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Recruiting NCT07266987

Multisensory Methods and Patient Comfort in Thyroid Biopsy

No phase Interventional Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MULTİSENSORY Video.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Interventions

  • Other 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.

Primary outcome measures

  • The patient's pain level [Time frame: 5 month]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Muş State Hospital — Muş

Identifiers

NCT: NCT07266987 · muş alpa

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