NCT03157362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2018

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

May 9, 2017

Last Update Submit

January 24, 2022

Conditions

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 (2)

  • Self-reported social presence

    ~15 minutes at the end of each trial

  • Self-reported environmental presence

    ~15 minutes at the end of each trial

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

Other: Near Non-SocialOther: Near SocialOther: Far Non-SocialOther: Far Social

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

Other: Near Non-SocialOther: Near SocialOther: Far Non-SocialOther: Far Social

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

Other: Near Non-SocialOther: Near SocialOther: Far Non-SocialOther: Far Social

Time 4

ACTIVE COMPARATOR

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

Other: Near Non-SocialOther: Near SocialOther: Far Non-SocialOther: Far Social

Interventions

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.

Time 1Time 2Time 3Time 4

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.

Time 1Time 2Time 3Time 4

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.

Time 1Time 2Time 3Time 4

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.

Time 1Time 2Time 3Time 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell Virtual Embodiment Lab

Ithaca, New York, 14853, United States

Location

Related Publications (8)

  • 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.

    PMID: 10692634BACKGROUND
  • F. P. Brooks Jr, 1990. Virtual reality at work. Human Machine Interfaces for Teleoperators and Virtual Environments, 67.

    BACKGROUND
  • 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.

    PMID: 12909433BACKGROUND
  • 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.

    PMID: 15803164BACKGROUND
  • 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.

    PMID: 15327820BACKGROUND
  • 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.

    PMID: 23365736BACKGROUND
  • 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.

    PMID: 12651995BACKGROUND
  • 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.

    PMID: 25529995BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Each participant will experience four conditions, in a random order, crossing "near" and "far" virtual environments, and social presence or no social presence.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 17, 2017

Study Start

February 1, 2018

Primary Completion

November 8, 2018

Study Completion

November 8, 2018

Last Updated

February 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations