Virtual Reality for Cancer Pain Management

NCT04572074 | Completed

• 1 other identifier: 2017-240
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research project is to evaluate the impact of virtual reality therapy on mitigating cancer pain in hospitalized patients with cancer and compare this impact to that of 2-dimensional guided imagery distraction therapy. The purpose is also to evaluate acceptability of and satisfaction with virtual reality therapy and to examine racial and cultural preferences related to virtual reality and guided imagery thematic content.

Conditions

Cancer; Cancer Pain

Outcome Measures

Primary Outcomes (1)

• Change in self-reported pain score from baseline to immediately after assigned intervention

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

  Baseline and again immediately after assigned intervention

Secondary Outcomes (6)

• Change in self-reported distress from baseline to immediately after assigned intervention

  Baseline and immediately after intervention, 24 hours after intervention

• Change in self-reported quality of life from baseline to immediately after assigned intervention

  Immediately after assigned intervention

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

  Immediately after intervention

• Level of immersion experienced in virtual reality arm

  Immediately after intervention (virtual reality arm only)

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

  Immediately after assigned intervention

Study Arms (2)

Arm 1 (Guided imagery)

ACTIVE COMPARATOR

10 minutes of guided imagery experience

Other: Guided imagery

Arm 2 (Virtual reality)

EXPERIMENTAL

10 minutes of virtual reality experience

Other: Virtual reality

Interventions

Guided imagery OTHER

10 minutes of guided imagery experience

Arm 1 (Guided imagery)

Virtual reality OTHER

10 minutes of virtual reality experience

Arm 2 (Virtual reality)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hospitalized, with primary diagnosis of cancer
• age 18 and older
• report moderate-severe pain (at least 4 out of 10 where pain is rated on a Likert scale between zero and 10) in the previous 24 hours

You may not qualify if:

• already use VR 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

MedStar Washington Hospital Center

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

Location

MeSH Terms

Conditions

Neoplasms; Cancer Pain

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: October 1, 2020
• Study Start: February 1, 2020
• Primary Completion: September 29, 2022
• Study Completion: September 30, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)