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

NCT05335057 | Completed DMC

• 1 other identifier: 1701006910-2
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Threshold

Keywords

virtual reality

Outcome Measures

Primary Outcomes (1)

• 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.

  The beginning and end of each trial < 90 seconds

Secondary Outcomes (3)

• Cortisol levels

  15 minutes between samples

• Self-reported Social Presence

  Experience and subsequent survey time 5-15 minutes

• Self-reported Environmental Presence

  Experience and subsequent survey time 5-15 minutes

Study Arms (4)

Time 1

ACTIVE COMPARATOR

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; Behavioral: VR Alone; Behavioral: VR Stranger; Behavioral: Video Close Other

Time 2

ACTIVE COMPARATOR

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; Behavioral: VR Alone; Behavioral: VR Stranger; Behavioral: Video Close Other

Time 3

ACTIVE COMPARATOR

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; Behavioral: VR Alone; Behavioral: VR Stranger; Behavioral: Video Close Other

Time 4

EXPERIMENTAL

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

Behavioral: VR Close Other; Behavioral: VR Alone; Behavioral: VR Stranger; Behavioral: Video Close Other

Interventions

VR Close Other BEHAVIORAL

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

Time 1; Time 2; Time 3; Time 4

VR Alone BEHAVIORAL

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

Time 1; Time 2; Time 3; Time 4

VR Stranger BEHAVIORAL

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

Time 1; Time 2; Time 3; Time 4

Video Close Other BEHAVIORAL

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

Time 1; Time 2; Time 3; Time 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting Adult

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Cornell Virtual Embodiment Lab

Ithaca, New York, 14853, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will experience all four conditions, in a random order

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: October 22, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The SAP is already posted to Open Science Framework. Once published the data will be available on the CCSS/CRADC archives indefinitely.
• Access Criteria: Anonymized data will be available to any who request it. The full data set will be available upon submission of a valid IRB protocol and promise to destroy data after use.

Locations

US (1)