NCT06515041

Brief Summary

The effects of art on health and well-being have been the subject of increasing exploration in recent years. In 2019, the World Health Organization proposed a literature review analyzing the links between art, health (defined as a state of good functioning) and well-being. Currently, the majority of research has focused on populations presenting pathologies (somatic, neurological or psychiatric), very often in older adults. Furthermore, exposure to art (unlike the practice of an artistic activity) still remains under-investigated. However, recent publications (review and longitudinal study) suggest that attending museums would be associated with an increase in well-being, in people with or without pathology. Supported by the Blood \& Brain @ Caen Normandy Scientific Interest Group and the Museum of Fine Arts as part of the Millennium festivities of the city of Caen, the partnership between three Caen laboratories and a Parisian laboratory enabled the drawing of this innovative research which will aim to measure the effects of visiting a museum dedicated to painting on well-being in healthy adults. It will also involve identifying the cerebral, cognitive and socio-emotional processes associated with these effects, via comprehensive and ecologically adapted measurements. Through understanding the mechanisms specific to exposure to art which promote well-being, this research could have implications for:

  1. 1.Promote synergy between cultural and health policies.
  2. 2.Design museum experiences as close as possible to human functioning.
  3. 3.Open up to new perspectives such as the role of exposure to art in maintaining good health, with the possibility in the longer term of considering research on other arts, other populations, in a lifespan approach.
  4. 4.Open up to other studies of the same type involving pairs of patients and caregivers, young people and seniors, etc.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
37mo left

Started Jul 2024

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Jul 2024Jun 2029

First Submitted

Initial submission to the registry

June 26, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

July 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

July 24, 2025

Status Verified

July 1, 2024

Enrollment Period

4 years

First QC Date

June 26, 2024

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Effect of museum visit on wellbeing

    We will use a well established UCL museum wellbeing measures used to assess levels of psychological wellbeing arising from a situation.

    before and after the first visit and the second one

  • Effect of museum visit on eyes tracking

    eyes tracking glasses will be used to evaluate where the volunteers is looking on pictorials

    during each visit, 1 and 2

  • Effect of museum visit on NIRS

    NIRS, non invasive evaluation of frontal brain oxygenation allowing a follow-up of brain emotions

    during each visit, 1 and 2

  • Effet of museum visit on heart rate

    Non invasive evaluation of heart rate

    during each visit, 1 and 2

Study Arms (3)

MUSEUM VISITS with mediation: group A

OTHER

This group of volunteers will visit the museum with a mediation (I.E. description of the painting tables by a professional).

Other: brain well-being

MUSEUM VISITS without mediation: group B

OTHER

This group of volunteers will visit the museum without a mediation (I.E. description of the painting tables by a professional).

Other: brain well-being

Control group

OTHER

This group of volunteers will not visit the museum.

Other: brain well-being

Interventions

Each volunteers will be subjected to an evaluation of his well-being using a previously well established well-being scale, through a list of questions, prior, during and after the visit to the museum. All volunteers will be also equipped with a non invasive NIRS system to measure their emotions (measure of tissus oxygenenation), with a non invasive system of eye tracking glasses to measure where their eyes are looking and with a non invasive system to measure their heart rate.

Also known as: non invasive Near InfraRed Spectroscopy (NIRS), neon invasive Eye tracking glasses, non invasive Heart rate measurement, Well-being scale (list of questions)
Control groupMUSEUM VISITS with mediation: group AMUSEUM VISITS without mediation: group B

Eligibility Criteria

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

You may qualify if:

  • Adults with good mental and brain health
  • Participants (18-65 years old inclusive)
  • Good brain health: Having a MoCA score (screening tool for mild neurocognitive impairments) of 26 or above for those over 55 years old.
  • Fluent in French (native language)
  • Person who has given informed consent to participate in the study
  • Declare being able to comfortably view a painting during a museum visit without wearing glasses
  • Declare being able to listen to a conversation

You may not qualify if:

  • History or presence of a psychiatric disorder such as mood disorders, psychotic disorders, personality disorders, addictions, that have required or currently require medical follow-up and/or are in an acute phase.
  • Mobility difficulties, postural or balance disorders preventing the participant from easily moving around the museum and using stairs
  • History or presence of brain injuries such as TBI, stroke, neurological diseases
  • Chronic or long-term illnesses that could make standing uncomfortable for the participant
  • Taking medication that affects cognitive functioning
  • General anesthesia in the past six months
  • Vision impairment requiring glasses or resulting in poor detail perception at a distance of 2 to 6 meters
  • Person who has visited the permanent collection of the Caen Museum of Fine Arts at least once in the past ten years (Participants are thus either first-time visitors or people who visited the permanent collection more than ten years ago)
  • Unable to reach the museum independently
  • Hearing impairment (decibel level above 20) not using a hearing aid or whose hearing aid does not sufficiently correct the impairment
  • Speech disorder with difficulty communicating with others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

Study Officials

  • Denis Vivien, phD

    Caen Normandie University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis Vivien, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 23, 2024

Study Start

July 17, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

July 24, 2025

Record last verified: 2024-07

Locations