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GMI in Women Suffering GPPPD

Primary Purpose

Genito-Pelvic Pain/Penetration Disorder

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Graded Motor Imagery
Education
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genito-Pelvic Pain/Penetration Disorder focused on measuring Genito-Pelvic Pain/Penetration Disorder, Pelvic pain, Dyspareunia, Graded Motor Imagery, Physical Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women suffering from persistent pelvic pain Pain suffered for a period of a minimum of 3 months Adult (>18 years) women Exclusion Criteria: Medical condition that logically explains the presence of pain Pain suffered for a period of less than 3 months Underage women (<18 years)

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Graded Motor Imagery and Education

Education

Arm Description

Participants receiving the Graded Motor Imagery programme and a therapeutic educational program

Participants only receiving a therapeutic educational program

Outcomes

Primary Outcome Measures

Pain Intensity
Pain intensity assessed through a Visual Analogue Scale, with a mininum value of 0 and a maximum value of 10, higher scores mean a worse outcome

Secondary Outcome Measures

Cognitions about vaginal penetration
Cognitions about vaginal penetration assessed through the Vaginal Penetration Cognition Questionnaire (VPCQ). Minimum score is 0, maximum score is 240. Higher scores mean a worse outcome.
Sexual functioning
Sexual Functioning assessed through a short version of the Female Sexual Function Index (FSFI). Minimum score is 6, maximum score is 30. Higher scores mean better outcome.

Full Information

First Posted
November 23, 2022
Last Updated
September 20, 2023
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05637502
Brief Title
GMI in Women Suffering GPPPD
Official Title
Graded Motor Imagery in Women Suffering From Genito-Pelvic Pain Penetration Disorder. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
July 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to assess the effects of a Graded Motor Imagery (GMI) programme in women suffering from Genito-Pelvic Pain Penetration (GPPD) Disorder. The main questions it aims to answer are: Does a GMI programme reduce pain intensity levels in women suffering GPPPD? Does a GMI programme have an effect on other pain-related outcomes in women suffering GPPPD? Participants will undergo a GMI programme and will be tested prior to and after the intervention to assess if the programme has a significant effect with regards to pain intensity and other pain-related outcome
Detailed Description
Graded Motor Imagery has been extensively used in several populations suffering pain-related disorders. It triggers cortical stimulation gradually in order to have an effect on the alterations that might have occured due to pain Women suffering from Genito-Pelvic Pain Penetration Disorder deal with persistent pelvic pain that is no longer responding to a noxious stimulus, therefore this clinical presentation could have several cortical alterations implicated. The main goal of this study is to assess if a Graded Motor Imagery programme is able to reduce pain intensity in women suffering from Genito-Pelvic Pain Penetration Disorder. Secondary objectives will include if this programme also improves pain-related outcomes such as pain catastrophizing or pain-related fear of movement, known as kinesiophobia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genito-Pelvic Pain/Penetration Disorder
Keywords
Genito-Pelvic Pain/Penetration Disorder, Pelvic pain, Dyspareunia, Graded Motor Imagery, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two parallel group, randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Graded Motor Imagery and Education
Arm Type
Experimental
Arm Description
Participants receiving the Graded Motor Imagery programme and a therapeutic educational program
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Participants only receiving a therapeutic educational program
Intervention Type
Other
Intervention Name(s)
Graded Motor Imagery
Intervention Description
Graded Motor Imagery programme consisting on three stages that will be gradually implemented. (i) Implicit Motor Imagery, that will be implemented through a developed app that resembles the Recognize app but adapted for Pelvic Floor disorders, (ii) Explicit Motor Imagery, applied through several sessions of motor imagery assisted through audio recordings and (iii) Graded Exposure, also guided through audio recordings and several practical tasks to perform.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Participants will receive a therapeutic educational programme specifically developed for Genito-Pelvic Pain Penetration Disorder. The programme will include content involving Pelvic Floor anatomy, pain-processing and sexuality discussions.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity assessed through a Visual Analogue Scale, with a mininum value of 0 and a maximum value of 10, higher scores mean a worse outcome
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Cognitions about vaginal penetration
Description
Cognitions about vaginal penetration assessed through the Vaginal Penetration Cognition Questionnaire (VPCQ). Minimum score is 0, maximum score is 240. Higher scores mean a worse outcome.
Time Frame
1 week
Title
Sexual functioning
Description
Sexual Functioning assessed through a short version of the Female Sexual Function Index (FSFI). Minimum score is 6, maximum score is 30. Higher scores mean better outcome.
Time Frame
1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women suffering from persistent pelvic pain Pain suffered for a period of a minimum of 3 months Adult (>18 years) women Exclusion Criteria: Medical condition that logically explains the presence of pain Pain suffered for a period of less than 3 months Underage women (<18 years)
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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GMI in Women Suffering GPPPD

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