A Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: body-scan meditation; Diagnostic Test: Psychological evaluation

• Registration Number: NCT03349554
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-21
• Status Verified: 2018-03
• Study Start: 2018-03-23
• Primary Completion: 2019-03-05
• Study Completion: 2019-03-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
standardized meditation technique "body-scan"	body-scan meditation	-
standardized meditation technique "body-scan"	Psychological evaluation	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission	48 hours after admission

Secondary Outcome Measures

Name	Time	Method
Rate of patient's eligibility and causes of non-eligibility	At inclusion (day 0)
Causes of study drop-outs	through study completion, an average of 1 year	by oral questionnaire
Cause of failure of meditation administration within 48h	48 hours after admission (day 0)	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)
Rate of study drop-out	through study completion, an average of 1 year
Percentage of improvement pain, anxiety and discomfort	before and after "body scan" meditation, an average of 48 hours after admission	by visual analog scales (VAS)
Mean delay between admission and first meditation	After "body scan" meditation, an average of 48 hours after admission
Percentage of improvement at the Parkinson's disease	before and after "body scan" meditation, an average of 48 hours after admission	by the Neuropsychiatric symptoms Inventory (NPI) total scores

Trial Locations

Locations (1)

Service de neurologie motricité,Hôpital Pellegrin; 🇫🇷 Bordeaux, France