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

NCT ID: NCT06909513

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-05
• Study Completion Date: 2025-12-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

U-shaped Travel Neck Pillow

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Travel Neck Pillow

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Ali BAŞGÜN

Ali BAŞGÜN, MSc, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erciyes Üniversitesi

Kayseri, Talas, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024/271

Identifier Type: OTHER

Identifier Source: secondary_id

2024/271

Identifier Type: -

Identifier Source: org_study_id