NCT02528578

Brief Summary

The objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception. It is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating. In this study, the volunteer will receive painful thermal stimuli in empathetic context (l, empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or minimize the suffering of the voluntary and the other or the contrary, the subject will receive empathy. The first part of the project is to verify that the pain is influenced by the empathetic context. The second part will be conducted functional MRI, which should isolate the brain regions affected by other people's empathy for pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

June 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

August 17, 2015

Last Update Submit

September 25, 2017

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Intensity of the perceived pain assessed by the volunteer by a analog scale (VAS) at each thermal stimulation.

    Day 0

Secondary Outcomes (1)

  • blood-oxygen-level dependent (MRI)

    Day 0

Study Arms (1)

healthy volunteers

EXPERIMENTAL
Device: thermal stimulation delivered by a thermode.Other: functional MRI

Interventions

thermal stimulation delivered by a thermode.DEVICE

Empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation

healthy volunteers
functional MRIOTHER

MRI realised with thermal stimulations and empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation

healthy volunteers

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Right handed

You may not qualify if:

  • Pregnant or lactating women,
  • Against-indications to MRI
  • Drug intake of less than 12 hours,
  • Neurological history or deficits, psychiatric, auditory or visual.
  • Decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospices Civils de LYON

Lyon, 69500, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

Study Officials

  • Roland PEYRON, MD

    CHU de SAINT-ETIENNE

    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

August 17, 2015

First Posted

August 19, 2015

Study Start

June 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 26, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)