NCT03393910

Brief Summary

The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable pain

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

January 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

January 3, 2018

Last Update Submit

July 27, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Score: A change of 13mm

    ale from 0-10, measured in mm. A change from baseline of 13mm is considered a significant change

    Within 1 hour of the exam

Secondary Outcomes (3)

  • Wellbeing quality of life score: Range 0-4

    Within 1 hour of the exam

  • Rosenberg Self-esteem Score: Scale 10-40

    Within 1 hour of the exam

  • Female Sexual Function Index-19

    Within 1 hour of the exam

Study Arms (2)

Observational

NO INTERVENTION

Normal pelvic exam exposures: External exam followed by speculum exam, followed by bimanual exam

Experimental Pelvic Exam

ACTIVE COMPARATOR

Changing the order of the pelvic exam Intervention: External exam, bimanual exam,speculum exam

Diagnostic Test: Experimental Pelvic Exam

Interventions

Experimental Pelvic ExamDIAGNOSTIC_TEST

The pelvic exam will be completed in the following order: external, speculum, bimanual exam in the "standard" group. In the Experimental group the pelvic exam will be done with external xam, bimanual exam then speculum exam.

Experimental Pelvic Exam

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English Speaking Are able to read and write English Are utilizing outpatient services and being seen for a first appointment at an outpatient Vulvodynia Center

You may not qualify if:

  • Non English Speaking
  • Patients who cannot read or write
  • Those who are pregnant
  • Those who do not have a chronic vulvovaginal condition
  • Patients other than "new" patients
  • Patients who would not otherwise need a speculum exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel Ob/Gyn

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (18)

  • Williams AA, Williams M. A guide to performing pelvic speculum exams: a patient-centered approach to reducing iatrogenic effects. Teach Learn Med. 2013;25(4):383-91. doi: 10.1080/10401334.2013.827969.

    PMID: 24112210BACKGROUND

  • Hilden M, Sidenius K, Langhoff-Roos J, Wijma B, Schei B. Women's experiences of the gynecologic examination: factors associated with discomfort. Acta Obstet Gynecol Scand. 2003 Nov;82(11):1030-6. doi: 10.1034/j.1600-0412.2003.00253.x.

    PMID: 14616277BACKGROUND

  • Wijma B, Gullberg M, Kjessler B. Attitudes towards pelvic examination in a random sample of Swedish women. Acta Obstet Gynecol Scand. 1998 Apr;77(4):422-8.

    PMID: 9598951BACKGROUND

  • Bernet R, Buddeberg C. [Physician-patient relations in gynecology: expectations and experiences of patients]. Gynakol Geburtshilfliche Rundsch. 1994;34(1):43-9. doi: 10.1159/000272333. German.

    PMID: 8019173BACKGROUND

  • Daley AM, Cromwell PF. How to perform a pelvic exam for the sexually active adolescent. Nurse Pract. 2002 Sep;27(9):28, 31-2, 34, 37-9, 43; quiz 44-5. doi: 10.1097/00006205-200209000-00006.

    PMID: 12352766BACKGROUND

  • Primrose RB. Taking the tension out of pelvic exams. Am J Nurs. 1984 Jan;84(1):72-4. No abstract available.

    PMID: 6559035BACKGROUND

  • Nyirjesy P, Peyton C, Weitz MV, Mathew L, Culhane JF. Causes of chronic vaginitis: analysis of a prospective database of affected women. Obstet Gynecol. 2006 Nov;108(5):1185-91. doi: 10.1097/01.AOG.0000239103.67452.1a.

    PMID: 17077241BACKGROUND

  • Goetsch MF, Lim JY, Caughey AB. Locating pain in breast cancer survivors experiencing dyspareunia: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1231-1236. doi: 10.1097/AOG.0000000000000283.

    PMID: 24807329BACKGROUND

  • Dargie EE, Chamberlain SM, Pukall CF. Provoked Vestibulodynia: Diagnosis, Self-Reported Pain, and Presentation During Gynaecological Examinations. J Obstet Gynaecol Can. 2017 Mar;39(3):145-151. doi: 10.1016/j.jogc.2017.01.001.

    PMID: 28343555BACKGROUND

  • Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.

    PMID: 11354213BACKGROUND

  • Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.

    PMID: 9835471BACKGROUND

  • Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-132. doi: 10.1016/S0304-3959(01)00371-2. No abstract available.

    PMID: 11690725BACKGROUND

  • Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.

    PMID: 8604867BACKGROUND

  • Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.

    PMID: 11719741BACKGROUND

  • Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, NJ: Princeton University Press.

    BACKGROUND

  • Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005 Jan-Feb;31(1):1-20. doi: 10.1080/00926230590475206.

    PMID: 15841702BACKGROUND

  • 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: 10782451BACKGROUND

  • Rinko R, Spector C, Cook E, Mancenido B, Gracely EJ, Nyirjesy P. Sequence of Pelvic Examination Does Not Affect Patients With Baseline Vulvovaginal Syndromes: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):e45-e51. doi: 10.1097/SPV.0000000000000791.

    PMID: 32332423DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Rebecca Rinko

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 9, 2018

Study Start

January 22, 2018

Primary Completion

July 16, 2018

Study Completion

July 16, 2018

Last Updated

July 30, 2018

Record last verified: 2018-07

Locations

US(1)