NCT00163917

Brief Summary

The purpose of this study is to evaluate whether a sub-population of patients with burn injuries needing dressing changes respond to virtual reality (VR) utilising relaxation themes with improved pain and anxiety scores, when added to PCA morphine and background analgesic therapy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

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, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

March 15, 2007

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

March 14, 2007

Conditions

AnxietyPain

Keywords

HypnosisAnalgesia

Outcome Measures

Primary Outcomes (2)

  • Association between hypnotic susceptibility and pain scores

  • Association between hypnotic susceptibility and anxiety scores

Secondary Outcomes (6)

  • Measurement of pain by visual analogue scale (VAS)

  • Measurement of anxiety by Burns Specific Anxiety Rating by VAS

  • Rating of hypnotic susceptibility and morphine use

  • Satisfaction rating

  • Morphine use

  • +1 more secondary outcomes

Interventions

Virtual reality relaxationDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Burn injury
  • Scheduled for painful dressing changes
  • Conscious
  • Comprehension of PCA and virtual reality device
  • Comprehension of the English language

You may not qualify if:

  • Patient refusal
  • Psychotic disease
  • Paranoid disease
  • Unstable dissociative disorder
  • Borderline personality disorder
  • Phobias relevant to water/drowning
  • Epilepsy/propensity to fitting
  • Morphine allergy
  • Acute brain syndrome
  • Chronic brain syndrome
  • Physically unable to administer PCA
  • Severe burns involving the head
  • Visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3181, Australia

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersPainAgnosia

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Alex Konstantatos, MBBS

    The Alfred

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Konstantatos, MBBS, FANZCA

CONTACT

03 92763176a.konstantatos@alfred.org.au

Margaret E Angliss, BN

CONTACT

03 92763176m.angliss@alfred.org.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

September 1, 2004

Last Updated

March 15, 2007

Record last verified: 2005-09

Locations

AU(1)