跳至主要内容
临床试验/NCT06909513
NCT06909513Enrolling By Invitation不适用

Effects of Travel Neck Pillow Usage on Cervical Comfort, Pain,Stiff Neck and Cervical Range of Motion After Thyroidectomy

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
110
试验地点
1
主要终点
Assessment of Patient Comfort Using the Visual Analog Scale (VAS)

研究概览

简要总结

This study aims to evaluate the effectiveness of U-shaped travel neck pillow use in improving cervical comfort, reducing neck pain and stiffness, and enhancing cervical range of motion in adults undergoing total thyroidectomy surgery. It is the first randomized controlled trial in Turkey to examine the use of a travel neck pillow as a non-pharmacological intervention during the immediate postoperative period (day 0).

The study will be conducted at Erciyes University Gevher Nesibe Hospital between December 5, 2024 and June 5, 2025. Participants will be randomly assigned to either the pillow group or the control group. Those in the pillow group will use a U-shaped neck pillow for the first 24 hours after surgery while at rest.

Outcomes will be assessed using the Visual Analog Scale (VAS) for pain and comfort, the McGill Pain Questionnaire for pain localization and intensity, and goniometric measurements of cervical range of motion. Data will be collected preoperatively and at 24 hours postoperatively.

This study is expected to provide clinical evidence supporting the use of travel neck pillows to improve postoperative comfort and mobility, offering a simple and cost-effective nursing intervention for thyroidectomy recovery.

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
None

入排标准

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

入选标准

  • •Scheduled to undergo elective total thyroidectomy
  • •Classified as ASA physical status I or II
  • •Aged 18 years or older
  • •No communication impairments
  • •Willing to participate and provide informed consent

排除标准

  • •Patients with a previously diagnosed condition in the cervical spine region prior to surgery
  • •Patients who have previously undergone thyroidectomy

研究组 & 干预措施

U-shaped Travel Neck Pillow

Experimental

Participants in the intervention group will receive a U-shaped travel neck pillow immediately after surgery upon arrival to the ward. The pillow will be used only during rest (supine or semi-Fowler's position) for the first 24 hours postoperatively and removed before mobilization begins. After removal, assessments will include cervical comfort using the Visual Analog Scale (VAS), pain scores during neck movements (flexion, rotation, lateral flexion-excluding extension) via VAS, the McGill Pain Questionnaire for pain localization and severity, and cervical range of motion using a universal goniometer. This intervention aims to evaluate the pillow's effectiveness in reducing neck pain, stiffness, and discomfort, and improving mobility after thyroidectomy.

干预措施: U-shaped Travel Neck Pillow (Device)

Routine Care

No Intervention

Participants in the control group will receive standard postoperative care following total thyroidectomy, without the use of a neck pillow. No additional non-pharmacological interventions will be provided. Pain management, mobilization, and other postoperative procedures will follow the hospital's routine clinical protocol. At 24 hours postoperatively, participants will be assessed for cervical comfort using the Visual Analog Scale (VAS), neck pain during movements (excluding extension) using VAS, pain localization and severity via the McGill Pain Questionnaire, and cervical range of motion using a universal goniometer. This group serves as a comparison to evaluate the effectiveness of the neck pillow intervention.

结局指标

主要结局

Assessment of Patient Comfort Using the Visual Analog Scale (VAS)

时间窗: The scale was filled in the baseline

The Visual Analog Scale (VAS) is used to measure patient comfort. It is a 10 cm (100 mm) long line that can be oriented either horizontally or vertically. On this scale, 0 indicates "extremely uncomfortable" and 100 indicates "completely comfortable." In this study, the 10 cm VAS will be used in a horizontal orientation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali BAŞGÜN

Ali BAŞGÜN, MSc, Principal Investigator

TC Erciyes University

研究点 (1)

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