Immersive Healing: The Therapeutic Potential of Virtual Reality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-21

Study Completion Date

2026-10-31

Brief Summary

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Phantom limb pain (PLP) is a significant and pervasive issue among upper limb amputees, severely impacting their quality of life. The literature delineating prevalence of upper versus lower limb amputations is limited, but the prevalence of total amputations in the United States is estimated to reach 3 million individuals by 2050, with approximately 185,000 new cases annually. PLP affects 60-68% of these patients, leading to heightened levels of anxiety, depression, and reduced overall well-being.

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Detailed Description

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Although studies exploring the efficacy of VR therapy for PLP have reported positive outcomes, several limitations, such as small sample sizes, lack of randomization, and inconsistent treatment protocols, have impeded widespread adoption of these innovative approaches. Additionally, the literature does not sufficiently delineate which aspects of the phantom limb experience may be addressed with VR therapy. To overcome these limitations and optimize treatment efficacy, it is crucial to gain a comprehensive understanding of the phantom limb experience, including both somatosensory and kinesthesia-related symptoms. Additionally, this study will address these limitations by employing a larger sample size, rigorous methodology, and a standardized treatment protocol.

Conditions

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Phantom Limb Pain (PLP)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Pre- and post-intervention surveys will be used to assess the effects of virtual reality (VR) therapy on the phantom limb experience in the intervention group. Matched controls from the registry will be surveyed on their phantom limb symptoms at matching time intervals to the intervention group for comparison.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality (VR) Intervention

Individuals undergoing virtual reality therapy intervention

Group Type EXPERIMENTAL

virtual reality therapy

Intervention Type DEVICE

6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys

Matched Control

The matched controls will receive standard care without the VR intervention

Group Type SHAM_COMPARATOR

matched control group

Intervention Type OTHER

taking the same surveys as the VR intervention group on a weekly basis for 6 weeks

Interventions

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virtual reality therapy

6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys

Intervention Type DEVICE

matched control group

taking the same surveys as the VR intervention group on a weekly basis for 6 weeks

Intervention Type OTHER

Other Intervention Names

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VR Intervention control group

Eligibility Criteria

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Inclusion Criteria

* History of major limb amputation
* Age \> 18 years old
* Presence of phantom limb pain or negative phantom sensation(s)

Exclusion Criteria

* Active mental illness, neurological disease, or cognitive impairment that would interfere with survey completion
* Those without phantom limb pain or negative phantom limb sensations
* Non-English speaking

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No