Total ThyroidectomyTiNeCoMNCT06909513
Impact of Travel Neck Pillow Use on Neck Comfort and Mobility After Thyroidectomy
A study testing U-shaped Travel Neck Pillow in people with Total Thyroidectomy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Thyroidectomy
- What is being tested?
- U-shaped Travel Neck Pillow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2024to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with a previously diagnosed condition in the cervical spine region prior to surgery
- Patients who have previously undergone thyroidectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- U-shaped Travel Neck Pillow
- Keywords
- Cervical comfort, Postoperative neck pain, Neck stiffness, U-shaped Travel neck pillow, Cervical mobility, Nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-shaped Travel Neck PillowDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The scale was filled in the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start5 Dec 2024
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total ThyroidectomyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali BAŞGÜN, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909513
- Sponsor's protocol ID
- 2024/271
- Other IDs
- 2024/271
- Acronym
- TiNeCoM
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Travel Neck Pillow Usage on Cervical Comfort, Pain,Stiff Neck and Cervical Range of Motion After Thyroidectomy
- ClinicalTrials.gov ID
- NCT06909513
- Acronym / sponsor ID
- TiNeCoM / 2024/271
- Conditions
- Total Thyroidectomy
- Keywords
- Cervical comfort, Postoperative neck pain, Neck stiffness, U-shaped Travel neck pillow, Cervical mobility, Nursing care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Dec 2025 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U-shaped Travel Neck Pillow | Experimental | Device: U-shaped Travel Neck PillowParticipants 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 | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with a previously diagnosed condition in the cervical spine region prior to surgery
- Patients who have previously undergone thyroidectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| U-shaped Travel Neck PillowAlso: Travel Neck PillowParticipants 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 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U-shaped Travel Neck Pillow in people with Total Thyroidectomy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Patient Comfort Using the Visual Analog Scale (VAS) (time frame: The scale was filled in the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.