NCT02834598

Brief Summary

The study evaluates the benefits of a rocking movement on well-being and attention, through high-density electroencephalography recordings. The effect of the rocking movement is compared to a seated position and a lying position.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

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, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 7, 2020

Status Verified

July 1, 2016

Enrollment Period

3.3 years

First QC Date

July 13, 2016

Last Update Submit

September 4, 2020

Conditions

Rocking Movement

Outcome Measures

Primary Outcomes (1)

  • Difference of amplitude between standard and deviant sounds

    The amplitude of the mismatch negativity (corresponding to the difference between standard and deviant sounds) will be measured by electroencephalography.

    20 minutes

Study Arms (3)

Rocking movement

EXPERIMENTAL

Participant is lying in a hammock with a rocking motion. Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.

Device: high-density electroencephalography

Lying position

ACTIVE COMPARATOR

Participant is lying in a hammock with no rocking motion. Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.

Device: high-density electroencephalography

Seated position

ACTIVE COMPARATOR

Participant is sitting on a chair. Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.

Device: high-density electroencephalography

Interventions

high-density electroencephalographyDEVICE

Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.

Lying positionRocking movementSeated position

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right handed
  • Informed consent

You may not qualify if:

  • Pregnancy
  • subjects with analgesic treatment
  • subjects dependent on psychotropic substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Régis Aubry, MD, PhD

    Service douleur - soins palliatifs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

June 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

September 7, 2020

Record last verified: 2016-07