Impact of Travel Neck Pillow Use on Neck Comfort and Mobility After Thyroidectomy (TiNeCoM)

March 27, 2025 updated by: Ali BAŞGÜN, TC Erciyes University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Talas
      • Kayseri, Talas, Turkey, 38280
        • Erciyes Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with a previously diagnosed condition in the cervical spine region prior to surgery

Patients who have previously undergone thyroidectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: U-shaped Travel Neck Pillow
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.
Device: U-shaped Travel Neck Pillow
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.
Other Names:
  • Travel Neck Pillow
No Intervention: Routine Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Patient Comfort Using the Visual Analog Scale (VAS)
Time Frame: 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.
The scale was filled in the baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Pain Using the Visual Analog Scale (VAS)
Time Frame: The scale was filled in the baseline
The Visual Analog Scale (VAS) is a 10 cm line, drawn either horizontally or vertically, with one end labeled "no pain" and the other end labeled "worst imaginable pain." Participants are asked to mark the point on the line that best represents their level of pain. In this study, the horizontal format will be used, as it has been reported to be more reliable.
The scale was filled in the baseline
McGill Pain Questionnaire
Time Frame: The scale was filled in the baseline
The McGill Pain Questionnaire (MPQ) was developed by Melzack and Torgerson in 1971 and validated in Turkish by Kuğuoğlu, Eti Aslan, and Olgun in 2003. It consists of four parts: (1) Participants indicate the pain location on a body diagram and specify whether the pain is deep (D), surface-level (Y), or both (D-Y). (2) They select descriptive words from 20 word groups that reflect the sensory, affective, and evaluative qualities of their pain. (3) The form includes items that evaluate the temporal characteristics of pain and factors that increase or reduce it. (4) Pain intensity is rated using five levels from mild to unbearable. Each response has a point value, and total scores range from 0 to 112. Higher scores indicate more severe pain.
The scale was filled in the baseline
Cervical Spine Range of Motion Assessment
Time Frame: The scale was filled in the baseline
Cervical spine range of motion will be assessed using a universal goniometer, a simple protractor-like tool designed to measure joint angles. The evaluation will follow the Kendall-McCreary criteria, which define normal cervical motion as 45-65° for flexion, 45-50° for extension, 55° for rotation, and 40° for lateral flexion. To avoid compromising the surgical incision, extension will not be performed in this study. Measurements will focus on flexion, rotation, and lateral flexion.
The scale was filled in the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Estimated)

June 5, 2025

Study Completion (Estimated)

December 5, 2025

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024/271 (Other Identifier: Erciyes Üniversitesi)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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