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

Parkinson's Disease Clinical Trial

— PARAM2A  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349554
• Other study ID #: CHUBX 2016/50
• Status: Completed
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: March 5, 2019

Study information

• Verified date: March 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 5, 2019
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• body-scan meditation
15 minutes audio-guided body-scan meditation

Diagnostic Test:
• Psychological evaluation
NPI (Neuropsychiatric symptoms Inventory) - PAS (Parkinson's disease Anxiety Screening Questionnaire) - VAS measuring pain, anxiety and discomfort Before and after "body-scan" meditation

Locations

Country	Name	City	State
France	Service de neurologie motricité,Hôpital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission		48 hours after admission
Secondary	Rate of patient's eligibility and causes of non-eligibility		At inclusion (day 0)
Secondary	Rate of study drop-out		through study completion, an average of 1 year
Secondary	Causes of study drop-outs	by oral questionnaire	through study completion, an average of 1 year
Secondary	Mean delay between admission and first meditation		After "body scan" meditation, an average of 48 hours after admission
Secondary	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)	48 hours after admission (day 0)
Secondary	Percentage of improvement pain, anxiety and discomfort	by visual analog scales (VAS)	before and after "body scan" meditation, an average of 48 hours after admission
Secondary	Percentage of improvement at the Parkinson's disease	by Anxiety Screening Questionnaire (PAS)	before and after "body scan" meditation, an average of 48 hours after admission
Secondary	Percentage of improvement at the Parkinson's disease	by the Neuropsychiatric symptoms Inventory (NPI) total scores	before and after "body scan" meditation, an average of 48 hours after admission