Effect of Pain Vigilance on Pain, Bladder-Bowel Function and Sexual Life

NCT ID: NCT07065188

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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Hypervigilance is the state of being consciously alert to external stimuli. Specific attention to pain or other somatosensory stimuli is defined as "specific hypervigilance". Hypervigilance is a strong indicator of subjective acute postoperative pain and contributes significantly to the prediction of post-operative pain. A cautious bias toward positive preoperative stimuli may predispose patients to postoperative pain, indicating a maladaptive coping method. Pain-related disability occurs in patients with a high level of pain hypervigilance before surgery. Urinary and bowel functions are impaired after vaginal surgery and bladder-bowel dysfunction is observed. Sexual function is also affected positively or negatively after vaginal surgery. The causes of sexual dysfunction after vaginal surgery are classified as organic, emotional and psychological. Decreased pelvic blood flow may cause vaginal dryness and dyspareunia by causing vaginal smooth muscle fibrosis.

This study was planned to evaluate the effect of preoperative pain hypervigilance on post-operative pain, bladder-bowel symptoms and sexual life in women undergoing vaginal surgery and to compare these parameters before and after surgery. Physical and sociodemographic, obstetric and clinical characteristics will be recorded. Pain, bladder-bowel and sexual function will be evaluated before and after surgery. The pain trigger status of the subjects will be assessed with the PVAQ, the degree to which they catastrophize pain will be assessed with the PCS and their sexual function will be assessed with the FSFI . The AOFQ will be used to assess bladder-bowel function. Postoperative pain intensity during urination and defecation will be evaluated with Visual Analog Scale.

Conditions

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Vaginal Surgery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ordu University

OTHER

Sponsor Role lead

Responsible Party

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Semiha Yenişehir

PT, PhD, Assist. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 30665079 (View on PubMed)

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.

Reference Type RESULT
PMID: 10782451 (View on PubMed)

https://doi.org/10.1080/24750573.2017.1322672

Reference Type 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.

Reference Type RESULT
PMID: 28940665 (View on PubMed)

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.

Reference Type RESULT
PMID: 19333152 (View on PubMed)

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.

Reference Type RESULT
PMID: 20522410 (View on PubMed)

Related Links

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Other Identifiers

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2025 06/254

Identifier Type: -

Identifier Source: org_study_id

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