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

NCT06909513 | Enrolling By Invitation

• 1 other identifier: 2024/271
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Thyroidectomy

Keywords

Cervical comfort; Postoperative neck pain; Neck stiffness; U-shaped Travel neck pillow; Cervical mobility; Nursing care

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• Assessment of Pain Using the Visual Analog Scale (VAS)

  The scale was filled in the baseline

• McGill Pain Questionnaire

  The scale was filled in the baseline

• Cervical Spine Range of Motion Assessment

  The scale was filled in the baseline

Study Arms (2)

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.

Device: U-shaped Travel Neck Pillow

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.

Interventions

U-shaped Travel Neck Pillow DEVICE

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.

Also known as: Travel Neck Pillow

U-shaped Travel Neck Pillow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Üniversitesi

Kayseri, Talas, 38280, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ali BAŞGÜN, MSc, Principal Investigator

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: December 5, 2024
• Primary Completion: June 5, 2025
• Study Completion: December 5, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

TU (1)