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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Workshops | Experimental | 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. |
|
| Online-accessed material | Experimental | 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. |
|
| Control group | No Intervention | This group will initially no recieve an intervention and will serve as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Workshops | Other | Several face-to-face workshops given by a researcher |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome | Baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing Scale | Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome | Baseline to week 4 |
| Survey of Pain Attitudes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy | Valencia | 46010 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Control Group | This group will initially no recieve an intervention and will serve as a control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale | Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 4 |
|
Adverse event data was not collected.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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No limitations or caveats were found
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Borja Perez-Dominguez | University of Valencia | 697464680 | 34 | f.borja.perez@uv.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2021 | Jun 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
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Two groups receiving intervention and one serving as control
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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.
| Online-accessed material |
| Other |
Access to a website containing the educational program |
|
Instrument to understand the pain-related beliefs of your chronic pain patients. Minimum value 0, maximum value 285. Higher scores mean better results
| Baseline to week 4 |
| Female Sexual Function Index | Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning | Baseline to week 4 |
| 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 |
| BG002 | Control Group | This group will initially no recieve an intervention and will serve as a control group. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 | Control Group | This group will initially no recieve an intervention and will serve as a control group. |
|
|
| Secondary | Pain Catastrophizing Scale | Instrument developed quantify an individual's pain experience. Minimum value 0, maximum value 52. Higher scores mean worse outcome | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 4 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 4 |
|
|
|
| Secondary | Female Sexual Function Index | Inventory designed to assess female sexual function. Minimum value 2, maximum value 36. Higher scores mean better functioning | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 4 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Control Group | This group will initially no recieve an intervention and will serve as a control group. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D000091642 | Urogenital Diseases |
| Male |
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|
|