Multisensory Methods and Patient Comfort in Thyroid Biopsy

Официальное название

The Effect ofMultisensory Methods on Pain, Anxiety, and Comfort Levels in Patients Undergoing Thyroid Biopsy

Обзор

This quasi-experimental study aims to determine the effect of watching an therapeutic video on patients' pain, anxiety, and comfort levels during thyroid biopsy procedures. The study will be conducted in the interventional radiology unit of Muş State Hospital between July 30, 2025, and August 28, 2026. A total of 68 patients (34 experimental and 34 control) will be included. Data will be collected using the Descriptive Information Form, Visual Analog Scale for Pain (VAS-Pain), State Anxiety Inventory, and Visual Analog Scale for Comfort (VAS-Comfort). The intervention group will watch a relaxing video immediately before and during the biopsy procedure, while the control group will receive standard care. Pre- and post-test measurements will be compared to evaluate changes in pain, anxiety, and comfort levels

Подробное описание

This study is designed as a quasi-experimental, pretest-posttest controlled intervention trial. The study will be conducted in the interventional radiology unit of Muş State Hospital, Türkiye. The target population consists of patients scheduled for thyroid (goiter) biopsy. Sample size was determined using G\*Power software (version 3.1.9.7) based on a medium effect size (d = 0.5), α = 0.05, and statistical power of 0.80, resulting in a total sample of 68 participants (34 intervention and 34 control).

Participants will be assigned to groups using an alternating allocation method. Patients with even numbers will be allocated to the intervention group, and those with odd numbers to the control group. The intervention group will receive a multisensory relaxation intervention consisting of a therapeutic audiovisual (relaxing nature-based) video displayed immediately before and during the biopsy procedure. The aim of the intervention is to reduce procedural anxiety and discomfort. The control group will receive standard routine care without any additional intervention.

Eligibility criteria include being literate and free from diagnosed psychiatric disorders. Exclusion criteria include the presence of psychiatric or neurological conditions that may affect response reliability (e.g., bipolar disorder, dementia) and previous experience of thyroid biopsy.

Data will be collected using standardized instruments, including a researcher-developed demographic and clinical information form, a Visual Analog Scale for pain assessment (VAS-Pain; 0-10 scale), the State Anxiety Inventory for measuring situational anxiety, and a Visual Analog Scale for comfort (VAS-Comfort; 0-10 scale). These instruments will be used to evaluate psychological and procedural outcomes associated with the intervention.

Вмешательства

• Другое MULTİSENSORY Video
  The multisensory video is a short therapeutic and relaxing video designed to stimulate multiple senses-sight and hearing-simultaneously. It includes calming nature scenes, soft background music, and soothing narration to create a relaxing environment. The purpose of the multisensory video is to reduce anxiety, distract attention from the invasive procedure, and enhance patient comfort during the thyroid biopsy.

Первичные конечные точки

• The patient's pain level [Срок оценки: 5 month]

Критерии участия

Критерии включения

Literate individuals who can read and write Aged 18 years and older Scheduled to undergo thyroid (goiter) biopsy in the interventional radiology unit Voluntarily agreeing to participate in the study and providing informed consent No diagnosed psychiatric or cognitive impairment that may affect participation

Критерии исключения

Presence of a diagnosed psychiatric disorder that may affect response reliability (e.g., bipolar disorder, dementia, schizophrenia) Previous history of thyroid biopsy Visual or hearing impairments that prevent viewing or understanding the intervention video Refusal to participate or withdrawal of consent at any stage of the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Muş State Hospital — Muş

Идентификаторы

NCT: NCT07266987 · muş alpa

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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