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临床试验/NCT07259551
NCT07259551已完成不适用

Effect of the Palming Technique on Preoperative Anxiety and Hemodynamic Responses in Thyroid Surgery

Yuzuncu Yil University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Change in Preoperative Anxiety Score (State-Trait Anxiety Inventory - STAI-State)

研究概览

简要总结

Purpose of the Observational Study: The purpose of this observational study was to evaluate the effects of the palmar technique on preoperative anxiety, hemodynamic parameters, and intubation-related hemodynamic responses in patients undergoing thyroidectomy.

Primary Research Question: Does the palmar technique applied preoperatively reduce preoperative anxiety and associated hemodynamic changes in thyroidectomy patients? Study Design: Type: Prospective, single-blind, observational study Location: A single-center tertiary care hospital in Turkey Sample: 80 patients aged 18-65, ASA I-II

Methods:

Patients were divided into two groups using a sealed envelope method:

Group P: Patients who received the palm-based technique Group N: Control group without intervention

When admitted to the preoperative waiting room (T1), all patients:

Baseline vital signs (SpO₂, heart rate, blood pressure) State-Trait Anxiety Inventory (STAI) scores were recorded. Patients in Group P received the palm-based technique; Group N received no intervention.

The same parameters were measured again 15 minutes later (T2).

After transfer to the operating room, standard monitoring was performed, and hemodynamic data were recorded at the following times:

Pre-intubation (T3)

1 min (T4), 3 min (T5), 5 min (T6), and 10 min (T7) after intubation Main Outcome Measures: Changes in preoperative anxiety level Changes in hemodynamic parameters after the palmar technique Sample Size:Total: 80 patients

详细描述

Purpose of the Observational Study: The purpose of this observational study was to evaluate the effects of the palmar technique on preoperative anxiety, hemodynamic parameters, and intubation-related hemodynamic responses in patients undergoing thyroidectomy.

Primary Research Question: Does the palmar technique applied preoperatively reduce preoperative anxiety and associated hemodynamic changes in thyroidectomy patients? Study Design: Type: Prospective, single-blind, observational study Location: A single-center tertiary care hospital in Turkey Sample: 80 patients aged 18-65, ASA I-II

Methods:

Patients were divided into two groups using a sealed envelope method:

Group P: Patients who received the palm-based technique Group N: Control group without intervention

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-65 years
  • Patients classified as ASA I-II
  • Patients scheduled for thyroid surgery
  • Patients without a history of glaucoma
  • Patients without active psychiatric or neurological disease
  • Patients who were informed about the study and provided written informed consent

排除标准

  • Patients with a diagnosed psychiatric disorder
  • Patients using sedatives, antidepressants, or antiepileptic medications
  • Patients with impaired cooperation, comprehension, vision, or hearing
  • Patients with a history of ophthalmic surgery
  • Patients classified as ASA III or higher

结局指标

主要结局

Change in Preoperative Anxiety Score (State-Trait Anxiety Inventory - STAI-State)

时间窗: Baseline (T1) and 15 minutes after intervention (T2)

Baseline (TPreoperative anxiety will be assessed using the State-Trait Anxiety Inventory - State (STAI-State) scale (range: 20-80; higher scores indicate higher anxiety). The primary outcome is the change in STAI-State score from baseline (T1) to 15 minutes after the palming technique (T2).1) and 15 minutes after intervention (T2)

Change in Heart Rate

时间窗: Baseline (T1) and 15 minutes after intervention (T2)

Change in heart rate (beats per minute) between baseline (T1) and 15 minutes after the palming technique (T2).

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yil University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nureddin YUZKAT

Associate professor

Yuzuncu Yil University

研究点 (1)

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