Healing Hearts of Hospitalized Patients

Not Applicable

Not yet recruiting

• Conditions: Pain; Anxiety; Stress; Loneliness

• Registration Number: NCT06935604
• Lead Sponsor: Stanford University

Brief Summary

The study aims to investigate therapeutic virtual reality (VR) facilitation with adult inpatients using VR as an analgesic and anxiolytic during their hospitalization. Specifically, this study will evaluate the outcomes of patients who experience therapeutic VR with and without a trained facilitator as a form of escapism.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-12
• Study First Submitted QC: 2025-04-12
• Last Update Submitted: 2025-04-12
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Start: 2025-06-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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
• Experiencing anxiety related to their medical condition as evidenced by a VAS-A score >4 at time of enrollment.
• English speaking
• Willing to engage in Therapeutic 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in anxiety levels	baseline, immediately after the intervention	Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.

Secondary Outcome Measures

Name	Time	Method
Change in pain levels	baseline, immediately after the intervention	Participants will complete the Numerical Rating Pain Scale (NRPS) immediately following each trial, where they rank pain sensitivity on an ordinal scale from 0 = no pain to 10 = worst pain.
Participant Satisfaction as Measured by a Self-Developed Satisfaction Survey	immediately after the intervention	Participants will complete the Self-Developed Satisfaction survey. The instrument includes 8 closed-ended items with varying response formats. In addition, the questionnaire includes one open-ended question that invites participants to provide qualitative feedback on their experience.
The Perceived Stress Scale	Baseline	Participants will complete the Perceived Stress Scale-10. It is a five-point Likert-type scale and consists of 10 items. Participants rate each item on a scale ranging from "Never (0)" to "Very often (4)".
Change of Visual Analog Scale for Stress (VAS-Stress)	baseline, immediately after the intervention	Participants will complete the Visual Analog Scale for Stress (VAS-Stress). Visual analog scale to assess the perceived stress on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100)
State-Trait Anxiety Inventory	baseline, immediately after the intervention	The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety.
Change in Loneliness as Measured by the UCLA 3-Item Loneliness Scale	baseline, immediately after the intervention	The UCLA 3-Item Loneliness Scale is a brief, validated self-report questionnaire used to assess subjective feelings of loneliness and social isolation. It consists of three items derived from the original UCLA Loneliness Scale. Each item is rated on a 3-point Likert scale (1 = Hardly Ever, 2 = Some of the Time, 3 = Often), yielding a total score ranging from 3 to 9. Higher scores indicate greater loneliness.

Trial Locations

Locations (1)

Stanford Health Care (SHC); 🇺🇸 Palo Alto, California, United States