Pain, Dysfunction Sexual
Conditions
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.
Interventions
OTHERWorkshops
Several face-to-face workshops given by a researcher
Access to a website containing the educational program
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, 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.
Intervention model description
Two groups receiving intervention and one serving as control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | Baseline to week 4 | Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale | Baseline to week 4 | Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome |
| Survey of Pain Attitudes | 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 |
| Female Sexual Function Index | Baseline to week 4 | Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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 | 29 |
| Control Group This group will initially no recieve an intervention and will serve as a control group. | 22 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Workshops | Online-accessed Material | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 13.2 | 31.6 years STANDARD_DEVIATION 6.9 | 33.0 years STANDARD_DEVIATION 9.1 | 32.8 years STANDARD_DEVIATION 9.5 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 29 Participants | 22 Participants | 69 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Visual Analogue Scale
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
Time frame: Baseline to week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Workshops | Visual Analogue Scale | Pre | 5.3 score on a scale | Standard Deviation 2.5 |
| Workshops | Visual Analogue Scale | Post | 3.8 score on a scale | Standard Deviation 2.4 |
| Online-accessed Material | Visual Analogue Scale | Pre | 5.8 score on a scale | Standard Deviation 2 |
| Online-accessed Material | Visual Analogue Scale | Post | 4.9 score on a scale | Standard Deviation 2.5 |
| Control Group | Visual Analogue Scale | Pre | 5.1 score on a scale | Standard Deviation 1.8 |
| Control Group | Visual Analogue Scale | Post | 4.9 score on a scale | Standard Deviation 2.2 |
Secondary
Female Sexual Function Index
Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning
Time frame: Baseline to week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Workshops | Female Sexual Function Index | Pre | 18.9 score on a scale | Standard Deviation 7.8 |
| Workshops | Female Sexual Function Index | Post | 21.0 score on a scale | Standard Deviation 9.5 |
| Online-accessed Material | Female Sexual Function Index | Pre | 19.1 score on a scale | Standard Deviation 7.3 |
| Online-accessed Material | Female Sexual Function Index | Post | 20.8 score on a scale | Standard Deviation 8.1 |
| Control Group | Female Sexual Function Index | Pre | 19.5 score on a scale | Standard Deviation 7.1 |
| Control Group | Female Sexual Function Index | Post | 18.4 score on a scale | Standard Deviation 9.3 |
Secondary
Pain Catastrophizing Scale
Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome
Time frame: Baseline to week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Workshops | Pain Catastrophizing Scale | Pre | 25.2 score on a scale | Standard Deviation 12.7 |
| Workshops | Pain Catastrophizing Scale | Post | 18.9 score on a scale | Standard Deviation 12.6 |
| Online-accessed Material | Pain Catastrophizing Scale | Pre | 28.0 score on a scale | Standard Deviation 10.4 |
| Online-accessed Material | Pain Catastrophizing Scale | Post | 20.4 score on a scale | Standard Deviation 11.5 |
| Control Group | Pain Catastrophizing Scale | Pre | 22.4 score on a scale | Standard Deviation 7.5 |
| Control Group | Pain Catastrophizing Scale | Post | 25.3 score on a scale | Standard Deviation 8.2 |
Secondary
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
Time frame: Baseline to week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Workshops | Survey of Pain Attitudes | Pre | 45.1 score on a scale | Standard Deviation 10.6 |
| Workshops | Survey of Pain Attitudes | Post | 45.2 score on a scale | Standard Deviation 14.5 |
| Online-accessed Material | Survey of Pain Attitudes | Pre | 49.6 score on a scale | Standard Deviation 13.1 |
| Online-accessed Material | Survey of Pain Attitudes | Post | 50.9 score on a scale | Standard Deviation 14.8 |
| Control Group | Survey of Pain Attitudes | Pre | 52.4 score on a scale | Standard Deviation 13 |
| Control Group | Survey of Pain Attitudes | Post | 52.4 score on a scale | Standard Deviation 13.6 |