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NCT Number: NCT06792929

The Effect of Virtual Reality Applications

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dicle Univertsity

Diyarbakır, South East, 21100, Turkey (Türkiye)

About this study

Research Type:

It was designed as a randomized controlled experimental study.

Research Population and Sample:

The research sample will consist of patients with suspected thyroid mass who applied to a University Hospitals. The sample of the research is aimed to be 100 volunteer diabetic patients who applied to the University Hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Mental health problems that may prevent wearing virtual reality glasses

Treatment and study plan

virtual reality glasses group

Device

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

Primary outcomes

  1. Visual Analogue Scale

    Time frame: Before and immediately after ultrasound guided fine needle aspiration biopsy procedure

    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.

Secondary outcomes

  1. Fear of Pain Scale-III

    Time frame: Before and immediately after ultrasound guided fine needle aspiration biopsy procedure

    Fear of Pain Scale-III is a 30-item, 5-point Likert type scale developed to measure fear and/or anxiety about pain. The scale consists of 3 sub-dimensions and there are 10 items in each dimension. Scale items for fear of severe pain are 1, 3, 5, 6, 9, 10, 13, 18, 25, 27; scale items for fear of mild pain 2, 4, 7, 12, 19, 22, 23, 24, 28, 30; The scale items for fear of medical pain are 8, 11, 14, 15, 16, 17, 20, 21, 26, 29. In evaluating the score of the scale, which has no inverse expression, the items are rated with a Likert-type scoring ranging from 1 to 5 (1- never, 2-a little, 3-quite a bit, 4-a lot, 5-extremely). 1-refers to never feeling fear, 5-expresses excessive fear. The lowest possible score in total is 30 and the highest score is 150. The lowest score that can be obtained for the sub-dimensions is 10 and the highest score is 50. A high score on the scale indicates that the individual's fear of pain is also high.

  2. Beck Anxiety Scale

    Time frame: Before and immediately after ultrasound guided fine needle aspiration biopsy procedure

    It measures the severity of anxiety symptoms experienced by individuals. Consisting of 21 items, scored between 0-3; It is a scale filled by the patient himself. Score Range is 0-63. Anxiety levels of the patients according to the scores obtained; 0-7 points are classified as no anxiety, 8-15 points as mild anxiety, 16-25 points as moderate anxiety, and 26 and above points as severe anxiety.

Sponsors and collaborators

Lead sponsor

Dicle University

Other

Registry information

Official study title

The Effect of Virtual Reality Applications on Diagnostic Procedures Performed in Patients With Suspicious Thyroid Cancer

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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