The Effect of Virtual Reality Applications

NCT06792929 | Not Yet Recruiting

• 1 other identifier: DICLE-ARDASURUCU-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Thyroid nodules are a common health problem in the adult population. The majority of cancers are diagnosed by thyroid fine needle aspiration biopsy. Thyroid nodules generally show clinical findings in 1-5% of cases on physical examination and 20-70% on ultrasound examination. In diagnosis; Ultrasonography, fine needle aspiration biopsy, ultrasonography-guided fine needle aspiration biopsy, scintigraphy, computed tomography and magnetic resonance imaging are widely used. The fact that the thyroid fine needle aspiration biopsy procedure is painful, there is no speaking or coughing during the procedure, and in case of insufficient sample, the procedure must be performed several times. Its repetition causes fear and anxiety in patients. A combination of pharmacological and nonpharmacological methods for pain control likely provides the most effective pain relief for the patient. Distraction is one of the non-pharmacological methods used in pain control. Distraction is one of the most preferred methods to reduce pain in patients during diagnosis and treatment procedures. It is a method that allows patients to control and reduce the symptoms they experience by focusing their attention on a different point.The aim of this study is to examine the effect of using a motivational video with virtual reality glasses to distract attention during the biopsy procedure on pain, stress and fear in individuals with suspected thyroid cancer.

Conditions

Thyroid Cancer; Virtual Reality Therapy; Ultrasound; Fine Needle Aspiration Biopsy; Thyroid Nodule (Diagnosis)

Keywords

Thyroid Cancer; Virtual Reality Therapy; Ultrasound; Thyroid Nodule; Fine needle aspiration biopsy

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  The scale is used to assess subjectively perceived pain. It is a 10 cm (100 mm) ruler with no pain on one end and the "most severe pain" on the other. The individuals participating in the study are asked to mark the intensity of pain they are currently feeling, explaining that the number "0" on the scale means "I feel no pain" and that the intensity of pain increases as the numbers increase, and the number "10" means "I feel the most severe pain". An increase in the score obtained from the scale in the assessment indicates that the pain is increasing. Each patient will be administered two times.

  Before and immediately after ultrasound guided fine needle aspiration biopsy procedure

Secondary Outcomes (2)

• Fear of Pain Scale-III

  Before and immediately after ultrasound guided fine needle aspiration biopsy procedure

• Beck Anxiety Scale

  Before and immediately after ultrasound guided fine needle aspiration biopsy procedure

Study Arms (2)

virtual reality glasses group

EXPERIMENTAL

Patients will wear virtual reality glasses throughout the ultrasound-guided fine needle aspiration biopsy procedure.

Device: virtual reality glasses group

Control group

NO INTERVENTION

patients without of virtual reality glasses

Interventions

virtual reality glasses group DEVICE

Patients will wear virtual reality glasses throughout the ultrasound-guided fine needle aspiration biopsy procedure.

virtual reality glasses group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected thyroid mass
• No dizziness problem
• No vision problems

You may not qualify if:

• Mental health problems that may prevent wearing virtual reality glasses

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle Univertsity

Diyarbakır, South East, 21100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule; Disease

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: They do not know the experimental or control procedures that take place
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: virtual reality glasses group and control group

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 27, 2025
• Study Start: February 25, 2025
• Primary Completion: April 30, 2025
• Study Completion: August 30, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)