NCT06458647

Brief Summary

This study was planned as a randomized controlled experimental study to examine the effects of virtual reality video on anxiety, comfort and patient satisfaction before coronary angiography. Data will be collected using the Descriptive Characteristics Questionnaire, State-Trait Anxiety Inventory, Early Postoperative Comfort Scale, Visual Analog Scale (VAS) for patient satisfaction and pain, Vital Signs Follow-up Form and Complication Follow-up Form.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable anxiety

Status
not yet recruiting

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 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 9, 2024

Last Update Submit

June 9, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Anxiety

    This inventory, which consists of a total of 40 items, is analyzed in two separate sections: The first part is the State Anxiety Inventory, which consists of 20 items, and the individual answers this section with his/her current feelings. The second part is the Trait Anxiety Inventory, which also consists of 20 items, and the individual answers this section with the feelings they have felt in the last 7 days.

    30 minutes after angiography

  • Comfort

    The scale, which is based on the concept of comfort, consists of a total of 24 items, 12 of which question the comfort status of the individual before and after the surgical intervention, 12 of which question positive and 12 of which question negative experiences.

    30 minutes after angiography

  • Patient satisfaction

    Patients will be asked to rate their satisfaction with the intervention on a 10-point scale.

    30 minutes after angiography

Study Arms (2)

Intervention group

EXPERIMENTAL

Individuals in the intervention group will be shown a video with virtual reality glasses before entering the angiography procedure.

Other: Video Streaming with Virtual Reality

Control group

NO INTERVENTION

No application will be made to the control group before the procedure.

Interventions

In the study, patients in the intervention group will be watched videos of natural landscapes such as mountains, beaches and waterfalls with virtual reality goggles before the angiography procedure.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Can speak and understand Turkish,
  • Over 18 years of age,
  • No previous angiography procedure,
  • Oriented to place and time,
  • No psychiatric illness,
  • Not taking any sedative medication,
  • No vision and hearing problems,
  • Patients who volunteered to participate in the study will be included.

You may not qualify if:

  • Patients with any pain or chronic pain prior to coronary angiography,
  • Patients diagnosed with anxiety,
  • Patients with pacemakers,
  • Patients requiring emergency angiography,
  • Patients taking antihistamines and psychiatric drugs,
  • Patients who did not volunteer to participate in the study,
  • Patients taking tranquilizers or pain medication up to 5 hours before the angiography procedure were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersPatient Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof.

Study Record Dates

First Submitted

June 9, 2024

First Posted

June 13, 2024

Study Start

July 1, 2024

Primary Completion

October 15, 2024

Study Completion

December 15, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share