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Effects of Social Presence and Perception in Virtual Reality on Pain (SPP)

Primary Purpose

Chronic Pain, Widespread

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Near Non-Social
Near Social
Far Non-Social
Far Social
Sponsored by
Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain, Widespread

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Consenting adult

Exclusion Criteria:

  1. History of cardiovascular disorder
  2. History of fainting or seizures
  3. Open cut or sore on hand to be thermally tested
  4. Burn or sunburn on hand to be thermally tested.
  5. Pregnancy
  6. Prone to motion sickness, or have balance or dizziness conditions
  7. Recent concussion
  8. Seizure disorders
  9. History of fainting or seizures
  10. Visual impairment

Sites / Locations

  • Cornell Virtual Embodiment Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Time 1

Time 2

Time 3

Time 4

Arm Description

Participant will be randomly assigned to one of the four interventions; either Near Non-Social, Near Social, Far Non-Social, or Far Social

Participant will be randomly assigned to one of the remaining three interventions; either Near Non-Social, Near Social, Far Non-Social, or Far Social

Participant will be randomly assigned to one of the remaining two interventions; either Near Non-Social, Near Social, Far Non-Social, or Far Social

Participant will complete the remaining intervention; either Near Non-Social, Near Social, Far Non-Social, or Far Social

Outcomes

Primary Outcome Measures

Pain threshold in degrees tolerated at end of trial
Change in temperature from the beginning to the end of each trial (when the heat ramp begins, and when participants remove their hands) will be noted in milliseconds.

Secondary Outcome Measures

Self-reported social presence
Questionnaire of self-reported feelings of social presence with the confederate
Self-reported environmental presence
Questionnaire of self-reported feelings of presence in the virtual environment

Full Information

First Posted
May 9, 2017
Last Updated
January 24, 2022
Sponsor
Cornell University
Collaborators
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT03157362
Brief Title
Effects of Social Presence and Perception in Virtual Reality on Pain
Acronym
SPP
Official Title
Effects of Social Presence and Perception in Virtual Reality on Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
November 8, 2018 (Actual)
Study Completion Date
November 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
Weill Medical College of Cornell University

