESULT

  • https://doi.org/10.1080/24750573.2017.1322672

    RESULT

  • Horn-Hofmann C, Scheel J, Dimova V, Parthum A, Carbon R, Griessinger N, Sittl R, Lautenbacher S. Prediction of persistent post-operative pain: Pain-specific psychological variables compared with acute post-operative pain and general psychological variables. Eur J Pain. 2018 Jan;22(1):191-202. doi: 10.1002/ejp.1115. Epub 2017 Sep 20.

    PMID: 28940665RESULT

  • Lautenbacher S, Huber C, Kunz M, Parthum A, Weber PG, Griessinger N, Sittl R. Hypervigilance as predictor of postoperative acute pain: its predictive potency compared with experimental pain sensitivity, cortisol reactivity, and affective state. Clin J Pain. 2009 Feb;25(2):92-100. doi: 10.1097/AJP.0b013e3181850dce.

    PMID: 19333152RESULT

  • Ghezzi F, Uccella S, Cromi A, Siesto G, Serati M, Bogani G, Bolis P. Postoperative pain after laparoscopic and vaginal hysterectomy for benign gynecologic disease: a randomized trial. Am J Obstet Gynecol. 2010 Aug;203(2):118.e1-8. doi: 10.1016/j.ajog.2010.04.026. Epub 2010 Jun 3.

    PMID: 20522410RESULT

Related Links

Study Officials

  • Semiha Yenişehir

    Ordu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD, Assist. Prof. Dr.

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 15, 2025

Study Start

October 1, 2025

Primary Completion

February 5, 2026

Study Completion

February 26, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

TU(1)