NCT06871423

Brief Summary

The effect of Virtual Reality on pain and memory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

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

Study Start

First participant enrolled

January 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 1, 2025

Last Update Submit

March 10, 2025

Conditions

Keywords

virtual realitypaindistraction

Outcome Measures

Primary Outcomes (2)

  • Pain Memory Recall Test

    After each brief thermal stimulus set, participants were asked to recall the exact pattern of the most recent sequence of 5 brief thermal stimuli, recalled in exact order, via our five question "pain memory recall test" (min = 0%, max -= 100% correct). Lower % correct scores mean less accurate memory (poorer outcome).

    After each brief pain stimulus set, participants performed a brief distractor task before completing the Pain Memory Recall Test. The Pain Memory Recall Test was completed within 5 minutes after each brief thermal stimulus set.

  • Participants subjective rating of the accuracy of their memory for painful stimuli

    Using a graphic rating scale, on a scale from zero (min) to 10 (max), participants rated how accurately they could remember their pain during No Virtual Reality vs during Virtual Reality. Higher scores indicated higher accuracy and more positive outcome.

    measured within 10 minutes after each pain stimulus set

Secondary Outcomes (1)

  • Presence ratings using Graphic Rating Scales

    measured within 10 minutes after participant was in virtual reality

Study Arms (2)

No Virtual Reality

NO INTERVENTION

No Virtual Reality during painful stimuli

Immersive VR

EXPERIMENTAL

immersive virtual reality during painful stimuli

Behavioral: distraction

Interventions

distractionBEHAVIORAL

distraction via virtual reality game named "Waltz of the Wizards" aka magic bowl.

Immersive VR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be English speaking (but English does not necessarily need to be native/first language).
  • must be willing to follow our UW approved instructions,

You may not qualify if:

  • Not capable of indicating pain intensity
  • Not capable of filling out study measures
  • Non-English-speaking
  • Extreme susceptibility to motion sickness
  • Seizure history
  • Unusual sensitivity or lack of sensitivity to pain
  • Sensitive skin
  • sensitive feet
  • migraines
  • cold symptoms
  • Diabetes
  • Or if you are under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bone LengtheningOrthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Hunter G Hoffman, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Using a repeated measures within-subject crossover design with treatment order randomized, with healthy volunteers,
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Virtual Reality Research Center at the Human Photonics Lab; Research Scientist:Dept of Mechanical Engineering

Study Record Dates

First Submitted

March 1, 2025

First Posted

March 12, 2025

Study Start

January 3, 2025

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

All data is already de-identified. Only de-identified data will be shared. The datasets used and/or analyzed during the current study will be made available from the corresponding author on reasonable request. All de-identified IPD that underlie our results in a publication will be shared.

Time Frame
Beginning 3 months after the publication of the results, and ending 3 years after the publication of results
Access Criteria
All data is already de-identified. Only de-identified data will be shared. The datasets used and/or analyzed during the current study will be made available from the corresponding author on reasonable request. All de-identified IPD that underlie our results in a publication will be shared.

Locations