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

NCT05637502 | Completed

• 1 other identifier: UV-INV_ETICA-2678233
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Genito-Pelvic Pain/Penetration Disorder

Keywords

Genito-Pelvic Pain/Penetration Disorder; Pelvic pain; Dyspareunia; Graded Motor Imagery; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• 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

  6 weeks

• Sexual function

  Sexual function 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.

  6 weeks

Study Arms (2)

Graded Motor Imagery

EXPERIMENTAL

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

Other: Graded Motor Imagery

Control

NO INTERVENTION

Participants initially receiving no intervention at all.

Interventions

Graded Motor Imagery 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.

Graded Motor Imagery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women diagnosed with persistent pelvic pain
• Pain suffered for a period of a minimum of 3 months
• Adult (\>18 years) women

You may not qualify if:

• Medical condition that logically explains the presence of pain
• Pain suffered for a period of less than 3 months

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Pelvic Pain; Dyspareunia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: June 1, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 22, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)