Education in Patients With Persistent Pelvic Pain

• Sponsor: University of Valencia (Other)
• Overall Status: Completed
• CT.gov ID: NCT05114473
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 3
• Actual Duration (Months): 3.3
• Patients Per Site Per Month: 20.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Dysfunction Sexual	Other: Workshops; Other: Online-accessed material	N/A

Detailed Description

In this intervention, the effects of implementing educational programs in patients suffering from pelvic persistent pain will be assessed.

Patients with pelvic persistent pain have both problems directly related with their pain and other issues that appear derived from suffering pain over a determined period, such as alterations in the sexuality or overall quality of life. Facing these patients is a challenge for professionals, and many can't find the treatment that properly fits the patient's clinical presentation.

Education, and educating patients on their problem, is an exponentially growing alternative used in Physical Therapy involving patients who suffer from a dysfunctional pain, chronic pain, or any kind of pain presentation that affects the patient's well-being.

This study will assess firstly if the implementation of a pain-related education program is relevant in the treatment of pelvic persistent pain, and will further observe which modality (presential workshops or online-accessed material) is the most effective involving adherence and improvement.

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two groups receiving intervention and one serving as controlTwo groups receiving intervention and one serving as control
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Educational Program Interventions for Patients Suffering From Persistent Pelvic Pain and Their Effects Over Pain and Functionality. A Multi-centered Randomized Clinical Trial.
• Actual Study Start Date: Dec 10, 2021
• Actual Primary Completion Date: Feb 28, 2022
• Actual Study Completion Date: Mar 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Workshops; Several face-to-face workshops given by a researcher
Experimental: 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; Access to a website containing the educational program
No Intervention: Control group This group will initially no recieve an intervention and will serve as a control group.

Outcome Measures

Primary Outcome Measures

1. Numerical Rating Scale [1 week]

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

2. Visual Analogue Scale [1 week]

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

Secondary Outcome Measures

1. Pain Catastrophizing Scale [1 week]

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

2. Survey of Pain Attitudes [1 week]

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

3. Female Sexual Function Index [1 week]

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

4. Socioeconomic Status Questionnaire [1 week]

   Measurement that determines the participant's social and economic status

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Physical Therapy	Valencia		Spain	46010

Sponsors and Collaborators

• University of Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: José Casaña Granell, Dr., University of Valencia
• ClinicalTrials.gov Identifier: NCT05114473
• Other Study ID Numbers: Persistent Pelvic Pain
• First Posted: Nov 10, 2021
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pelvic Pain

Study Results

No Results Posted as of Mar 22, 2022