Repetitive Thinking in Fibromyalgia (PRFM-3)
|ClinicalTrials.gov Identifier: NCT03964285|
Recruitment Status : Completed
First Posted : May 28, 2019
Last Update Posted : July 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Rumination Fibromyalgia Chronic Pain Repetitive Negative Thinking||Other: rumination induction Other: distraction induction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of Rumination on Affectivity After Physical Activity in Fibromyalgia|
|Actual Study Start Date :||February 26, 2019|
|Actual Primary Completion Date :||February 25, 2020|
|Actual Study Completion Date :||February 25, 2020|
Active Comparator: Rumination group
The patients will receive rumination induction. Rumination induction will follow a relevant activity for our patients: climbing steps. Rumination induction will be done right after climbing the steps.
Other: rumination induction
The induction method is based on specific instructions given to participants on how to focus on different elements of their experience. For example, they will be led, in the rumination condition, to reflect on the causes, meanings and consequences of the amount of tension they feel in their muscles.
Experimental: distraction group
Distraction will follow a relevant activity for our patients: climbing steps. Distraction induction will be done right after climbing the steps.
Other: distraction induction
The induction method is based on specific instructions given to participants on how to focus on different elements of their experience. In the distraction condition they will, for example, imagine a ship crossing the Atlantic.
- Change in PANAS score before and after induction phase [ Time Frame: One hour and twenty minutes after inclusion of the patients ]The PANAS Scale or Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire. The list is split up into two segments, or mood scales. One scale measures a person's positive emotion and the other scale measures the negative. Each segment has ten terms, which can be rated on a scale of 1 to 5 to indicate the extent to which the respondent agrees that this applies to him.Characteristic of this test is the fact that it can be completed in 10 minutes. High score is associated with stress and anxiety. small score is associated with calm.
- Change in VAS score before and after induction phase [ Time Frame: One hour and twenty minutes after inclusion of the patients ]The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain, anxiety, depression, etc. 0 would mean "no pain" and 10 would mean "worst possible pain."
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964285
|Amiens, France, 80054|
|Principal Investigator:||Eric Serra, MD||CHU Amiens|
|Principal Investigator:||Virginie Marechal, MD||CHU Amiens|
|Principal Investigator:||Alain DERVAUX, MD||CHU Amiens|
|Principal Investigator:||Jérémy Fonseca Das Neves, PhD||CHU Amiens|
|Principal Investigator:||Stéphane Rusinek, PHD||Lille University|