4. Oversight

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

5. Study Description

Brief Summary
This experiment aims to examine the effects of transportation via social presence in "near" and "far" virtual environments, on pain threshold in two groups: 1. healthy volunteers in an induced pain task, and 2. older adults suffering from pain. In the first, pilot group, a within-subjects study, participants will complete a series of induced-pain heat ramps in virtual environments that are "near" or "far"-in other words, they will either duplicate their actual physical environment, or represent another location. A second factor in this experiment will be mediated social presence, in which participants interact with confederates as avatars in either condition. The hypotheses follow: H1: Participants who feel present in a remote location will have a higher pain tolerance than those in a near location. H2: Participants who feel socially present with a confederate will have a higher pain tolerance than those who are alone in a virtual environment. H3: There will be an interaction between social presence and virtual environment such that participants who feel socially present in a remote location will have the highest pain tolerance overall. Building on these results,the next step will be a long-term study on older adult pain patients. In this step, the most successful condition in the first study to lightweight, portable headsets that can be used outside of the lab environment. This intervention will be tested on older adult patients who are suffering from chronic pain.
Detailed Description
BACKGROUND AND SIGNIFICANCE: Virtual reality (VR) has been used to treat pain for over 15 years but the mechanism of pain relief remains to be fully explored. Virtual reality is a particularly high-presence medium, in that people using VR tend to react to mediated content as if it were salient to their physical selves. Like this sense of presence, pain is a subjective phenomenon- it exists only as perceived by an individual. The vivid and interactive nature of VR creates a sense of presence in the virtual world, or in virtual bodies, by plausibly replacing sensory information from the real world with sensory information that creates a virtual environment and/or body. Previous work has found that presence in virtual environments reduces pain. Presence in virtual reality, and in media in general, is frequently referred to metaphorically as transportation. For example, people say about someone who's reading a book, "She's in another world" or complain, "he's not present with me now, he's distracted by your phone." When a person in pain subjectively feels that he or she is not present in the real-world location of the painful stimulus, his or her sense of actual or potential damage may be less, and therefore his or her pain tolerance may be greater. One component of virtual worlds that may affect pain perception is thus their ability to "transport" the viewer to locations other than the hospital, their home, or other places where they are experiencing pain. Previous pilot work on presence in remote environments in virtual reality indicated that presence in a "far" as opposed to a "near" virtual environment increased pain tolerance in an induced pain task. While these results point towards the idea that transportation through presence in virtual reality can increase pain tolerance or increase pain threshold, this result requires more support to justify deploying to a patient population. However, virtual worlds also allow for social interaction, which has the potential to strongly affect both pain and the sensation of presence in an environment. While social support has been linked to pain reduction, in a recent study, participants who texted with a stranger while undergoing surgery were less likely to require analgesia than those who texted with companions or played a distracting game on their phone. While the authors propose that the context of the chat may have affected participants' pain levels, another additive possibility is that these patients were experiencing social presence with the strangers, who were conversing from a location outside the hospital, and were thus feeling less present in the hospital environment. This might explain why participants received greater benefit from these text conversations than from conversations with loved ones, who were conversing from the hospital environment where their pain occurred. This aligns with other research that shows that participants in a text conversation estimate the physical distance to their conversational partner to be greater if they feel less socially present with that conversational partner. The following experiment will compare the effects of social presence and transportation in immersive virtual reality environments, and serve as a baseline to design more widely accessible interventions. METHODS AND RESEARCH STRATEGY: A power analysis on a between-subjects pilot study on normal participants comparing near and far virtual environments suggests 48.5 participants for a power of .8. This study is a within-subjects design which should require less power. However, to account for participant attrition 75 participants will be invited to the first pilot study. In order to rapidly collect this number of patients with minimal risk, data collection will begin with a student sample of convenience. The most successful stimuli will then be modified to trial in older adults in a long-term study looking at VR for patients already suffering from pain. In the first sample, participants will visit the lab once to complete an experiment lasting less than one hour. Each participant will experience four conditions crossing "near" and "far" virtual environments, and social presence or no social presence. (In this experiment, social presence will be operationalized as a conversation with a confederate represented by an avatar). Participants will be stably seated, and observed by a research assistant, as they experience four environments: 1. A virtual environment that reproduces the room in which they are seated. 2. A virtual environment that reproduces the room in which they are seated, in which participants will view and converse with a confederate represented by an avatar. 3. Another location. 4. Another location, in which participants will view and converse with a confederate represented by an avatar. Confederates will follow a script to keep the conversations of similar length and content. During each condition, participants will complete an induced pain task using a Medoc TSA-2001/Model Q-Sense thermode. (For more detailed discussion of this device, and of the stimulus justification, please see the Human Subjects Issues section of the Data Safety Monitoring Plan). Prior to experiencing the four experimental conditions, participants will complete a "practice" induced pain task while viewing a duplication of the virtual environment. This will allow them to orient themselves to both the virtual environment and the pain task, since based on the pilot experiment, order effects are predicted to be most notable for the first pain task administered. In this and all subsequent induced pain tasks, participants will place their non-dominant hand on the thermode and will be instructed to remove their hand as soon as they feel the temperature has become "painful". The beginning and end of each trial (when the heat ramp begins, and when participants remove their hands) will be noted, and that time duration, and thus the degree of temperature to which it corresponds, will serve as the measure of pain threshold for that trial. In addition to this outcome measure, after each pain trial participants will also fill out a brief self-report survey. These measures will include their self-reported feelings of presence in the virtual environment, and social presence with the confederate. The survey will also include manipulation checks to establish whether participants believed the confederate to be a real person, and whether they believed that the confederate was in the location described in each condition. All subsequent conditions will be presented in a randomized order to control for order effects, and conducted as follows. The time to complete these surveys will be approximately 7-10 minutes, which will also allow participants time between each trial to reorient themselves to the real environment, and for any lingering effects of heat on their hands to dissipate. Finally, participants' movements will be tracked in order to provide an additional indication of how participants engaged with the virtual environment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Widespread

