Healing Hearts of Hospitalized Patients

NCT ID: NCT06935604

Last Updated: 2025-09-26

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2026-09-14

Brief Summary

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The study aims to study virtual reality (VR) facilitation with adult inpatients using VR as a way to alter pain perception and reduce emotional distress during their hospitalization. Specifically, this study will evaluate the outcomes of patients who experience VR with and without a trained facilitator as a form of escapism.

Detailed Description

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Conditions

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Pain Anxiety Stress Loneliness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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VR a trained facilitator.

Group Type ACTIVE_COMPARATOR

VR with a trained facilitator

Intervention Type BEHAVIORAL

Intervention Group 1 - VR with a facilitator:

Each participant in the intervention group will undergo a structured VR session, consisting of:

Duration: 20 minutes Content: Immersive VR experience designed to promote relaxation and reduce pain.

Facilitator training: The facilitator group will include trained healthcare professionals skilled in VR technology, C-I-CARE, and empathetic patient engagement. All facilitators also complete the Creative \& Healing Arts Heart-to-Heart training which includes observation, empathy training, and reflection to support complex communication, and companionship needs of adult patients .

VR without a trained facilitator.

Group Type EXPERIMENTAL

VR without a trained facilitator.

Intervention Type BEHAVIORAL

Intervention Group 2 - VR without an inperson facilitator:

Each participant in the intervention groups will undergo a structured VR session, consisting of:

Duration: 20 minutes Content: Immersive VR experience designed to promote relaxation and reduce pain.

Instructional video: A research assistant will use C-I-CARE to give the patient an instructional video and the headset to engage in the VR technology.

Patients will take a surveys before and after the intervention

Interventions

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VR with a trained facilitator

Intervention Group 1 - VR with a facilitator:

Each participant in the intervention group will undergo a structured VR session, consisting of:

Duration: 20 minutes Content: Immersive VR experience designed to promote relaxation and reduce pain.

Facilitator training: The facilitator group will include trained healthcare professionals skilled in VR technology, C-I-CARE, and empathetic patient engagement. All facilitators also complete the Creative \& Healing Arts Heart-to-Heart training which includes observation, empathy training, and reflection to support complex communication, and companionship needs of adult patients .

Intervention Type BEHAVIORAL

VR without a trained facilitator.

Intervention Group 2 - VR without an inperson facilitator:

Each participant in the intervention groups will undergo a structured VR session, consisting of:

Duration: 20 minutes Content: Immersive VR experience designed to promote relaxation and reduce pain.

Instructional video: A research assistant will use C-I-CARE to give the patient an instructional video and the headset to engage in the VR technology.

Patients will take a surveys before and after the intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 years and above
* Able to provide informed consent
* Able to follow commands
* Adequate motor skills for upper extremities to operate VR equipment
* Clinically stable
* English speaking
* Willing to engage in VR

Exclusion Criteria

* Severe cognitive impairment
* Facial trauma prohibiting headset use
* Physical limitations in facial, neck, upper extremities that hinder use of VR equipment
* Aggression or violence
* Harm to self or others
* Isolation room
* History of seizures or other neurological conditions
* Severe motion sickness
* Active nausea
* Severe visual impairment
* Severe cognitive impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Caruso

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford Health Care (SHC)

Palo Alto, California, United States

Site Status

Countries

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United States

Central Contacts

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Thomas Caruso, MD, PhD

Role: CONTACT

6504970927

Man Yee Suen, MD

Role: CONTACT

6504970927

Other Identifiers

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80473

Identifier Type: -

Identifier Source: org_study_id

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