Clinical trial NCT03349554: A Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients
Official title: An Exploratory Study of the Feasibility of the Installation by a Paramedical Staff of a Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
anxiety
meditation
in-patients
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* Age over 18
* Admitted in the unit since less than 3 days
* Presenting at least 3 symptoms with a severity rated \> 2 at the Hamilton anxiety scale (HAM-A)
* Patients with social security insurance
* Informed consent signed

Exclusion Criteria:

* Dementia, delusions or hallucination not permitting an informed consent or necessitating immediate and urgent sedation
* Patient under law protection
* Pregnant or breastfeeding women

Primary outcomes:
measure: Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission
timeFrame: 48 hours after admission
Secondary outcomes:
measure: Rate of patient's eligibility and causes of non-eligibility
timeFrame: At inclusion (day 0)
measure: Rate of study drop-out
timeFrame: through study completion, an average of 1 year
measure: Causes of study drop-outs
timeFrame: through study completion, an average of 1 year
measure: Mean delay between admission and first meditation
timeFrame: After "body scan" meditation, an average of 48 hours after admission
measure: Cause of failure of meditation administration within 48h
timeFrame: 48 hours after admission (day 0)
measure: Percentage of improvement pain, anxiety and discomfort
timeFrame: before and after "body scan" meditation, an average of 48 hours after admission
measure: Percentage of improvement at the Parkinson's disease
timeFrame: before and after "body scan" meditation, an average of 48 hours after admission
measure: Percentage of improvement at the Parkinson's disease
timeFrame: before and after "body scan" meditation, an average of 48 hours after admission
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de neurologie motricité,Hôpital Pellegrin
Study officials:
affiliation: University Hospital Bordeaux, France
name: François TISON, Prof
role: STUDY_DIRECTOR
affiliation: University Hospital Bordeaux, France
name: Caroline GAUTIER
role: PRINCIPAL_INVESTIGATOR
References: