SPP2: Effects of Social Presence and Perception in Virtual Reality on Pain (SPP)

Sponsor
Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05335057
Collaborator
(none)
75
1
4
13.3
5.6

Study Details

Study Description

Brief Summary

This experiment aims to examine the effects of social interaction with close others or strangers in virtual reality or through a video-conferencing call, on pain threshold in healthy volunteers in an induced pain task.

In a within-subjects study, participants will complete a series of induced-pain heat ramps in four conditions. These conditions are 1. alone in virtual reality 2. with a close friend or family member in virtual reality 3. with a stranger in virtual reality 4. with the same close friend or family member in a video call.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: VR Close Other
  • Behavioral: VR Alone
  • Behavioral: VR Stranger
  • Behavioral: Video Close Other
N/A

Detailed Description

Some of the earliest clinical uses of virtual reality were as a distractor for patients experiencing pain. 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. In a previous study, we found that participants in an induced pain task demonstrated higher pain thresholds when they were interacting socially with a stranger compared to when they were alone (Won, Pandita and Kruzan, 2020).

In this study, we follow up on these results. First, we aim to replicate the previous finding of social interactions, overall, increasing pain tolerance. Second, we aim to compare the potential effects of interacting with a stranger compared to a "close other," defined as a friend or family member. Third, we compare social interactions in virtual reality compared to video. Fourth, we examine whether cortisol is linked with pain threshold.

METHODS AND RESEARCH STRATEGY: Our previous study used 75 participants, and since this is the closest study to our current research design, we will retain this number as our target. We will work with a student sample of convenience.

Each participant will experience four conditions in a random order: 1. alone in virtual reality 2. with a close friend or family member in virtual reality 3. with a stranger in virtual reality 4. with the same close friend or family member in a video call. Each condition will take place in a different virtual environment.

Participants will be stably seated, and observed by a research assistant, as they experience each condition. During each condition, participants will complete an induced pain task using a Medoc TSA-2001/Model Q-Sense thermode. Prior to experiencing the four experimental conditions, participants will complete a "practice" induced pain task while viewing a different 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 other conversational partners. All conditions will be presented in a randomized order to control for order effects. 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. After each survey, 15 minutes after each pain task, a saliva sample for cortisol will be taken.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Each participant will experience all four conditions, in a random orderEach participant will experience all four conditions, in a random order
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effects of Social Presence and Perception on Pain: Comparing Close Others to Strangers and VR to Video Conferencing
Actual Study Start Date :
Oct 22, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Time 1

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

Behavioral: VR Close Other
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments while chatting with the friend or family member who accompanied them to the lab

Behavioral: VR Alone
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments alone

Behavioral: VR Stranger
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments while chatting with a stranger

Behavioral: Video Close Other
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they chat with the friend or family member who accompanied them to the lab using a video-conferencing tool

Active Comparator: Time 2

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

Behavioral: VR Close Other
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments while chatting with the friend or family member who accompanied them to the lab

Behavioral: VR Alone
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments alone

Behavioral: VR Stranger
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments while chatting with a stranger

Behavioral: Video Close Other
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they chat with the friend or family member who accompanied them to the lab using a video-conferencing tool

Active Comparator: Time 3

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

Behavioral: VR Close Other
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments while chatting with the friend or family member who accompanied them to the lab

Behavioral: VR Alone
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments alone

Behavioral: VR Stranger
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments while chatting with a stranger

Behavioral: Video Close Other
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they chat with the friend or family member who accompanied them to the lab using a video-conferencing tool

Experimental: Time 4

Participant will be randomly assigned to the remainingintervention; either Near Non-Social, Near Social, Far Non-Social, or Far Social

Behavioral: VR Close Other
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments while chatting with the friend or family member who accompanied them to the lab

Behavioral: VR Alone
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments alone

Behavioral: VR Stranger
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience one of four randomly assigned virtual environments while chatting with a stranger

Behavioral: Video Close Other
Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they chat with the friend or family member who accompanied them to the lab using a video-conferencing tool

Outcome Measures

Primary Outcome Measures

  1. Pain threshold in degrees tolerated at end of trial [The beginning and end of each trial < 90 seconds]

    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

  1. Cortisol levels [15 minutes between samples]

    Cortisol levels derived from saliva samples

  2. Self-reported social presence [Experience and subsequent survey time 5-15 minutes]

    Questionnaire of self-reported feelings of social presence with the conversational partner

  3. Self-reported environmental presence [Experience and subsequent survey time 5-15 minutes]

    Questionnaire of self-reported feelings of environmental presence with the conversational partner

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cornell Virtual Embodiment Lab Ithaca New York United States 14853

Sponsors and Collaborators

  • Cornell University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cornell University
ClinicalTrials.gov Identifier:
NCT05335057
Other Study ID Numbers:
  • 1701006910-2
First Posted:
Apr 19, 2022
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cornell University

Study Results

No Results Posted as of Apr 19, 2022