Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder

NCT ID: NCT05637502

Last Updated: 2024-05-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-07-22

Brief Summary

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The goal of this clinical trial is to assess the effects of a Graded Motor Imagery (GMI) programme in women diagnosed with Genito-Pelvic Pain Penetration (GPPD) Disorder.

The main questions it aims to answer are:

Does a GMI programme reduce pain intensity levels in women diagnosed with GPPPD? Does a GMI programme have an effect on sexual function in women diagnosed with 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

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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 and improve sexual function in women diagnosed with Genito-Pelvic Pain Penetration Disorder.

Conditions

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Genito-Pelvic Pain/Penetration Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Graded Motor Imagery

Participants receiving a tailored Graded Motor Imagery program for pelvic pain.

Group Type EXPERIMENTAL

Graded Motor Imagery

Intervention Type OTHER

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.

Control

Participants initially receiving no intervention at all.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Graded Motor Imagery

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

Eligibility Criteria

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Inclusion Criteria

* Women diagnosed with 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Borja Pérez-Domínguez

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Valencia

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UV-INV_ETICA-2678233

Identifier Type: -

Identifier Source: org_study_id

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