Trial Outcomes & Findings for Efficacy of Pain Neuroscience Education in Genito-Pelvic Pain/Penetration Disorder. A Randomized Controlled Trial. (NCT NCT05114473)

NCT ID: NCT05114473

Last Updated: 2025-04-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 69 participants
• Primary outcome timeframe: Baseline to week 4
• Results posted on: 2025-04-10

Participant Flow

Participant milestones

Measure	Workshops 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. Workshops: Several face-to-face workshops given by a researcher	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. Online-accessed material: Access to a website containing the educational program	Control Group This group will initially no recieve an intervention and will serve as a control group.
Overall Study STARTED	18	29	22
Overall Study COMPLETED	16	27	22
Overall Study NOT COMPLETED	2	2	0

Reasons for withdrawal

Measure	Workshops 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. Workshops: Several face-to-face workshops given by a researcher	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. Online-accessed material: Access to a website containing the educational program	Control Group This group will initially no recieve an intervention and will serve as a control group.
Overall Study Lost to Follow-up	2	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Workshops n=18 Participants 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. Workshops: Several face-to-face workshops given by a researcher	Online-accessed Material n=29 Participants 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. Online-accessed material: Access to a website containing the educational program	Control Group n=22 Participants This group will initially no recieve an intervention and will serve as a control group.	Total n=69 Participants Total of all reporting groups
Age, Continuous	34.5 years STANDARD_DEVIATION 13.2 • n=18 Participants	31.6 years STANDARD_DEVIATION 6.9 • n=29 Participants	33.0 years STANDARD_DEVIATION 9.1 • n=22 Participants	32.8 years STANDARD_DEVIATION 9.5 • n=69 Participants
Sex: Female, Male Female	18 Participants n=18 Participants	29 Participants n=29 Participants	22 Participants n=22 Participants	69 Participants n=69 Participants
Sex: Female, Male Male	0 Participants n=18 Participants	0 Participants n=29 Participants	0 Participants n=22 Participants	0 Participants n=69 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline to week 4

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

Outcome measures

Measure	Workshops n=16 Participants 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. Workshops: Several face-to-face workshops given by a researcher	Online-accessed Material n=27 Participants 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. Online-accessed material: Access to a website containing the educational program	Control Group n=22 Participants This group will initially no recieve an intervention and will serve as a control group.
Visual Analogue Scale Pre	5.3 score on a scale Standard Deviation 2.5	5.8 score on a scale Standard Deviation 2.0	5.1 score on a scale Standard Deviation 1.8
Visual Analogue Scale Post	3.8 score on a scale Standard Deviation 2.4	4.9 score on a scale Standard Deviation 2.5	4.9 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline to week 4

Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome

Outcome measures

Measure	Workshops n=16 Participants 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. Workshops: Several face-to-face workshops given by a researcher	Online-accessed Material n=27 Participants 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. Online-accessed material: Access to a website containing the educational program	Control Group n=22 Participants This group will initially no recieve an intervention and will serve as a control group.
Pain Catastrophizing Scale Pre	25.2 score on a scale Standard Deviation 12.7	28.0 score on a scale Standard Deviation 10.4	22.4 score on a scale Standard Deviation 7.5
Pain Catastrophizing Scale Post	18.9 score on a scale Standard Deviation 12.6	20.4 score on a scale Standard Deviation 11.5	25.3 score on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: Baseline to week 4

Instrument to understand the pain-related beliefs of your chronic pain patients. Minimum value 0, maximum value 285. Higher scores mean better results

Outcome measures

Measure	Workshops n=16 Participants 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. Workshops: Several face-to-face workshops given by a researcher	Online-accessed Material n=27 Participants 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. Online-accessed material: Access to a website containing the educational program	Control Group n=22 Participants This group will initially no recieve an intervention and will serve as a control group.
Survey of Pain Attitudes Post	45.2 score on a scale Standard Deviation 14.5	50.9 score on a scale Standard Deviation 14.8	52.4 score on a scale Standard Deviation 13.6
Survey of Pain Attitudes Pre	45.1 score on a scale Standard Deviation 10.6	49.6 score on a scale Standard Deviation 13.1	52.4 score on a scale Standard Deviation 13.0

SECONDARY outcome

Timeframe: Baseline to week 4

Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning

Outcome measures

Measure	Workshops n=16 Participants 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. Workshops: Several face-to-face workshops given by a researcher	Online-accessed Material n=27 Participants 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. Online-accessed material: Access to a website containing the educational program	Control Group n=22 Participants This group will initially no recieve an intervention and will serve as a control group.
Female Sexual Function Index Pre	18.9 score on a scale Standard Deviation 7.8	19.1 score on a scale Standard Deviation 7.3	19.5 score on a scale Standard Deviation 7.1
Female Sexual Function Index Post	21.0 score on a scale Standard Deviation 9.5	20.8 score on a scale Standard Deviation 8.1	18.4 score on a scale Standard Deviation 9.3

Adverse Events

Workshops

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Online-accessed Material

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Borja Perez-Dominguez

University of Valencia

Phone: 697464680

Email: f.borja.perez@uv.es

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place