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Behavioral Intervention

Virtual Reality Assisted Guided Imagery (VRAGI ) for Cancer Pain

N/A

Waitlist Available

Led By Teny Henry Gomez, MD

Research Sponsored by Prisma Health-Upstate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Baseline pain score Edmonton Symptom Assessment Scale (ESAS) ≥ 4 (mean score during the screening week).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily assessed in a 6-week period. comparing the change from study baseline to day 7, day 14, day 21 and day 42 in mme of prescribed medication.

Awards & highlights

Study Summary

This trial will test whether Virtual Reality Assisted Guided Imagery (VRAGI) is an effective, feasible, and safe alternative pain treatment modality for patients with advanced cancer.

Eligible Conditions

Cancer Pain
Cancer
Virtual Reality
Depression and Anxiety

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have a baseline pain score of 4 or higher on the Edmonton Symptom Assessment Scale during the screening week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily assessed in a 6-week period. comparing the change from study baseline to day 7, day 14, day 21 and day 42 in mme of prescribed medication.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily assessed in a 6-week period. comparing the change from study baseline to day 7, day 14, day 21 and day 42 in mme of prescribed medication.

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily assessed in a 6-week period. comparing the change from study baseline to day 7, day 14, day 21 and day 42 in mme of prescribed medication. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Chane in Pain score

Secondary outcome measures

Change in Anxiety score, Edmonton Symptom Assessment Scale (ESAS)

Change in Depression score, Edmonton Symptom Assessment Scale (ESAS)

Median acceptability score.

+3 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Virtual Reality Assisted Guided Imagery (VRAGI )Active Control1 Intervention

20 participants will be randomized to this arm. Participants in this arm will experience the immersive VR guided imagery on VR Head Mounted Displays (Meta Quest 2). They will experience video content and the accompanying guided imagery and nature soundscapes.

Group II: Laptop Assisted Guided Imagery (Laptop AGI)Active Control1 Intervention

20 participants will be randomized to this arm. Participants in this arm will experience the VR content on laptops. They will not receive the VRHMDs. They will experience video content and the accompanying guided imagery and nature soundscapes on a laptop.

Group III: Laptop no Guided Imagery or other audio (Laptop no GI or other audio)Placebo Group1 Intervention

20 participants will be randomized to this arm. Participants in this arm will experience the VR content on laptops. They will not receive the VRHMDs. They will experience only the video content on a laptop and will no experience the accompanying guided imagery or nature soundscapes.

Group IV: Virtual Reality No Guided Imagery or other audio ( VR No GI or other audio)Placebo Group1 Intervention

20 participants will be randomized to this arm. Participants in this arm will experience the immersive VR visual content on VR Head Mounted Displays (Meta Quest 2) but will not experience the accompanying guided imagery narration or nature soundscapes.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Clemson UniversityOTHER

33 Previous Clinical Trials

5,813 Total Patients Enrolled

Prisma Health-UpstateLead Sponsor

82 Previous Clinical Trials

42,858 Total Patients Enrolled

Teny Henry Gomez, MDPrincipal InvestigatorPrisma Health-Upstate

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met in order to join the experiment?

"This trial calls for 80 participants aged 18 to 65, who experience cancer-related pain. In addition, they must possess the following qualifications: advanced incurable cancer with no plans of resection during the study period, a baseline Edmonton Symptom Assessment Scale rating of 4 or greater, and access to either an Android/iOS smartphone or personal laptop computer (not a tablet). Furthermore, individuals need to be able to comprehend both spoken and written English as well as willingly provide consent for their participation in this investigation."

Answered by AI

Are there remaining positions available for candidates of this scientific exploration?

"The clinicaltrials.gov website indicates that this research is not presently enrolling participants, despite its initial posting on October 1st 2022 and the most recent update on August 31st 2022. However, there are currently 173 other medical studies actively seeking enrolment."

Answered by AI

Is the minimum age requirement for eligibility in this trial above 30?

"This trial is open to patients within the age range of 18 and 65. For those under 18, there are 33 relevant studies, while 140 can be found for those over the age threshold."

Answered by AI

Recent research and studies

Supportive Care in CancerJournal

A Positive Psychological Intervention Using Virtual Reality for Patients with Advanced Cancer in a Hospital Setting: A Pilot Study to Assess Feasibility

Baños, Rosa M., Macarena Espinoza, Azucena García-Palacios, José M. Cervera, Gaspar Esquerdo, Enrique Barrajón, and Cristina Botella. 2012. “A Positive Psychological Intervention Using Virtual Reality for Patients with Advanced Cancer in a Hospital Setting: A Pilot Study to Assess Feasibility”. Supportive Care in Cancer. Springer Science and Business Media LLC. doi:10.1007/s00520-012-1520-x.

BMJ OpenJournal

Home-based Virtual Reality for Chronic Pain: Protocol for an Nih-supported Randomised-controlled Trial

Birckhead, Brandon, Sam Eberlein, Genie Alvarez, Rebecca Gale, Taylor Dupuy, Katherine Makaroff, Garth Fuller, et al.. 2021. “Home-based Virtual Reality for Chronic Pain: Protocol for an Nih-supported Randomised-controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-050545.

Integrative Cancer TherapiesJournal

Meta-analysis of the Efficacy of Virtual Reality–based Interventions in Cancer-related Symptom Management

Zeng, Yingchun, Jun-E Zhang, Andy S. K. Cheng, Huaidong Cheng, and Jeffrey Scott Wefel. 2019. “Meta-analysis of the Efficacy of Virtual Reality–based Interventions in Cancer-related Symptom Management”. Integrative Cancer Therapies. SAGE Publications. doi:10.1177/1534735419871108.

clinicaltrials.govStudy