NCT07032935

Brief Summary

Virtual reality (VR) glasses are an effective non-pharmacological method for reducing anxiety, supported by a high level of evidence and associated with no known side effects. Techniques involving relaxation and distraction, such as VR, function by suppressing the sympathetic branch of the autonomic nervous system and activating the parasympathetic branch, thereby eliciting a relaxation response. VR glasses divert the patient's attention away from pain and anxiety. By reducing the sense of unfamiliarity in clinical environments, VR helps patients adapt more easily, leading to enhanced relaxation. This state of relaxation not only alleviates anxiety but also induces favorable physiological responses. These include reductions in blood pressure (BP), heart rate (HR), and respiratory rate (RR), along with an increase in peripheral oxygen saturation (SpO₂). Additionally, the psychological benefits of VR contribute to the reduction of anxiety, stress, fear, and worry. VR is considered a cost-effective, safe, and non-pharmacological intervention. Several studies support its efficacy. For example, in a study comparing the effects of video games played through VR headsets and iPads on preoperative anxiety in adult patients undergoing sternotomy, anxiety was measured using the Depression Anxiety Stress Scale (DASS), and lower anxiety levels were observed in the VR group. Another study demonstrated that watching nature scenes through VR glasses for five minutes prior to maxillofacial surgery significantly reduced anxiety. Furthermore, research comparing progressive muscle relaxation exercises and VR during arthroscopic knee surgery-measured using the State Anxiety Inventory-indicated that both non-pharmacological interventions were effective in reducing anxiety. However, despite this growing body of evidence, no study to date has examined the effects of VR applications on anxiety in patients undergoing coronary angiography or pacemaker implantation. This study aims to fill that gap by investigating the comparative effectiveness of virtual reality applications in reducing anxiety in patients undergoing coronary angiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

September 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

June 11, 2025

Last Update Submit

August 26, 2025

Conditions

Keywords

coronary angiographyvirtual reality glassesanxietyvital signs

Outcome Measures

Primary Outcomes (1)

  • Change in State Anxiety Score

    Before and after the intervention (pre- and post-intervention) It will be measured using the State Anxiety Inventory (STAI-I). The score varies between 20 and 80.

    Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed

Secondary Outcomes (3)

  • Change in Vital Signs (Heart Rate)

    Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed

  • Change in Vital Signs (Blood Pressure)

    Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed

  • Change in Vital Signs (Respiratory Rate)

    Before the intervention (15 minutes before the procedure), and within the first 15 minutes after the intervention is completed

Study Arms (2)

Control Group

NO INTERVENTION

No intervention will be made to the patient during the Coronary Angiography application.

virtual reality glasses Group

EXPERIMENTAL
Behavioral: Virtual Reality Glasses will be used DURING CORONARY ANGIOGRAPHY APPLICATION

Interventions

Virtual Reality Glasses will be used DURING CORONARY ANGIOGRAPHY APPLICATION

virtual reality glasses Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are over 18 years of age,
  • Do not have any psychiatric illness,
  • Do not have any vision, hearing or perception problems,
  • Are at least a primary school graduate,
  • Do not have any disorder/disease affecting decision-making ability (dementia, psychological disorder, etc.)
  • Volunteer to participate in the study,
  • Are open to communication and cooperation.

You may not qualify if:

  • Patients who receive sedation, patients who cannot communicate, patients with visual or hearing impairments, and individuals who do not agree to participate in the research will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Merkez, Kütahya, 43200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: virtual reality glasses
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 24, 2025

Study Start

July 15, 2025

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

September 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations