Thyroid NoduleNCT06823687
Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy
A study testing Virtual reality glasses in people with Thyroid Nodule, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy on Anxiety Level, Pain Intensity and Patient Satisfaction Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Ability to communicate adequately
- Volunteering to participate in the research
Who cannot join
- Those with psychiatric problems
- Being unconscious
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Sabahattin Zaim University, Faculty of Health Sciences
Istanbul, Küçükçekmece, 34303
About this study
Official title: 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
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.
- Conditions
- Thyroid Nodule
- Being tested
- Virtual reality glasses
- Keywords
- Thyroid Fine Needle Aspiration Biopsy
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glassesOther
Also called Control group
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses | Experimental | 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. Receives: Other: Virtual reality glasses |
| Control grups | No intervention | Routine maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
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
Measured: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
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.
Measured: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
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.
Measured: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
Secondary outcomes (3)
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.
Measured: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)
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.
Measured: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
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.
Measured: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start2 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is an experimental study with pre-test and post-test control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülfünaz ÖZER, Istanbul Sabahattin Zaim University
- Investigators
- Zülfünaz Özer, Principal investigator, İstanbul Sabahattin Zaim Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823687
- Sponsor's protocol ID
- 2023/06
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy on Anxiety Level, Pain Intensity and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT06823687
- Acronym / sponsor ID
- 2023/06
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid Fine Needle Aspiration Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Effect of Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy on Anxiety Level, Pain Intensity and Patient Satisfaction
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an experimental study with pre-test and post-test control groups
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses | Experimental | Other: Virtual reality glassesVirtual 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. |
| Control grups | No intervention | –Routine maintenance will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over 18 years old
- Ability to communicate adequately
- Volunteering to participate in the research
Key exclusion criteria (2 listed)
- Those with psychiatric problems
- Being unconscious
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality glassesAlso: Control groupVirtual 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 |
Primary outcome
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
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
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.
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.
3 secondary outcomes
Physiological Symptoms of Anxiety Follow-up Form
Time frame: 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)
Virtual Reality Glasses Application Satisfaction Form
Time frame: Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Results publication: PubMed 38418943Toraman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zülfünaz Özer principal investigator
İstanbul Sabahattin Zaim Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality glasses in people with Thyroid Nodule, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline, pre-intervention (Before Thyroid Fine Needle Aspiration Biopsy)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06823687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.