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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05310747
Other study ID # IRB# 1811205-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2022
Est. completion date January 6, 2023

Study information

Verified date April 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study is an experimental intervention to test for the effects of exposure to art by means of a virtual museum visit. It examines the fundamental question of whether exposure to virtual art can alleviate pain. Google Arts & Culture has digitized the collections of over 2,000 museums, art galleries, and other cultural institutions. The platform is free and allows 'visitors' to explore art from around the world. For this study, the PIs have chosen artwork from this collection and created a virtual museum gallery such that research participants will visit the museum with or without art (i.e., we will remove all art from the virtual galleries). In addition, we hypothesize that individuals primed to experience social connection prior to art exposure will experience lower perceived social disconnection and pain than those who are not primed.


Description:

Research Design: 2 (virtual artwork exposure: present, absent) x 2 (prime: social connection prime: high, low) factorial experiment with a hanging control group (4 cells plus 1 control group, for a total of 5 cells) and 2 repeated measures. A priori power analysis using G*Power showed that the required sample size for a 5-group repeated measures experiment with 2 measurement times with 1-B error probability = .80 that expected small effect with a size of d = .10 and a significance level of p = .05 was a total of 305 participants (61 participants per cell). Eligible individuals will be offered informed consent documentation via the StudyPages platform and then will be randomized to their study group: 1. Artwork present + Social connection prime high 2. Artwork present + Social connection prime low 3. Artwork absent + Social connection prime high 4. Artwork absent + Social connection prime low 5. Hanging control group - no exposure to any independent variables (i.e. artwork: present or absent; social connection prime: high or low) Participants will fill out pre-intervention scales (pain intensity and unpleasantness; perceived social disconnection) prior to their virtual museum experience. Participants will then visit a virtual art museum gallery for 10 minutes or receive no exposure if they are in the hanging control group. In the artwork present condition, the virtual museum will feature paintings as part of an exhibition. In the artwork absent condition, paintings will be removed and thus the virtual museum will be empty. In the high social connection prime condition participants will be assigned to write an essay about a person and situation that made them feel valued, seen, and heard. In the low social connection prime condition participants will be assigned to write about a person and situation that made them feel ignored and not very valued. After 10 minutes within their condition participants will complete a post-intervention survey. In addition, written responses to the social connection primes and museum visit data (e.g., user movement, object interaction, and perceptions about artwork in the museum) will be collected and analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 311
Est. completion date January 6, 2023
Est. primary completion date January 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - read and write in English language - chronic moderate to severe pain (= 6 months in duration; = 4 in response to the question, "on average this week my pain intensity has been?" on a 0-10 NRS) - lonely (= 4 on the 3-item Loneliness Scale) - access to an electronic device with internet connection in order to participate in the study Exclusion Criteria: - dementia - adults unable to consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Artwork present
A virtual museum exhibit with a curated selection of artworks
Artwork absent
The same virtual museum exhibit space as the 'Artwork present' condition but with all of the artworks removed from the walls
Social connection high
Participants will identify a person from their life that makes them feel socially connected and then write (1) about that person and (2) an experience they had with that person that made them feel socially connected.
Social connection low
Participants will identify a person from their life that makes them feel socially disconnected and then write (1) about that person and (2) an experience they had with that person that made them feel socially disconnected.

Locations

Country Name City State
United States University of California, Davis Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Museum visit data - User Movement Each user's avatar movement will be calculated in an x, y, z axis within the structure of the virtual museum. During intervention
Other Museum Visit Data - Object Interaction Number of clicks on virtual museum artwork. Clicking gives users access to additional information about each piece of art. During intervention
Primary Social disconnection Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60 Post-intervention (immediately)/Day 1
Secondary Pain unpleasantness Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")" Post-intervention (immediately)/Day 1
Secondary Pain intensity Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable" Post-intervention (immediately)/Day 1
Secondary Change in pain during intervention Did you experience any pain relief during the museum experience? 1=Yes/0=No Post-intervention (immediately)/Day 1
Secondary Percent change in pain during intervention If "Yes", what percent pain relief did you receive? 0%-100% Post-intervention (immediately)/Day 1
Secondary Perceptions of the artwork related to the positivity of the social world The artwork in the museum made me feel (7-point likert scale anchored by "Negative about the social world" and "Positive about the social world") Post-intervention (immediately)/Day 1
Secondary Perceptions of the artwork related to connection to the social world The artwork in the museum made me feel (7-point likert scale anchored by "Disconnected to the social world" and "Connected to the social world") Post-intervention (immediately)/Day 1
Secondary Perceptions of the artwork related to inclusion in the social world The artwork in the museum made me feel (7-point likert scale anchored by "Excluded from the social world" and "Included in the social world") Post-intervention (immediately)/Day 1
Secondary Perceptions of the artwork related to positivity of social relationships The artwork in the museum made me feel (7-point likert scale anchored by "Negative about my social relationships" and "Positive about my social relationships" Post-intervention (immediately)/Day 1
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