Vaginal SurgeryNCT07065188
Effect of Pain Vigilance on Pain, Bladder-Bowel Function and Sexual Life
An observational study of Vaginal Surgery, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Vaginal Surgery
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 26 Feb 2026
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Have undergone vaginal surgery
Who may be able to join
- Being aged 18-40.
- Being able to read and write Turkish.
- Have undergone vaginal surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pain Vigilance on Pain Catastrophizing, Bladder-Bowel Function and Sexual Life: A Comparative Study of Before-After Vaginal Surgery
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.
Read the detailed description
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
- Vaginal Surgery
- Keywords
- Vaginal surgery, pain vigilance, sexual function
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and first day of after surgery (first postoperative day)
Secondary outcomes (4)
Pain Catastrophizing Scale
This scale was developed to measure the exaggerated negative mental reaction of individuals to existing or anticipated painful experiences and the extent to which they catastrophize pain. The validity and reliability of the Turkish version of the scale was demonstrated. It consists of 13 items, and each item is scored as never=0, slightly=1, moderately=2, greatly=3 and always=4. A high total score indicates a high degree of catastrophizing pain.
Measured: Before and first day of after surgery (first postoperative day)
Australian Pelvic Floor Questionnaire
The Turkish version of the APFQ was shown to be valid and reliable. The scale assessing pelvic floor function has subheadings of bladder, bowel, prolapse, and sexual function. The total score ranges from 0-40. The high score indicates that severity of symptoms is high and poor sexual function.
Measured: Before and after eight weeks of vaginal surgery
Female Sexual Function Index
FSFI was developed to assess sexual function in women. It was shown to be reliable and valid in Turkish with 19 questions. There are six sub-dimensions of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each item is scored on a 0-5 scale. An increase in the total score indicates an improvement in sexual function; an increase in the score in the pain parameter indicates a decrease in pain sensation. The scale score ranges from 2-36. The cut-off value is 26.5 to define sexual dysfunction.
Measured: Before and after eight weeks of vaginal surgery
Visual Analog Scale
Post-operative pain intensity during urination and defecation will be assessed with a 0-10 cm VAS before discharge. Duration of pain and factors that increased and decreased pain will recorded. The duration of first micturition, defecation, and first passing gas in the postoperative period will recorded.
Measured: Before and first day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Oct 2025
- Primary completion5 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vaginal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semiha Yenişehir, Ordu University
- Investigators
- Semiha Yenişehir, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065188
- Sponsor's protocol ID
- 2025 06/254
- Status last verified
- Feb 2026
- First submitted
- 30 Jun 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30665079Rosen 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.
PubMed 10782451https://doi.org/10.1080/24750573.2017.1322672
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.
PubMed 28940665Lautenbacher 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.
PubMed 19333152Ghezzi 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.
PubMed 20522410
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pain Vigilance on Pain Catastrophizing, Bladder-Bowel Function and Sexual Life: A Comparative Study of Before-After Vaginal Surgery
- ClinicalTrials.gov ID
- NCT07065188
- Acronym / sponsor ID
- 2025 06/254
- Conditions
- Vaginal Surgery
- Keywords
- Vaginal surgery, pain vigilance, sexual function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Have undergone vaginal surgery
Key inclusion criteria (3 listed)
- Being aged 18-40.
- Being able to read and write Turkish.
- Have undergone vaginal surgery.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Vigilance and Awareness Questionnaire
Time frame: Before and first day of after surgery (first postoperative day)
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.
4 secondary outcomes
Pain Catastrophizing Scale
Time frame: Before and first day of after surgery (first postoperative day)
Australian Pelvic Floor Questionnaire
Time frame: Before and after eight weeks of vaginal surgery
Female Sexual Function Index
Time frame: Before and after eight weeks of vaginal surgery
Visual Analog Scale
Time frame: Before and first day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Results publication: PubMed 30665079Sariibrahim 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.
- Results publication: PubMed 10782451Rosen 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.
- Results publicationhttps://doi.org/10.1080/24750573.2017.1322672
- Results publication: PubMed 28940665Horn-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.
- Results publication: PubMed 19333152Lautenbacher 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.
- Results publication: PubMed 20522410Ghezzi 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semiha Yenişehir principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Surgery, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Vigilance and Awareness Questionnaire (time frame: Before and first day of after surgery (first postoperative day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07065188, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.