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临床试验/NCT07266987
NCT07266987招募中不适用

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

Muş Alparslan University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年7月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
68
试验地点
2
主要终点
The patient's pain level

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The data analyst was blinded to group allocation during the statistical analysis to prevent potential bias. Participant data were coded numerically, and the analyst did not have access to information identifying which participants belonged to the intervention or control group until the analysis was completed.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

experimental group

Experimental

干预措施: MULTİSENSORY Video (Other)

Control Group

No Intervention

结局指标

主要结局

The patient's pain level

时间窗: 5 month

Visual Analog Scale for Pain (VAS-Pain): Developed by Freyd (1983) to measure pain intensity on a 10-cm scale (0 = no pain, 10 = worst pain).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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