Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy
February 8, 2025 updated by: Zülfünaz ÖZER, Istanbul Sabahattin Zaim University
The Effect of Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy on Anxiety Level, Pain Intensity and Patient Satisfaction
The Effect of Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy on Anxiety Level, Pain Intensity and Patient Satisfaction
Study Overview
Detailed Description
Beginning 1-2 minute before the start of the procedure, the patients will be watched (5-10 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Küçükçekmece
-
Istanbul, Küçükçekmece, Turkey, 34303
- Istanbul Sabahattin Zaim University, Faculty of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being over 18 years old
- Ability to communicate adequately
- Volunteering to participate in the research
Exclusion Criteria:
- Those with psychiatric problems
- Being unconscious
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality glasses
Virtual reality glasses Beginning 1-2 minute before the start of the procedure, the patients will be watched (5-10 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product.
|
Virtual reality glasses Beginning 1-2 minute before the start of the procedure, the patients will be watched (5-10 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses, with a music background, licensed product.
Other Names:
|
|
No Intervention: Control grups
Routine maintenance will be applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
|
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line.
In addition, there were forms which were numbered from 1-10 or from 1-100.
The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line.
A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain.
VAS is a common scale in the assessment of pain level.
A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
|
Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
|
|
Visual Analog Scale
Time Frame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
|
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line.
In addition, there were forms which were numbered from 1-10 or from 1-100.
The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line.
A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain.
VAS is a common scale in the assessment of pain level.
A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
|
Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
|
|
State-trait anxiety inventory (STAI FORM TX-1)
Time Frame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
|
State anxiety refers to transient emotional reactions manifested by the individual to on constant situations with varying intensity depending on the situation.
In situations where the individual perceives the stressful situation as a threat, the level of "state anxiety" is high and in situations where this danger is not perceived as threatening, the level of state anxiety is low.
The state anxiety inventory requires the individual to describe how they feel at a given moment and under certain circumstances, taking into account their feelings about the situation in which they are in.
It measures the state of the individual, that is, the level of anxiety in which they are currently in.
The intensity of the instantaneous stress, anxiety, and excitement responses caused by conditions increases or decreases over time.
Individuals respond to the items on the inventory based on the degree of severity of their emotions at the moment.
|
Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
|
|
State-trait anxiety inventory (STAI FORM TX-1)
Time Frame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
|
State anxiety refers to transient emotional reactions manifested by the individual to on constant situations with varying intensity depending on the situation.
In situations where the individual perceives the stressful situation as a threat, the level of "state anxiety" is high and in situations where this danger is not perceived as threatening, the level of state anxiety is low.
The state anxiety inventory requires the individual to describe how they feel at a given moment and under certain circumstances, taking into account their feelings about the situation in which they are in.
It measures the state of the individual, that is, the level of anxiety in which they are currently in.
The intensity of the instantaneous stress, anxiety, and excitement responses caused by conditions increases or decreases over time.
Individuals respond to the items on the inventory based on the degree of severity of their emotions at the moment.
|
Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physiological Symptoms of Anxiety Follow-up Form
Time Frame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
|
This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.
|
Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
|
|
Physiological Symptoms of Anxiety Follow-up Form
Time Frame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
|
This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.
|
Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
|
|
Virtual Reality Glasses Application Satisfaction Form
Time Frame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
|
In this form, there are questions prepared in line with the relevant literature in order to determine the satisfaction with the video watched with virtual reality glasses.
|
Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zülfünaz Özer, İstanbul Sabahattin Zaim Üniversitesi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2024
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
April 30, 2024
Study Registration Dates
First Submitted
February 2, 2025
First Submitted That Met QC Criteria
February 8, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 8, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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