NCT03349554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 23, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2019

Completed
Last Updated

May 17, 2019

Status Verified

March 1, 2018

Enrollment Period

12 months

First QC Date

October 26, 2017

Last Update Submit

May 16, 2019

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseanxietymeditationin-patients

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients that received a first experience of standardized "body scan" meditation within 48H after admission

    48 hours after admission

Secondary Outcomes (8)

  • Rate of patient's eligibility and causes of non-eligibility

    At inclusion (day 0)

  • Rate of study drop-out

    through study completion, an average of 1 year

  • Causes of study drop-outs

    through study completion, an average of 1 year

  • Mean delay between admission and first meditation

    After "body scan" meditation, an average of 48 hours after admission

  • Cause of failure of meditation administration within 48h

    48 hours after admission (day 0)

  • +3 more secondary outcomes

Study Arms (1)

standardized meditation technique "body-scan"

EXPERIMENTAL
Other: body-scan meditationDiagnostic Test: Psychological evaluation

Interventions

body-scan meditationOTHER

15 minutes audio-guided body-scan meditation

standardized meditation technique "body-scan"
Psychological evaluationDIAGNOSTIC_TEST

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

standardized meditation technique "body-scan"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de neurologie motricité,Hôpital Pellegrin

Bordeaux, France

Location

MeSH Terms

Conditions

Parkinson DiseaseAnxiety Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesMental Disorders

Study Officials

  • François TISON, Prof

    University Hospital Bordeaux, France

    STUDY DIRECTOR

  • Caroline GAUTIER

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 21, 2017

Study Start

March 23, 2018

Primary Completion

March 5, 2019

Study Completion

March 5, 2019

Last Updated

May 17, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)