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Can Exposure to Inclusive Virtual Art Decrease Pain and Social Disconnection Among Individuals Living With Chronic Pain?

Primary Purpose

Chronic Pain, Social Disconnection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artwork present
Artwork absent
Social connection high
Social connection low
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Pain, Social Disconnection, Museum, Virtual museum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

Artwork present + social connection high

Artwork present + social connection low

Artwork absent + social connection high

Artwork absent + social connection low

Hanging control group

Arm Description

Individuals participate in an exercise to prime a feeling of high social connection and then explore a virtual museum exhibit with artwork for 10 minutes

Individuals participate in an exercise to prime a feeling of low social connection and then explore a virtual museum exhibit with artwork for 10 minutes

Individuals participate in an exercise to prime a feeling of high social connection and then explore a virtual museum exhibit with no artwork for 10 minutes

Individuals participate in an exercise to prime a feeling of low social connection and then explore a virtual museum exhibit with no artwork for 10 minutes

Individuals will receive no exposure to any independent variables (i.e. artwork: present or absent; social connection prime: high or low) for 10 minutes before completing their final survey.

Outcomes

Primary Outcome Measures

Social disconnection
Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60

Secondary Outcome Measures

Pain unpleasantness
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
Pain intensity
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Change in pain during intervention
Did you experience any pain relief during the museum experience? 1=Yes/0=No
Percent change in pain during intervention
If "Yes", what percent pain relief did you receive? 0%-100%
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")
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")
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")
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"

Full Information

First Posted
December 16, 2021
Last Updated
April 10, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT05310747
Brief Title
Can Exposure to Inclusive Virtual Art Decrease Pain and Social Disconnection Among Individuals Living With Chronic Pain?
Official Title
Can Exposure to Inclusive Virtual Art Decrease Pain and Social Disconnection Among Individuals Living With Chronic Pain?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
January 6, 2023 (Actual)
Study Completion Date
January 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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: Artwork present + Social connection prime high Artwork present + Social connection prime low Artwork absent + Social connection prime high Artwork absent + Social connection prime low 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Social Disconnection
Keywords
Pain, Social Disconnection, Museum, Virtual museum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Eligible individuals will be randomized to one of 4 groups: Artwork present + Social connection prime high Artwork present + Social connection prime low Artwork absent + Social connection prime high Artwork absent + Social connection prime low Hanging control group - no exposure to any independent variables (i.e. artwork: present or absent; social connection prime: high or low)
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artwork present + social connection high
Arm Type
Experimental
Arm Description
Individuals participate in an exercise to prime a feeling of high social connection and then explore a virtual museum exhibit with artwork for 10 minutes
Arm Title
Artwork present + social connection low
Arm Type
Experimental
Arm Description
Individuals participate in an exercise to prime a feeling of low social connection and then explore a virtual museum exhibit with artwork for 10 minutes
Arm Title
Artwork absent + social connection high
Arm Type
Experimental
Arm Description
Individuals participate in an exercise to prime a feeling of high social connection and then explore a virtual museum exhibit with no artwork for 10 minutes
Arm Title
Artwork absent + social connection low
Arm Type
Active Comparator
Arm Description
Individuals participate in an exercise to prime a feeling of low social connection and then explore a virtual museum exhibit with no artwork for 10 minutes
Arm Title
Hanging control group
Arm Type
No Intervention
Arm Description
Individuals will receive no exposure to any independent variables (i.e. artwork: present or absent; social connection prime: high or low) for 10 minutes before completing their final survey.
Intervention Type
Behavioral
Intervention Name(s)
Artwork present
Intervention Description
A virtual museum exhibit with a curated selection of artworks
Intervention Type
Behavioral
Intervention Name(s)
Artwork absent
Intervention Description
The same virtual museum exhibit space as the 'Artwork present' condition but with all of the artworks removed from the walls
Intervention Type
Behavioral
Intervention Name(s)
Social connection high
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social connection low
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social disconnection
Description
Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60
Time Frame
Post-intervention (immediately)/Day 1
Secondary Outcome Measure Information:
Title
Pain unpleasantness
Description
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
Time Frame
Post-intervention (immediately)/Day 1
Title
Pain intensity
Description
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
Time Frame
Post-intervention (immediately)/Day 1
Title
Change in pain during intervention
Description
Did you experience any pain relief during the museum experience? 1=Yes/0=No
Time Frame
Post-intervention (immediately)/Day 1
Title
Percent change in pain during intervention
Description
If "Yes", what percent pain relief did you receive? 0%-100%
Time Frame
Post-intervention (immediately)/Day 1
Title
Perceptions of the artwork related to the positivity of the social world
Description
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")
Time Frame
Post-intervention (immediately)/Day 1
Title
Perceptions of the artwork related to connection to the social world
Description
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")
Time Frame
Post-intervention (immediately)/Day 1
Title
Perceptions of the artwork related to inclusion in the social world
Description
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")
Time Frame
Post-intervention (immediately)/Day 1
Title
Perceptions of the artwork related to positivity of social relationships
Description
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"
Time Frame
Post-intervention (immediately)/Day 1
Other Pre-specified Outcome Measures:
Title
Museum visit data - User Movement
Description
Each user's avatar movement will be calculated in an x, y, z axis within the structure of the virtual museum.
Time Frame
During intervention
Title
Museum Visit Data - Object Interaction
Description
Number of clicks on virtual museum artwork. Clicking gives users access to additional information about each piece of art.
Time Frame
During intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Can Exposure to Inclusive Virtual Art Decrease Pain and Social Disconnection Among Individuals Living With Chronic Pain?

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