NCT06127758

Brief Summary

Purpose and Type of Research:This study will be conducted to examine the effect of virtual reality glasses on surgical fear and anxiety in patients scheduled for cardiovascular surgery. The study is a randomized controlled experimental research. Method:The population of the research was approximately 2900 patients who underwent cardiovascular surgery in a year at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. The sample size of the study was calculated using the G\*Power software program.The study will be completed with 60 people by taking 30 people into the experimental and control groups.Data will be collected with a personal information form, surgical fear scale and state anxiety scale. Hypothesis of the Research: H1: Application of virtual reality glasses reduces surgical fear in patients planned for cardiovascular surgery. H2: Application of virtual reality glasses reduces anxiety in patients scheduled for cardiovascular surgery.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Status
unknown

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 Start

First participant enrolled

November 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 6, 2023

Last Update Submit

November 6, 2023

Conditions

Keywords

Heart surgerysurgical fearanxietyvirtual reality

Outcome Measures

Primary Outcomes (3)

  • Personal Information Form

    The form prepared by the researchers contains a total of 8 questions containing the patients' introductory information.

    for 1 day

  • surgical fear scale

    There are 8 questions in the scale. The scale is an 11-point Likert type scale with a score between 0 and 10. The scale included two subscales related to the source of fear, each consisting of 4 items. While items 1 to 4 on the scale measure the fear of the short-term consequences of surgery, items 5 to 8 measure the fear of the long-term consequences of surgery (0: not at all afraid, 10: very afraid). An increase in the score indicates an increase in fear.

    for 1 day

  • state anxiety scale

    It consists of a total of 40 items and is scored from 1 to 4. Scale items are evaluated using the "Likert type" scaling method as "1 = not at all", "2 = a little", "3 = a lot", "4 = completely". A high score on the scale indicates a high level of anxiety; A low score indicates a low level of anxiety. In the validity and reliability study of the scale, the alpha value was found to be 0.91.

    for 1 day

Study Arms (2)

VRG

EXPERIMENTAL
Other: virtual reality glasses applicationOther: classical training

control group

ACTIVE COMPARATOR
Other: classical training

Interventions

The experimental group will be given classical training (how to perform the surgery, complications that may occur after the surgery, preparation of fresh blood on the day of surgery, shaving by the barber on the morning of the surgery, how to take care of the mouth after shaving, how to shower with chlorexidine sponges, use of an apron, cap and mask after the shower). After 15 minutes video containing nature images and sounds will be shown through virtual glasses.

VRG

Information about classical training (how to perform the surgery, complications that may occur after the surgery, preparation of fresh blood on the day of surgery, shaving by the barber on the morning of the surgery, how to take care of the mouth after shaving, how to shower with chlorexidine sponges, use of an apron, cap and mask after the shower) will be given.

VRGcontrol group

Eligibility Criteria

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

You may qualify if:

  • years and over,
  • Those who will undergo open heart surgery,
  • Those who have not had cardiovascular surgery before,
  • No communication problems,
  • Is conscious and able to answer questions and does not have any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
  • Does not have a psychiatric disease such as anxiety disorder, panic attack, depression,
  • Individuals who do not receive psychiatric treatment such as antipsychotics/anxiolytics will be included in the study.

You may not qualify if:

  • Being under the age of 18,
  • Not having open heart surgery,
  • Those who have previously undergone cardiovascular surgery,
  • Having communication problems,
  • Those who are unconscious and unable to answer questions Having any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
  • Having a psychiatric disease such as anxiety disorder, panic attack, depression,
  • Individuals receiving psychiatric treatment such as antipsychotic/anxiolytic will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
postgraduate student

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 13, 2023

Study Start

November 1, 2023

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share