NCT00701571

Brief Summary

The purpose of this study is to compare the analgesic efficacy of three different types of video/audio distraction in normal volunteers subjected to carefully controlled and non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of a lumbar puncture. Two of the distraction techniques include immersive virtual reality (VR). The most efficacious distraction technique will be used in a subsequent clinical study in cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable pain

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

September 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

4.3 years

First QC Date

June 17, 2008

Last Update Submit

September 12, 2011

Conditions

Pain

Keywords

Virtual RealityOncologyLumbar puncture

Outcome Measures

Primary Outcomes (1)

  • To compare positional techniques and differing types of VR presentation (immersive vs. low tech). We will also compare age cohorts (18-21, 40-60, and older than 60 years).

    upon completion of data collection

Study Arms (1)

1

EXPERIMENTAL

3 cohorts: 18-21 years, 40-60 years, and older than 60 years

Procedure: Virtual Reality distraction

Interventions

Virtual Reality distractionPROCEDURE

Virtual Reality involves the participant wearing a helmet with sight and sound. the visual provided is a type of immersive video game, the game used is "Snow World". In some cases the participant will be exposed to 3D representation of the game, and in other cases a lower tech version with less immersive qualities.

1

Eligibility Criteria

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

You may qualify if:

  • healthy men and women
  • y, 40-60y, or older than 60y

You may not qualify if:

  • a predisposition to motion sickness
  • unusual sensitivity or lack of sensitivity to pain
  • chronic pain
  • peripheral neuropathy
  • sensitive skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

PainNeoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Samuel R Sharar, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

September 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 13, 2011

Record last verified: 2011-09

Locations

US(1)