Trial Outcomes & Findings for Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA (NCT NCT03662607)

NCT ID: NCT03662607

Last Updated: 2025-03-11

Results Overview

The primary outcome of this study is patient anxiety, as measured by the State Trait Anxiety Inventory (STAI) score. STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 180 participants
• Primary outcome timeframe: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.
• Results posted on: 2025-03-11

Participant Flow

Participant milestones

Measure	Control Standard preprocedural education	VR Group (Treatment) Stanard preprocedural education plus viewing of virtual reality video
Overall Study STARTED	91	89
Overall Study COMPLETED	91	89
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control n=91 Participants Standard preprocedural education	VR Group (Treatment) n=89 Participants Standard preprocedural education plus viewing of virtual reality video	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=91 Participants	0 Participants n=89 Participants	0 Participants n=180 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=91 Participants	42 Participants n=89 Participants	88 Participants n=180 Participants
Age, Categorical >=65 years	45 Participants n=91 Participants	47 Participants n=89 Participants	92 Participants n=180 Participants
Age, Continuous	64 years STANDARD_DEVIATION 8.52 • n=91 Participants	64 years STANDARD_DEVIATION 8 • n=89 Participants	64 years STANDARD_DEVIATION 8 • n=180 Participants
Sex: Female, Male Female	30 Participants n=91 Participants	35 Participants n=89 Participants	65 Participants n=180 Participants
Sex: Female, Male Male	61 Participants n=91 Participants	54 Participants n=89 Participants	115 Participants n=180 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	91 Participants n=91 Participants	89 Participants n=89 Participants	180 Participants n=180 Participants

PRIMARY outcome

Timeframe: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.

The primary outcome of this study is patient anxiety, as measured by the State Trait Anxiety Inventory (STAI) score. STAI is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Outcome measures

Measure	Control n=91 Participants Standard preprocedural education	VR Group (Treatment) n=89 Participants Standard preprocedural education plus viewing of virtual reality video
Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI)	69.81 Mean STAI score Standard Deviation 17.11	65.71 Mean STAI score Standard Deviation 15.22

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ryan Madder

Spectrum Health

Phone: 6163916660

Email: stephen.orey@corewellhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place