An interventional study of body-scan meditation and Psychological evaluation in Parkinson's Disease, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-17.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other
The aim of the study is to constitute a proof of concept study for a larger study investigating the effect of mindfulness on anxiety and agitation in Parkinson's disease (PD) based on the results of a preliminary feasibility.
Neuropsychiatric and behavioral non motor symptoms are common in PD often requiring hospitalization and/or specific drug management. Mindfulness-based stress reduction (MBSR) programs have proved to be efficacious in PD both for the management of motor and non-motor symptoms. This is however the case only in out-patients and by using standardized 8 weeks programs. The team has experienced in the hospitalization unit that methods derived from the MBSR program such as the "body scan", administered by the paramedical personnel, is of great help for the non-pharmacological management of anxiety and agitation in PD, avoiding physical contention in many cases. Based on this experience the study aims at evaluating the feasibility and preliminary efficacy of a simple and standardized administration of the "body scan" meditation in the management of anxiety and agitation in PD admitted in the unit since less than 48h.
Exclusion Criteria:
Other: body-scan meditation · Diagnostic Test: Psychological evaluation
15 minutes audio-guided body-scan meditation
NPI (Neuropsychiatric symptoms Inventory) - PAS (Parkinson's disease Anxiety Screening Questionnaire) - VAS measuring pain, anxiety and discomfort Before and after "body-scan" meditation
Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission
Time frame: 48 hours after admission
Rate of patient's eligibility and causes of non-eligibility
Time frame: At inclusion (day 0)
Rate of study drop-out
Time frame: through study completion, an average of 1 year
Causes of study drop-outs
by oral questionnaire
Time frame: through study completion, an average of 1 year
Mean delay between admission and first meditation
Time frame: After "body scan" meditation, an average of 48 hours after admission
Cause of failure of meditation administration within 48h
Failure factors: related to staffing (insufficient, untrained...), related to the organization of the service (double room / individual), related to the patient (visits, temporary refusal), related to the equipment (unavailable, non-functional)
Time frame: 48 hours after admission (day 0)
Percentage of improvement pain, anxiety and discomfort
by visual analog scales (VAS)
Time frame: before and after "body scan" meditation, an average of 48 hours after admission
Percentage of improvement at the Parkinson's disease
by Anxiety Screening Questionnaire (PAS)
Time frame: before and after "body scan" meditation, an average of 48 hours after admission
Percentage of improvement at the Parkinson's disease
by the Neuropsychiatric symptoms Inventory (NPI) total scores
Time frame: before and after "body scan" meditation, an average of 48 hours after admission
Plan to share: No
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University Hospital, Bordeaux