- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05310747
Can Exposure to Inclusive Virtual Art Decrease Pain and Social Disconnection Among Individuals Living With Chronic Pain?
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- University of California, Davis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Artwork present + social connection high
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
|
A virtual museum exhibit with a curated selection of artworks
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.
|
|
Experimental: Artwork present + social connection low
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
|
A virtual museum exhibit with a curated selection of artworks
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.
|
|
Experimental: Artwork absent + social connection high
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
|
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.
The same virtual museum exhibit space as the 'Artwork present' condition but with all of the artworks removed from the walls
|
|
Active Comparator: Artwork absent + social connection low
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
|
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.
The same virtual museum exhibit space as the 'Artwork present' condition but with all of the artworks removed from the walls
|
|
No Intervention: Hanging control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social disconnection
Time Frame: Post-intervention (immediately)/Day 1
|
Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60
|
Post-intervention (immediately)/Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain unpleasantness
Time Frame: Post-intervention (immediately)/Day 1
|
Numerical rating scale (NRS) score of 0 "not unpleasant" - 10 "Most unpleasant sensation imaginable ("intolerable")"
|
Post-intervention (immediately)/Day 1
|
|
Pain intensity
Time Frame: Post-intervention (immediately)/Day 1
|
Numerical rating scale (NRS) score of 0 "no pain" - 10 "worst pain imaginable"
|
Post-intervention (immediately)/Day 1
|
|
Change in pain during intervention
Time Frame: Post-intervention (immediately)/Day 1
|
Did you experience any pain relief during the museum experience?
1=Yes/0=No
|
Post-intervention (immediately)/Day 1
|
|
Percent change in pain during intervention
Time Frame: Post-intervention (immediately)/Day 1
|
If "Yes", what percent pain relief did you receive?
0%-100%
|
Post-intervention (immediately)/Day 1
|
|
Perceptions of the artwork related to the positivity of the social world
Time Frame: Post-intervention (immediately)/Day 1
|
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
|
|
Perceptions of the artwork related to connection to the social world
Time Frame: Post-intervention (immediately)/Day 1
|
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
|
|
Perceptions of the artwork related to inclusion in the social world
Time Frame: Post-intervention (immediately)/Day 1
|
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
|
|
Perceptions of the artwork related to positivity of social relationships
Time Frame: Post-intervention (immediately)/Day 1
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Museum visit data - User Movement
Time Frame: During intervention
|
Each user's avatar movement will be calculated in an x, y, z axis within the structure of the virtual museum.
|
During intervention
|
|
Museum Visit Data - Object Interaction
Time Frame: During intervention
|
Number of clicks on virtual museum artwork.
Clicking gives users access to additional information about each piece of art.
|
During intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1811205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
University Rovira i VirgiliMinisterio de Ciencia e Innovación, SpainNot yet recruitingChronic Post-operative Pain | Chronic Postsurgical Pain | Chronic Post-surgical Pain | Chronic Postoperative PainSpain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Washington D.C. Veterans Affairs Medical CenterRecruitingChronic Back Pain | Chronic Pain (back / Neck)United States
-
Bjorn AngKarolinska Institutet; The Swedish Research Council; Göteborg University; Forte; Dalarna...Not yet recruitingPain Management | Pain, Chronic | Chronic Pain, WidespreadSweden
-
The University of Texas Health Science Center,...RecruitingJoint Pain | Chronic Knee Pain | Chronic Pain (Back / Neck) | Chronic Pain ManagementUnited States
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of FaisalabadNot yet recruiting
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Massachusetts General HospitalCompletedChronic Low Back Pain | Chronic Neck PainUnited States
-
Universidade do Vale do ParaíbaCAPES Foundation - Ministry of Education, Brazil.Enrolling by invitationChronic Low Back Pain | Chronic Shoulder Pain | Chronic Knee PainBrazil
Clinical Trials on Artwork present
-
The Hong Kong Polytechnic UniversityHospital Authority, Hong KongCompletedMental Health IssueHong Kong
-
Milton S. Hershey Medical CenterCompleted
-
University of Alabama at BirminghamCompletedElbow InjuryUnited States
-
University of Alabama at BirminghamCompleted
-
Hartford HospitalCompletedUrinary Incontinence | Surgery | Knowledge, Attitudes, Practice | Prolapse, VaginalUnited States
-
Superior UniversityActive, not recruitingComparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in AKAPPhantom Limb PainPakistan
-
Northwestern UniversityCompletedPain | Anxiety | Health Knowledge, Attitudes, PracticeUnited States
-
Hospital Departamental de VillavicencioCompletedTraumatic Brain InjuriesColombia
-
Selkin Yılmaz MulukCompleted
-
US Department of Veterans AffairsCompletedStress Disorders, Post-TraumaticUnited States