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CompletedNCT06823687Updated Feb 12, 2025

Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy

An interventional study of Virtual reality glasses in Thyroid Nodule, sponsored by Istanbul Sabahattin Zaim University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Istanbul Sabahattin Zaim University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2024, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The Effect of Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy on Anxiety Level, Pain Intensity and Patient Satisfaction

Read the 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.

02

Conditions studied

  • Thyroid Nodule

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Keywords

  • Thyroid Fine Needle Aspiration Biopsy
03

In context

Thyroid Nodule

203 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 120 interventional studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

Istanbul Sabahattin Zaim University is the lead sponsor of 26 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being over 18 years old
  • Ability to communicate adequately
  • Volunteering to participate in the research

Exclusion criteria

Exclusion Criteria:

  • Those with psychiatric problems
  • Being unconscious
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • 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.

    Other: Virtual reality glasses

  • No intervention
    Control grups

    Routine maintenance will be applied

Interventions

  • OtherVirtual 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.

    Also known as: Control group

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale

    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

    Time frame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)

  2. Visual Analog Scale

    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

    Time frame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)

  3. State-trait anxiety inventory (STAI FORM TX-1)

    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.

    Time frame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)

  4. State-trait anxiety inventory (STAI FORM TX-1)

    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.

    Time frame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)

Secondary outcomes

  1. Physiological Symptoms of Anxiety Follow-up Form

    This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.

    Time frame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)

  2. Physiological Symptoms of Anxiety Follow-up Form

    This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation (SpO2) value.

    Time frame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)

  3. Virtual Reality Glasses Application Satisfaction Form

    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.

    Time frame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)

07

Study locations

1 site
  • Istanbul Sabahattin Zaim University, Faculty of Health Sciences
    Istanbul, Küçükçekmece 34303, Turkey (Türkiye)
08

References and documents

Publications

  • Toraman RL, Eskici Ilgin V. Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction During a Transrectal Prostate Biopsy: A Randomized Controlled Trial. Biol Res Nurs. 2024 Oct;26(4):485-497. doi: 10.1177/10998004241236154. Epub 2024 Feb 28. PubMed 38418943 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Apr 2024, 3 months.

Of 62 non-industry interventional studies with no phase under Thyroid Nodule, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 3 months is below that.

Counting every sponsor, half of 65 studies reached it within 29 months; a quarter within 13 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2025
First posted
Feb 12, 2025
StartActual
Jan 2, 2024
Primary completionActual
Apr 30, 2024
CompletionActual
Apr 30, 2024
Last update
Feb 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06823687
Lead sponsor
Istanbul Sabahattin Zaim University
Responsible party
Zülfünaz ÖZER (Principal Investigator, Istanbul Sabahattin Zaim University) — Principal investigator
First posted
Feb 12, 2025
Start date
Jan 2, 2024
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024
Last update
Feb 12, 2025

Study contacts

Zülfünaz Özer
principal investigator · İstanbul Sabahattin Zaim Üniversitesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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