Long-Term Effectiveness of Pain Neuroscience Education in Women With Genito-Pelvic Pain/Penetration Disorder.

NCT07463066 | Completed

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

Brief Summary

The goal of this observational follow-up study is to learn whether the benefits of Pain Neuroscience Education are maintained five years after the original intervention in women previously diagnosed with Genito-Pelvic Pain/Penetration Disorder who participated in a randomized controlled trial. The main questions it aims to answer are: Are improvements in pain intensity maintained five years after the intervention? Are improvements in sexual function and pain-related disability sustained over time? Researchers will compare participants according to the treatment group to which they were originally assigned in the randomized controlled trial to evaluate long-term differences in outcomes. Participants will: Complete questionnaires assessing pain intensity, sexual function, and pain-related outcomes. Undergo follow-up assessments similar to those performed during the original study.

Conditions

Genito-Pelvic Pain/Penetration Disorder

Keywords

Pain; Pelvic pain; Dysfunction sexual

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale

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

  Baseline

Secondary Outcomes (3)

• Pain Catastrophizing Scale

  Baseline

• Survey of Pain Attitudes

  Baseline

• Female Sexual Function Index

  Baseline

Study Arms (3)

In person workshops

This group will attend in person 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: In person workshops

Online-accessed material

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

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

Interventions

Online-accessed material OTHER

Access to a website containing the educational program

Online-accessed material

In person workshops OTHER

Several in person workshops given by a researcher

In person workshops

Eligibility Criteria

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

Study Population

Study participants will be selected from the cohort of women previously enrolled in a randomized controlled trial evaluating Pain Neuroscience Education for Genito-Pelvic Pain/Penetration Disorder. The source population consists of adult women diagnosed with Genito-Pelvic Pain/Penetration Disorder who were originally recruited from clinical settings for the parent study. Eligible participants are women aged 18 years or older who are able to read and understand Spanish and provide informed consent. The population includes individuals with varying demographic and clinical characteristics, such as age, marital status, duration of symptoms, pain severity, and baseline functional status. All participants completed the original intervention protocol and will be contacted for long-term follow-up assessment.

You may qualify if:

• \- Patients over 18 years-old suffering from pelvic pain for more than 6 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 Physiotherapy. University of Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Pain; Pelvic Pain; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)