Efficacy of Pain Neuroscience Education in Genito-Pelvic Pain/Penetration Disorder. A Randomized Controlled Trial.

NCT05114473 | Completed Results

• 1 other identifier: UV-INV_ETICA-1741806
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Patients suffering pelvic persistent pain deal with significant pain that affects their quality of life. Often, conservative treatment interventions are scarce for these patients and are therefore not considered. Education has been developed as a relevant tool in the treatment of patients who suffer from chronic pain or any other pain processing alterations, and has the potential to become a powerfull treatment alternative.

Conditions

Pain; Dysfunction Sexual

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome

  Baseline to week 4

Secondary Outcomes (3)

• Pain Catastrophizing Scale

  Baseline to week 4

• Survey of Pain Attitudes

  Baseline to week 4

• Female Sexual Function Index

  Baseline to week 4

Study Arms (3)

Workshops

EXPERIMENTAL

This group will attend face-to-face workshops were the educational program will be developed. These workshops will be available in several sites, and specific care providers will be assigned for each of these sites.

Other: Workshops

Online-accessed material

EXPERIMENTAL

This group will be granted online access to a platform were the educational program will be uploaded. They will be given autonomy regarding when to enter the platform and view the content.

Other: Online-accessed material

Control group

NO INTERVENTION

This group will initially no recieve an intervention and will serve as a control group.

Interventions

Workshops OTHER

Several face-to-face workshops given by a researcher

Workshops

Online-accessed material OTHER

Access to a website containing the educational program

Online-accessed material

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years-old suffering from dyspareunia for more than 3 months

You may not qualify if:

• Patients suffering from a previous medical condition that explains logically the presence of pain

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physical Therapy

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Pain; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases

Limitations and Caveats

No limitations or caveats were found

Results Point of Contact

• Title: Dr. Borja Perez-Dominguez
• Organization: University of Valencia

f.borja.perez@uv.es

697464680

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants can't be blinded to allocation, but are strongly inculcated not to disclose the allocation their status at the follow up assessments. Care providers will be different from outcome assessors and will be both blinded by an external investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two groups receiving intervention and one serving as control

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 10, 2021
• Study Start: December 10, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 21, 2022
• Last Updated: April 10, 2025
• Results First Posted: May 23, 2024

Record last verified: 2025-04

Locations

ES (1)