ClinicalTrials.gg
CompletedNCT03349554PARAM2AUpdated May 17, 2019

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

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

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Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 14 studies in Parkinson Disease by University Hospital, Bordeaux — 4 open to participants now, 4 under way, none of them phase 3. Parkinson Disease · University Hospital, Bordeaux.

Enrollment
5th of 12
33 · median 31
Started
2018
with 1 other
No phase
12 of 14
3 open now
Registered
6th of 14
by date

Among the 14 studies in Parkinson Disease by University Hospital, Bordeaux, this one is the 5th largest by enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2018, is one of 12 with no phase, and was the 6th registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

4 of the 14 studies in Parkinson Disease by University Hospital, Bordeaux are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 14 studies in Parkinson Disease by University Hospital, Bordeaux, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Parkinson's Disease

Keywords

  • Parkinson's disease
  • anxiety
  • meditation
  • in-patients
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • signed

Exclusion criteria

Exclusion Criteria:

  • Dementia, delusions or hallucination not permitting an or necessitating immediate and urgent sedation
  • Patient under law protection
  • Pregnant or breastfeeding women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    standardized meditation technique "body-scan"

    Other: body-scan meditation · Diagnostic Test: Psychological evaluation

Interventions

  • Otherbody-scan meditation

    15 minutes audio-guided body-scan meditation

  • Diagnostic testPsychological evaluation

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

06

What researchers measure

Primary outcomes

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

    Time frame: 48 hours after admission

Secondary outcomes

  1. Rate of patient's eligibility and causes of non-eligibility

    Time frame: At inclusion (day 0)

  2. Rate of study drop-out

    Time frame: through study completion, an average of 1 year

  3. Causes of study drop-outs

    by oral questionnaire

    Time frame: through study completion, an average of 1 year

  4. Mean delay between admission and first meditation

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

  5. 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)

  6. 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

  7. 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

  8. 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

07

Study locations

1 site
  • Service de neurologie motricité,Hôpital Pellegrin
    Bordeaux, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Mar 2019, 11 months.

Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 11 months is below that.

Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2017
First posted
Nov 21, 2017
StartActual
Mar 23, 2018
Primary completionActual
Mar 5, 2019
CompletionActual
Mar 5, 2019
Last update
May 17, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03349554
Responsible party
Sponsor
First posted
Nov 21, 2017
Start date
Mar 23, 2018
Primary completion
Mar 5, 2019
Completion
Mar 5, 2019
Last update
May 17, 2019

Study contacts

François TISON, Prof
study director · University Hospital Bordeaux, France
Caroline GAUTIER
principal investigator · University Hospital Bordeaux, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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