Effects of Social Presence and Perception in Virtual Reality on Pain
NCT ID: NCT03157362
Last Updated: 2022-02-07
Study Results
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Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2018-02-01
2018-11-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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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
Near Non-Social
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.
Near Social
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.
Far Non-Social
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.
Far Social
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 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
Near Non-Social
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.
Near Social
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.
Far Non-Social
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.
Far Social
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 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
Near Non-Social
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.
Near Social
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.
Far Non-Social
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.
Far Social
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 4
Participant will complete the remaining intervention; either Near Non-Social, Near Social, Far Non-Social, or Far Social
Near Non-Social
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.
Near Social
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.
Far Non-Social
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.
Far Social
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.
Interventions
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Near Non-Social
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.
Near Social
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.
Far Non-Social
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.
Far Social
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
Yes
Sponsors
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Weill Medical College of Cornell University
OTHER
Cornell University
OTHER
Responsible Party
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Locations
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Cornell Virtual Embodiment Lab
Ithaca, New York, United States
Countries
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References
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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.
F. P. Brooks Jr, 1990. Virtual reality at work. Human Machine Interfaces for Teleoperators and Virtual Environments, 67.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1701006910
Identifier Type: -
Identifier Source: org_study_id
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