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant will experience four conditions, in a random order, crossing "near" and "far" virtual environments, and social presence or no social presence.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will not be informed of what condition they are assigned to. The research assistants who code the data will also not be informed of condition.
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time 1
Arm Type
Active Comparator
Arm Description
Participant will be randomly assigned to one of the four interventions; either Near Non-Social, Near Social, Far Non-Social, or Far Social
Arm Title
Time 2
Arm Type
Active Comparator
Arm Description
Participant will be randomly assigned to one of the remaining three interventions; either Near Non-Social, Near Social, Far Non-Social, or Far Social
Arm Title
Time 3
Arm Type
Active Comparator
Arm Description
Participant will be randomly assigned to one of the remaining two interventions; either Near Non-Social, Near Social, Far Non-Social, or Far Social
Arm Title
Time 4
Arm Type
Active Comparator
Arm Description
Participant will complete the remaining intervention; either Near Non-Social, Near Social, Far Non-Social, or Far Social
Intervention Type
Other
Intervention Name(s)
Near Non-Social
Intervention Description
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience a virtual environment that reproduces the room in which they are seated.
Intervention Type
Other
Intervention Name(s)
Near Social
Intervention Description
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience a virtual environment that reproduces the room in which they are seated, and converse with a confederate represented by an avatar.
Intervention Type
Other
Intervention Name(s)
Far Non-Social
Intervention Description
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience a virtual environment that reproduces a different room.
Intervention Type
Other
Intervention Name(s)
Far Social
Intervention Description
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience a virtual environment that reproduces another room, and converse with a confederate represented by an avatar.
Primary Outcome Measure Information:
Title
Pain threshold in degrees tolerated at end of trial
Description
Change in temperature from the beginning to the end of each trial (when the heat ramp begins, and when participants remove their hands) will be noted in milliseconds.
Time Frame
The beginning and end of each trial < 90 seconds
Secondary Outcome Measure Information:
Title
Self-reported social presence
Description
Questionnaire of self-reported feelings of social presence with the confederate
Time Frame
~15 minutes at the end of each trial
Title
Self-reported environmental presence
Description
Questionnaire of self-reported feelings of presence in the virtual environment
Time Frame
~15 minutes at the end of each trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Consenting adult Exclusion Criteria: History of cardiovascular disorder History of fainting or seizures Open cut or sore on hand to be thermally tested Burn or sunburn on hand to be thermally tested. Pregnancy Prone to motion sickness, or have balance or dizziness conditions Recent concussion Seizure disorders History of fainting or seizures Visual impairment
Facility Information:
Facility Name
Cornell Virtual Embodiment Lab
City
Ithaca
State/Province
New York
ZIP/Postal Code
14853
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10692634
Citation
Hoffman HG, Doctor JN, Patterson DR, Carrougher GJ, Furness TA 3rd. Virtual reality as an adjunctive pain control during burn wound care in adolescent patients. Pain. 2000 Mar;85(1-2):305-9. doi: 10.1016/s0304-3959(99)00275-4.
Results Reference
background
Citation
F. P. Brooks Jr, 1990. Virtual reality at work. Human Machine Interfaces for Teleoperators and Virtual Environments, 67.
Results Reference
background
PubMed Identifier
12909433
Citation
Moseley GL. A pain neuromatrix approach to patients with chronic pain. Man Ther. 2003 Aug;8(3):130-40. doi: 10.1016/s1356-689x(03)00051-1.
Results Reference
background
PubMed Identifier
15803164
Citation
Sanchez-Vives MV, Slater M. From presence to consciousness through virtual reality. Nat Rev Neurosci. 2005 Apr;6(4):332-9. doi: 10.1038/nrn1651.
Results Reference
background
PubMed Identifier
15327820
Citation
Hoffman HG, Sharar SR, Coda B, Everett JJ, Ciol M, Richards T, Patterson DR. Manipulating presence influences the magnitude of virtual reality analgesia. Pain. 2004 Sep;111(1-2):162-8. doi: 10.1016/j.pain.2004.06.013.
Results Reference
background
PubMed Identifier
23365736
Citation
de Tommaso M, Ricci K, Laneve L, Savino N, Antonaci V, Livrea P. Virtual visual effect of hospital waiting room on pain modulation in healthy subjects and patients with chronic migraine. Pain Res Treat. 2013;2013:515730. doi: 10.1155/2013/515730. Epub 2013 Jan 10.
Results Reference
background
PubMed Identifier
12651995
Citation
Brown JL, Sheffield D, Leary MR, Robinson ME. Social support and experimental pain. Psychosom Med. 2003 Mar-Apr;65(2):276-83. doi: 10.1097/01.psy.0000030388.62434.46.
Results Reference
background
PubMed Identifier
25529995
Citation
Guillory JE, Hancock JT, Woodruff C, Keilman J. Text messaging reduces analgesic requirements during surgery. Pain Med. 2015 Apr;16(4):667-72. doi: 10.1111/pme.12610. Epub 2014 Dec 19.
Results Reference
background

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Effects of Social Presence and Perception in Virtual Reality on Pain

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