Validation of Patient Reported Outcome Measures for Use in Vulvodynia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03770169

Enrollment

Registered

2018-12-10

Start date

2019-02-18

Completion date

2019-09-19

Last updated

2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvodynia

Brief summary

The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Fluent in understanding, speaking and reading US-English * Have vulvodynia with pain for at least 6 months

Exclusion criteria

* Clinically significant history of alcohol/drug abuse or dependence within the last 2 years

Design outcomes

Primary

Measure	Time frame	Description
Validation of mVPAQ	1 week	Cognitive debrief and usability through interviews and completion of an electronic diary
Validation of mFSFI	1 week	Cognitive debrief and usability through interviews and completion of an electronic diary
Validation of Pain on Intercourse Numeric Rating Scale (NRS)	1 week	Cognitive debrief and usability through interviews and completion of an electronic diary. Pain on Intercourse NRS that describes pain experienced during this sexual intercourse episode by number. The higher is the number the worse is pain.

Secondary

Measure	Time frame	Description
Vulvar pain NRS	1 week	Assess understanding of the appropriateness of the vulvar pain NRS through interview and completion of an electronic diary

Countries

United States

Outcome results