NCT04572425

Brief Summary

The purpose of this research project is to evaluate the impact of virtual reality therapy on mitigating heart failure pain in hospitalized patients with heart failure and compare this impact to that of 2-dimensional guided imagery distraction therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

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

October 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

September 3, 2020

Last Update Submit

September 25, 2020

Conditions

Heart Failure，CongestiveAcute PainChronic Pain

Outcome Measures

Primary Outcomes (1)

  • Self reported pain score

    Likert scale 0 (no pain) to 10 (worst pain)

    Immediately after assigned intervention

Secondary Outcomes (4)

  • Quality of life score

    Immediately after assigned intervention

  • Self reported distress

    Immediately after assigned intervention

  • Ease of intervention ("How easy was this technology for you to use?") -- this single question designed for this study

    Immediately after assigned intervention

  • Acceptability of intervention ("Would you use this intervention again?") -- this single question designed for this study

    Immediately after assigned intervention

Study Arms (2)

Guided imagery

ACTIVE COMPARATOR

10 minutes of guided imagery (using Apple iPad and headphones, subject watches 10 minute video of a guided-imagery session depicting a peaceful walk through a forest with instrumental background music and 2-dimensional imagery)

Other: Guided imagery

Virtual reality

EXPERIMENTAL

10 minutes of virtual reality (using study-administered Facebook Oculus Go VR headset with headphones, subject engages with VR application Forest of Serenity (Holosphere VR®, Birmingham, UK) that features a forest environment with voice narration that can be played in a seated or fixed position.

Other: Virtual reality

Interventions

Guided imageryOTHER

10 minutes of guided imagery experience delivered on tablet

Guided imagery
Virtual realityOTHER

10 minutes of virtual reality experience delivered by Facebook Oculus Go VR device

Virtual reality

Eligibility Criteria

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

You may qualify if:

  • hospitalized at study institution
  • primary diagnosis of ACC/AHA Stage C or D heart failure
  • reports pain on 0-10 Likert scale at least 4/10 or greater

You may not qualify if:

  • participant already uses virtual reality for personal use
  • intractable nausea/vomiting
  • history of motion sickness
  • history of seizures or epilepsy
  • have cranial structure abnormalities that prevent use of VR headset
  • currently enrolled in a palliative care or pain management study
  • on contact isolation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (2)

  • Stewart D, Mete M, Groninger H. Virtual reality for pain management in patients with heart failure: Study rationale and design. Contemp Clin Trials Commun. 2019 Oct 12;16:100470. doi: 10.1016/j.conctc.2019.100470. eCollection 2019 Dec.

    PMID: 31650079BACKGROUND

  • Groninger H, Stewart D, Fisher JM, Tefera E, Cowgill J, Mete M. Virtual reality for pain management in advanced heart failure: A randomized controlled study. Palliat Med. 2021 Dec;35(10):2008-2016. doi: 10.1177/02692163211041273. Epub 2021 Aug 25.

    PMID: 34431398DERIVED

MeSH Terms

Conditions

Heart FailureAcute PainChronic Pain

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hunter Groninger, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

October 1, 2020

Study Start

October 1, 2018

Primary Completion

March 29, 2020

Study Completion

March 30, 2020

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)