The effect of Hypnosis in patients with persistent pain related to Fibromyalgia
- Conditions
- fibromyalgiachronic painC05.651
- Registration Number
- RBR-54zyxsk
- Lead Sponsor
- Clinica Ortopédica e Traumatologica S/A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
volunteers with fibromyalgia; both sexes; age between 18 and 60 years; and moderate to severe chronic pain for at least 6 months; on stable analgesic treatment for chronic pain management for more than 1 month at the time of study enrollment
Patients who are not able to understand the informed consent;who have been treated with hypnosis before or are participating in another clinical trial; and with cognitive impairment of any kind; and with chronic pain caused by other medical condictions and previous surgical procedures that may affect the study's efficacy evaluations; with a a history or current of severe psychopathologies (severe depression, schizophrenia, psychosis, etc.) or undergoing treatment with psychotherapy; using opioids in schema not stable as defined by the protocol;and who have undergone any type of surgery whithin 6 months of study entry.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the change in pain intensity after treatment and in the long term by comparing pain intensity with baseline using the Numerical Pain Scale (END) tool
- Secondary Outcome Measures
Name Time Method Quality of Life assessed by the WHOQOL-BRIEF questionnaire;Assessment of casttrophic thoughts and association of catastrophism with the Pain-Associated Catastrophism Scale (B-PCS);Assess the intensity of pain unpleasantness using the numerical scale (ENDD);Assess the quality and intensity of pain (sensory and affective) using the Short Form McGill Pain Questionnaire (SF-MGQ)?;Assess sleep quality, as assessed by the Pittsburgh Sleep Quality Index (PSQI-BR)?;Assess anxiety and depression assessed by the HADS tool score?