Benefits of participating in art museum activities on health and wellbeing
| ISRCTN | ISRCTN33089696 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33089696 |
| Secondary identifying numbers | HEALTH IN ARTS-01 |
- Submission date
- 29/10/2025
- Registration date
- 30/10/2025
- Last edited
- 30/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
There is increasing interest in how participation in art events, including museum and exhibition visits, contributes to individual and community wellbeing. Active involvement in creative and cultural activities offers a wide range of benefits, such as promoting wellbeing, quality of life and health. Engagement in the arts is a novel approach to improve the health of diverse adult subjects.
The main aim of this study is to investigate the psychological and physiological patterns evoked during a semi-free exploration of an art museum exhibition as compared to a control neutral experience of daily life, according to advanced techniques evaluating psychological wellbeing, anxiety, neurophysiological changes, emotional arousal, physiological changes in heart rate and blood pressure, salivary stress hormones and biomarkers.
Who can participate?
Healthy adults aged 18-30 years
What does the study involve?
Participants will be randomly allocated either to the experimental experience (which will consist of a 90-minute semi-free visit to the exhibition floors of the FLR Museum) or to the control experience (which will consist of 90 minutes of a "neutral" activity in the non-exposition spaces of the FLR Museum). For an individual participant the study in the unique experimental day will last approximately 3 hours, of which 90 minutes will be devoted to the experience.
What are the possible benefits and risks of participating?
Possible benefits for the participants in the museum experience include positive effects on the state of mind and general well-being. There are no risks associated with study procedures.
Where is the study run from?
Fondazione Luigi Rovati (FLR) Art Museum, Milan, Italy.
When is the study starting and how long it is expected to run for?
April 2024 to June 2026
Who is funding the study?
The Fondazione Luigi Rovati (FLR), the study sponsor, is a not-for-profit organization engaged in several cultural activities and initiatives
Who is the main contact?
Dr Lucio Rovati, lucio.rovati@fondazioneluigirovati.org
Contact information
Public, Scientific, Principal investigator
Corso Venezia 52
Milan
20121
Italy
| Phone | +39 (0)399066104 |
|---|---|
| lucio.rovati@fondazioneluigirovati.org |
Study information
| Study design | Single-centre prospective randomized open-label parallel-group controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Clinical evaluation of the benefits of engaging in arts on health and wellbeing of young adults participating in museum activities |
| Study acronym | HIA-01 |
| Study objectives | There is increasing interest in how participation in art events, including museum and exhibition visits, contributes to individual and community wellbeing. The precise influence of art-based interventions on wellbeing and related psychological and physiological parameters is difficult to quantify, mainly because of the lack of randomized controlled clinical studies. The main aim of the present study is therefore to comparatively and quantitatively investigate the psychological and physiological patterns evoked during a semi-free exploration of an art museum exhibition as compared to a control neutral experience of daily life. The study venue will be the Fondazione Luigi Rovati (FLR) Museum in Milan, Italy. |
| Ethics approval(s) |
Approved 28/03/2024, IEC of the University of Milano-Bicocca (Piazza dell'Ateneo Nuovo, 1, Milano, 20126, Italy; +39 (0)2 6448 6581; comitatoetico@unimib.it), ref: 0149791-28/03/2024 UOR 003406 |
| Health condition(s) or problem(s) studied | Promoting wellbeing, quality of life and health |
| Intervention | Randomisation by a computer-generated list to: Experimental: a museum visit, a semi-free visit to the FLR Museum exhibition halls Placebo comparator: a “neutral” experience in the FLR Museum non-exhibition spaces |
| Intervention type | Other |
| Primary outcome measure | Change in the mean UCL Museum Wellbeing Measure, specifically the Positive Wellbeing Umbrella Generic, before and after the experience |
| Secondary outcome measures | 1. Anxiety state evaluated by the STAI Y-1 before and after the experience 2. Neurophysiological parameters measured by EEG throughout the experience 3. Emotional activation measured by Galvanic Skin Response (GSR) throughout the experience 4. Blood pressure and heart rate measured before and after the experience by the OMRON EVOLV Automatic Upper Arm Blood Pressure Monitor 5. Heart rate variability (HRV) measured throughout the experience by the Shimmer3 GSR+ wrist device capturing an Optical Pulse/PPG (Photoplethysmogram) signal 6. Salivary levels of neuroendocrine stress hormones and biomarkers of catecholamines release measured before and after the experience. Saliva was collected using a SALIVETTE® device (SARSTEDT, Numbrecht, Netherlands) and analysed by commercially available kits. |
| Overall study start date | 28/03/2024 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | All |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Age 18-30 years, all genders and self-identified as healthy 2. Fluent in Italian 3. Able to understand the study aim and to adhere to the study protocol procedures, and having signed an Informed Consent Form prior to the initiation of the study |
| Key exclusion criteria | Have already visited the FLR Museum venue |
| Date of first enrolment | 30/04/2024 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Italy
Study participating centre
Milan
20121
Italy
Sponsor information
Charity
Corso Venezia 52
Milan
20121
Italy
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
29/10/2025: Study's existence confirmed by the IEC of the University of Milano-Bicocca.
