NCT06130358

Brief Summary

In a recent report, the World Organization for Health provided some evidence that artistic and cultural activities can support the health and well-being of the population. Our previous research suggests that the effect of museum visits on well-being and stress might be tied to relaxing proprieties of contact with art objects, especially when the artwork is viewed with an introspective and self-reflexive approach. This study addresses the effect of a well-being museum intervention of six weeks on cerebral activity associated with artwork contemplation during a museum visit and assesses how it affects the psychological and cardiovascular health of older adults with and without atrial fibrillation. The well-being intervention will engage the participant in a series of 6 visits, in groups of 10, oriented on his feelings, impressions, and interpretations of artworks. This well-being museum intervention will be compared to visits typically provided in the museum, in a cross-over single-blinded design.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

November 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 8, 2023

Last Update Submit

November 16, 2023

Conditions

Keywords

Museum visitsNeurocognitionStressCardiovascular functioning

Outcome Measures

Primary Outcomes (1)

  • Change in the activity evoked within the ventrolateral prefrontal cortex during the contemplation of artwork

    Hemodynamic variations in the region of interest (concentration of oxygenated hemoglobin \[HbO2\], no units).

    Before and after the 6 weeks of interventions

Secondary Outcomes (1)

  • Change in the activity evoked within the medial prefrontal cortex during the contemplation of artwork

    Before and after the 6 weeks of interventions

Other Outcomes (14)

  • Change in Heart rate

    Before and after the 6 weeks of interventions

  • Change in arterial pressure

    Before and after the 6 weeks of interventions

  • Change in salivary cortisol concentration

    Before and after the 6 weeks of interventions

  • +11 more other outcomes

Study Arms (2)

Well-Being Museum intervention

EXPERIMENTAL

The well-being intervention comprises six weeks of weekly museum visits, performed in groups of 10 participants. The well-being approach is based on the support of a museum mediator. His role is to help visitors to develop a more personal and sensitive understanding of artworks. To do this, he encourages the expression of feelings, impressions, and interpretations of the artwork, and supports exchanges within the group of visitors. With the mediator's support, the participants should be able to adopt a more subjective approach to the artwork, favoring their engagement when contemplating it.

Other: Experimental: Well-being intervention followed by classic interventionOther: Experimental: Classic intervention followed by well-being intervention

Classic Museum intervention

ACTIVE COMPARATOR

The classic intervention comprises six weeks of weekly museum visits, performed in groups of 10 participants. The classic museum session will be performed according to what is typically provided to visitors as part of a guided visit to the museum. Each visit will be accompanied by a volunteer guide trained in art history. He will guide participants across artworks and provide information about art pieces, the artist, and the historical context. The volunteer guide will provide context and informative content about the artwork without intending to influence the discussions and the visitor's apprehension of the artwork.

Other: Experimental: Well-being intervention followed by classic interventionOther: Experimental: Classic intervention followed by well-being intervention

Interventions

2 x 6 weeks of weekly museum visits

Classic Museum interventionWell-Being Museum intervention

2 x 6 weeks of weekly museum visits

Classic Museum interventionWell-Being Museum intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men/women aged 50 and over,
  • Presenting normal or corrected vision and hearing,
  • With or without controlled Atrial fibrillation,
  • No specific expertise in visual arts (official degree or training relating to the visual arts),
  • Occasionally attended museums and exhibitions (≤ 6 times per year).

You may not qualify if:

  • Score \> 5/15 on the geriatric depression scale,
  • Score on the telephone version of the MMSE \< 19,
  • Psychiatric or neurological diagnosis,
  • Presence of major functional limitations likely to affect the individual's ability to stand and walk independently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

Location

Central Study Contacts

Emma G Dupuy, PhD

CONTACT

Louis G Bherer, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Direction of EPIC Center, Montreal heart Institute

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 14, 2023

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations