NCT03528668

Brief Summary

This study will evaluate the acceptability, use, and general effect that exposure to virtual reality has on hospitalized patients reporting at least one discomfort including recent or current moderate-severe pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2018

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

April 23, 2018

Last Update Submit

February 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Pain

    Change in subjective report of pain measured on a visual analog scale

    Change between baseline and 5 minutes after intervention

Secondary Outcomes (2)

  • Change in Heart Rate

    Change between baseline and 5 minutes after intervention

  • Change in Anxiety

    Change between baseline and 5 minutes after intervention

Interventions

Exposure to Virtual Reality program for up to 30 minutes

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients on adult general care medical/surgical units, regardless of genders will be identified via an existing pain assessment dashboard that allows the investigator to identify patients with 3 or episodes of moderate-severe pain in the prior 24-hour period. The investigator will scan the report for potential subjects in accordance with participating units, inclusion and exclusion criteria. The front-line nurse manager and registered Nurse caring for to patient will be contacted for appropriateness to consider including and the timing when the patient can be approached without interrupting planned tests, treatments or workflow.

You may qualify if:

  • English-speaking
  • Inpatients on a general care unit
  • Current or recorded moderate to severe pain in past 24 hours

You may not qualify if:

  • Receiving palliative/end of life care;
  • Admitted for treatment of psychiatric or mental health disorder
  • History of seizure or stroke
  • Legally blind or deaf
  • Moderate or severe cognitive impairment
  • Head wounds or bandages
  • On isolation precautions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Paul M Arnstein, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse Specialist

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 18, 2018

Study Start

April 16, 2018

Primary Completion

October 12, 2018

Study Completion

October 12, 2018

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Data will be collected without individual patient identifiers. Patient identifiers will be logged and separately in a locked confidential file.

Locations