Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy

NCT06823687 | Completed

• 1 other identifier: 2023/06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Nodule

Keywords

Thyroid Fine Needle Aspiration Biopsy

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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.

  Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)

Secondary Outcomes (3)

• Physiological Symptoms of Anxiety Follow-up Form

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

• Physiological Symptoms of Anxiety Follow-up Form

  Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)

• Virtual Reality Glasses Application Satisfaction Form

  Immediately after the intervention (Thyroid Fine Needle Aspiration Biopsy)

Study Arms (2)

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.

Other: Virtual reality glasses

Control grups

NO INTERVENTION

Routine maintenance will be applied

Interventions

Virtual reality glasses OTHER

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

Virtual reality glasses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Those with psychiatric problems
• Being unconscious

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38418943 RESULT

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zülfünaz Özer

  İstanbul Sabahattin Zaim Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is an experimental study with pre-test and post-test control groups

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 12, 2025
• Study Start: January 2, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)