Education in Patients With Persistent Pelvic Pain
Primary Purpose
Pain, Dysfunction Sexual
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Workshops
Online-accessed material
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Workshops
Online-accessed material
Control group
Arm Description
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.
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.
This group will initially no recieve an intervention and will serve as a control group.
Outcomes
Primary Outcome Measures
Numerical Rating Scale
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
Visual Analogue Scale
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
Secondary Outcome Measures
Pain Catastrophizing Scale
Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome
Survey of Pain Attitudes
Instrument to understand the pain-related beliefs of your chronic pain patients. Minimum value 0, maximum value 285. Higher scores mean better results
Female Sexual Function Index
Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning
Socioeconomic Status Questionnaire
Measurement that determines the participant's social and economic status
Full Information
NCT ID
NCT05114473
First Posted
October 25, 2021
Last Updated
March 21, 2022
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT05114473
Brief Title
Education in Patients With Persistent Pelvic Pain
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Dysfunction Sexual
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups receiving intervention and one serving as control
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Workshops
Arm Type
Experimental
Arm Description
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.
Arm Title
Online-accessed material
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will initially no recieve an intervention and will serve as a control group.
Intervention Type
Other
Intervention Name(s)
Workshops
Intervention Description
Several face-to-face workshops given by a researcher
Intervention Type
Other
Intervention Name(s)
Online-accessed material
Intervention Description
Access to a website containing the educational program
Primary Outcome Measure Information:
Title
Numerical Rating Scale
Description
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
Time Frame
1 week
Title
Visual Analogue Scale
Description
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Scale
Description
Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome
Time Frame
1 week
Title
Survey of Pain Attitudes
Description
Instrument to understand the pain-related beliefs of your chronic pain patients. Minimum value 0, maximum value 285. Higher scores mean better results
Time Frame
1 week
Title
Female Sexual Function Index
Description
Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning
Time Frame
1 week
Title
Socioeconomic Status Questionnaire
Description
Measurement that determines the participant's social and economic status
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Education in Patients With Persistent Pelvic Pain
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