NCT07222839

Brief Summary

The purpose of this quasi-experimental study is to examine the effect of visually immersive preoperative education on levels of anxiety and patient outcomes in patients undergoing cardiothoracic (open heart) surgery

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

September 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

March 4, 2026

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

September 23, 2025

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Anxiety relief (self-report measure 1 - State-Trait Anxiety Inventory)

    Patient's anxiety will be measured using the 20-item State-Trait Anxiety Inventory (STAI) (state scale only) (higher scores indicate higher anxiety), taken before and after preoperative education is received.

    30 minutes

  • Anxiety relief (self-report measure 2 - Visual Analog Scale for Anxiety)

    Patient's anxiety will be measured using the Visual Analog Scale for Anxiety (VAS-A), a slider scale of 0 - 100 is used to self-report anxiety (0 = not anxious and 100 = extremely anxious), taken before and after preoperative education is received.

    30 minutes

Secondary Outcomes (7)

  • Anxiety relief (physiological measure 1 - blood pressure)

    30 minutes

  • Anxiety relief (physiological measure 2 - heart rate)

    30 minutes

  • Anxiety relief (physiological measure 3 - respiratory rate)

    30 minutes

  • Postoperative CVICU Outcome 1 - Length of Stay

    Within 30 days after the patient is discharged from CVICU

  • Postoperative CVICU Outcome 2 - Intubation Time

    Within 30 days after the patient is discharged from CVICU

  • +2 more secondary outcomes

Study Arms (2)

Intervention - Visually Immersive Video Education

EXPERIMENTAL

Participants receive visually immersive (virtual reality-designed) preoperative video education shown on a tablet that orients patients to the postoperative CVICU environment, equipment, and expected recovery processes. After viewing the video, the open-heart trained CVICU nurse provides opportunity for discussion, clarification, and questions. Assignment to this arm occurs during intervention weeks (Weeks 1-2 of each month, per protocol).

Behavioral: Visually Immersive Video

Control - Standard Preoperative Education

ACTIVE COMPARATOR

Participants receive standard preoperative education consisting of a basic verbal explanation of what to expect postoperatively on arrival to the CVICU, followed by opportunity for questions. Assignment to this arm occurs during control weeks (Weeks 3-4 of each month, per protocol).

Behavioral: Standard of Care

Interventions

The patients watch a 5-minute visually immersive education video on what to expect postoperatively on arrival to the cardiovascular intensive care unit (CVICU) followed by the opportunity for discussion/explanation and questions.

Intervention - Visually Immersive Video Education

The patient receives a basic verbal explanation of what to expect postoperatively on arrival to CVICU followed by the opportunity for questions.

Control - Standard Preoperative Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients and outpatients scheduled for elective cardiothoracic (open heart) surgery

You may not qualify if:

  • Patients undergoing emergent cardiothoracic (open heart) surgery
  • Patients with altered mental status
  • History of mental health disorders (schizophrenia and bipolar disorder)
  • Legally blind/complete blindness and hearing impaired (without hearing aids)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Miami Hospital

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Natalie Bermudez, PhD, RN, EBP-C

    Baptist Health | Nursing & Health Sciences Research

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 30, 2025

Study Start

January 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Last Updated

March 4, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations