Swallowing DifficultiesCWS-THYNCT07879404
Effect of Cold Water Spray on Swallowing Difficulty, Pain, and Thirst After Thyroid Surgery
A study testing Cold water spray in people with Swallowing Difficulties and Thirst, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
Dysphagia and thirst are common in the early period after thyroidectomy and negatively affect patient comfort. This study aims to evaluate the effect of cold water spray on dysphagia, pain during swallowing, and thirst after thyroid surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Difficulties, Thirst, Thyroidectomy
- What is being tested?
- Cold water spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2026to 30 Aug 2027
- 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
- Having undergone thyroid surgery
- ASA physical status classification I-II
Who cannot join
- Impaired integrity of the oral and tongue mucosa in the preoperative period
- Having an oral or nasal disease
- Having visual, hearing, speech, or comprehension impairment
- Having diabetes mellitus
- Having a diagnosis of xerostomia (dry mouth)
- Having hypercalcemia
- Having hypokalemia
- Regular preoperative use of antidepressants or anticholinergic (antimuscarinic) medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Gülhane Hemşirelik Fakültesi
Ankara, Ankara
About this study
Official title: Effect of Cold Water Spray on Swallowing Difficulty, Pain During Swallowing, and Thirst Following Thyroid Surgery: A Randomized Controlled Trial
Dysphagia and thirst are common in the early period after thyroidectomy and negatively affect patient comfort. This study aims to evaluate the effect of cold water spray on dysphagia, pain during swallowing, and thirst after thyroid surgery. In this randomized controlled trial, patients will be divided into two groups. Patients in the experimental group (n=54) will receive +4 °C cold water sprayed into the mouth once every hour for 6 hours postoperatively, while the control group (n=54) will receive routine care. In both groups, data will be collected hourly for 6 hours.
Read the detailed description
Thyroidectomy is a common surgical procedure, and dysphagia caused by edema and mechanical trauma frequently occurs in the early postoperative period. This condition may reduce patient satisfaction and prolong recovery. Thirst, which patients describe as a highly distressing experience, begins with preoperative fasting and fluid restriction and may persist into the postoperative period. Unrelieved thirst is perceived as more severe than other postoperative discomforts. Managing these symptoms through nursing interventions is therefore important for postoperative comfort. This study aims to evaluate the effect of cold water spray on dysphagia, pain during swallowing, and thirst after thyroid surgery.
The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the patients before and after the surgery, the study will conduct with various data collection forms.
These forms are; Descriptive Information Form, Symptom Assessment Form, Perioperative Thirst Discomfort Scale forms will use.
Thyroidectomy will perform and all cases meeting the inclusion criteria will evaluate. Patients will randomize. The cold water spray will apply in group I (n=54), and group II (n=54) will be the control group.
Patients in Group I will receive +4 °C cold water sprayed into the mouth once every hour for 6 hours postoperatively. Group II will be the control group. In both groups, data will be collected hourly for 6 hours using the Symptom Assessment Form and the Perioperative Thirst Discomfort Scale.
- Conditions
- Swallowing Difficulties, Thirst, Thyroidectomy
- Being tested
- Cold water spray
- Keywords
- Swallowing difficulties, Thirst, Thyroidectomy, nursing care
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold water sprayOther
+4 °C cold water will be sprayed into the patient's mouth once every hour for 6 hours postoperatively. Symptoms will be assessed hourly using the Symptom Assessment Form and the Perioperative Thirst Discomfort Scale
| Study group | Role | What they receive |
|---|---|---|
| Cold Water Spray Group | Experimental | Patients in Group I will receive +4 °C cold water sprayed into the mouth once every hour for 6 hours after thyroid surgery. Dysphagia, pain during swallowing, thirst, and dry mouth will be assessed hourly using the Symptom Assessment Form, and thirst discomfort will be assessed using the Perioperative Thirst Discomfort Scale Receives: Other: Cold water spray |
| Control Group | No intervention | Patients in Group II will receive routine postoperative nursing care. No cold water application will be performed. Dysphagia, pain during swallowing, thirst, and dry mouth will be assessed hourly for 6 hours using the Symptom Assessment Form, and thirst discomfort will be assessed using the Perioperative Thirst Discomfort Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing Difficulty Severity
Dysphagia severity will be assessed using a Visual Analog Scale (VAS) in the Symptom Assessment Form. Scores range from 0 (none) to 10 (very severe); higher scores indicate greater severity
Measured: Hourly for 6 hours postoperatively
Pain During Swallowing
Pain during swallowing will be assessed using a Visual Analog Scale (VAS) in the Symptom Assessment Form. Scores range from 0 (none) to 10 (very severe); higher scores indicate greater severity
Measured: Hourly for 6 hours postoperatively
Thirst Intensity
Thirst intensity will be assessed using a Visual Analog Scale (VAS) in the Symptom Assessment Form. Scores range from 0 (none) to 10 (very severe); higher scores indicate greater severity
Measured: Hourly for 6 hours postoperatively
Dry Mouth Severity
Dry mouth severity will be assessed using a Visual Analog Scale (VAS) in the Symptom Assessment Form. Scores range from 0 (none) to 10 (very severe); higher scores indicate greater severity
Measured: Hourly for 6 hours postoperatively
Perioperative Thirst Discomfort
Thirst discomfort will be assessed using the Perioperative Thirst Discomfort Scale. The scale consists of 7 items scored from 0 to 2, with total scores ranging from 0 to 14; higher scores indicate greater thirst discomfort
Measured: Hourly for 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start12 Oct 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Swallowing DifficultiesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Ilkaz, RN, PhD, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879404
- Sponsor's protocol ID
- 46418926-2026-247
- Acronym
- CWS-THY
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dığın, F., Kızılcık Özkan, Z. & Mayda, Z. (2025). Evaluation of thirst symptoms in patients undergoing abdominal surgery. Fenerbahce University Journal of Health Sciences, 5(2), 247-255. DOI: 10.56061/fbujohs.1691951
Pierotti, I., Fracarolli, I. F. L., Fonseca, L. F., & Aroni, P. (2018). Evaluation of the intensity and discomfort of perioperative thirst. Escola Anna Nery, 22, e20170375
Conchon MF, Nascimento LA, Fonseca LF, Aroni P. [Perioperative thirst: an analysis from the perspective of the Symptom Management Theory]. Rev Esc Enferm USP. 2015 Feb;49(1):122-8. doi: 10.1590/S0080-623420150000100016. Portuguese.
PubMed 25789651Özsoy, H., Güreş, Z., Dolgun, E., & van GIERSBERGEN, M. Y. (2023). Cerrahi Dönem Susuzluğa Bağlı Rahatsızlık Ölçeği (CDSBRÖ) Türkçe Geçerlik ve Güvenirliği. FÜ Sağ Bil Tıp Derg., 37, 237-42
Sorensen JR. The impact of surgery on quality of life, esophageal motility, and tracheal anatomy and airflow in patients with benign nodular goiter. Dan Med J. 2018 Apr;65(4):B5472.
PubMed 29619937Oztas M, Oztas B. Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):214-220. doi: 10.1016/j.jopan.2021.04.018. Epub 2022 Feb 10.
PubMed 35153118Litsou E, Sioka C, Mpakogiannis K, Magou L, Fakitsa P, Giannakis A, Sissy Foteini S, Fousekis F. Thyroidectomy-Related Dysphagia: A Systematic Literature Review. Medicina (Kaunas). 2026 Feb 26;62(3):440. doi: 10.3390/medicina62030440.
PubMed 41901524
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cold Water Spray on Swallowing Difficulty, Pain During Swallowing, and Thirst Following Thyroid Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07879404
- Acronym / sponsor ID
- CWS-THY / 46418926-2026-247
- Conditions
- Swallowing Difficulties, Thirst, Thyroidectomy
- Keywords
- Swallowing difficulties, Thirst, Thyroidectomy, nursing care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 16 Oct 2026 (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.
Dysphagia and thirst are common in the early period after thyroidectomy and negatively affect patient comfort. This study aims to evaluate the effect of cold water spray on dysphagia, pain during swallowing, and thirst after thyroid surgery. In this randomized controlled trial, patients will be divided into two groups. Patients in the experimental group (n=54) will receive +4 °C cold water sprayed into the mouth once every hour for 6 hours postoperatively, while the control group (n=54) will receive routine care. In both groups, data will be collected hourly for 6 hours.
Detailed description
Thyroidectomy is a common surgical procedure, and dysphagia caused by edema and mechanical trauma frequently occurs in the early postoperative period. This condition may reduce patient satisfaction and prolong recovery. Thirst, which patients describe as a highly distressing experience, begins with preoperative fasting and fluid restriction and may persist into the postoperative period. Unrelieved thirst is perceived as more severe than other postoperative discomforts. Managing these symptoms through nursing interventions is therefore important for postoperative comfort. This study aims to evaluate the effect of cold water spray on dysphagia, pain during swallowing, and thirst after thyroid surgery.
The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the patients before and after the surgery, the study will conduct with various data collection forms.
These forms are; Descriptive Information Form, Symptom Assessment Form, Perioperative Thirst Discomfort Scale forms will use.
Thyroidectomy will perform and all cases meeting the inclusion criteria will evaluate. Patients will randomize. The cold water spray will apply in group I (n=54), and group II (n=54) will be the control group.
Patients in Group I will receive +4 °C cold water sprayed into the mouth once every hour for 6 hours postoperatively. Group II will be the control group. In both groups, data will be collected hourly for 6 hours using the Symptom Assessment Form and the Perioperative Thirst Discomfort Scale.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Water Spray Group | Experimental | Other: Cold water sprayPatients in Group I will receive +4 °C cold water sprayed into the mouth once every hour for 6 hours after thyroid surgery. Dysphagia, pain during swallowing, thirst, and dry mouth will be assessed hourly using the Symptom Assessment Form, and thirst discomfort will be assessed using the Perioperative Thirst Discomfort Scale |
| Control Group | No intervention | –Patients in Group II will receive routine postoperative nursing care. No cold water application will be performed. Dysphagia, pain during swallowing, thirst, and dry mouth will be assessed hourly for 6 hours using the Symptom Assessment Form, and thirst discomfort will be assessed using the Perioperative Thirst Discomfort Scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having undergone thyroid surgery
- ASA physical status classification I-II
Key exclusion criteria (8 listed)
- Impaired integrity of the oral and tongue mucosa in the preoperative period
- Having an oral or nasal disease
- Having visual, hearing, speech, or comprehension impairment
- Having diabetes mellitus
- Having a diagnosis of xerostomia (dry mouth)
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 |
|---|---|---|
| Cold water spray+4 °C cold water will be sprayed into the patient's mouth once every hour for 6 hours postoperatively. Symptoms will be assessed hourly using the Symptom Assessment Form and the Perioperative Thirst Discomfort Scale | Other | Cold Water Spray Group |
Primary outcome
Swallowing Difficulty Severity
Time frame: Hourly for 6 hours postoperatively
Dysphagia severity will be assessed using a Visual Analog Scale (VAS) in the Symptom Assessment Form. Scores range from 0 (none) to 10 (very severe); higher scores indicate greater severity
Pain During Swallowing
Time frame: Hourly for 6 hours postoperatively
Pain during swallowing will be assessed using a Visual Analog Scale (VAS) in the Symptom Assessment Form. Scores range from 0 (none) to 10 (very severe); higher scores indicate greater severity
Thirst Intensity
Time frame: Hourly for 6 hours postoperatively
Thirst intensity will be assessed using a Visual Analog Scale (VAS) in the Symptom Assessment Form. Scores range from 0 (none) to 10 (very severe); higher scores indicate greater severity
Dry Mouth Severity
Time frame: Hourly for 6 hours postoperatively
Dry mouth severity will be assessed using a Visual Analog Scale (VAS) in the Symptom Assessment Form. Scores range from 0 (none) to 10 (very severe); higher scores indicate greater severity
Perioperative Thirst Discomfort
Time frame: Hourly for 6 hours postoperatively
Thirst discomfort will be assessed using the Perioperative Thirst Discomfort Scale. The scale consists of 7 items scored from 0 to 2, with total scores ranging from 0 to 14; higher scores indicate greater thirst discomfort
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 20 Oct 2026.
- BackgroundDığın, F., Kızılcık Özkan, Z. & Mayda, Z. (2025). Evaluation of thirst symptoms in patients undergoing abdominal surgery. Fenerbahce University Journal of Health Sciences, 5(2), 247-255. DOI: 10.56061/fbujohs.1691951
- BackgroundPierotti, I., Fracarolli, I. F. L., Fonseca, L. F., & Aroni, P. (2018). Evaluation of the intensity and discomfort of perioperative thirst. Escola Anna Nery, 22, e20170375
- Background: PubMed 25789651Conchon MF, Nascimento LA, Fonseca LF, Aroni P. [Perioperative thirst: an analysis from the perspective of the Symptom Management Theory]. Rev Esc Enferm USP. 2015 Feb;49(1):122-8. doi: 10.1590/S0080-623420150000100016. Portuguese.
- BackgroundÖzsoy, H., Güreş, Z., Dolgun, E., & van GIERSBERGEN, M. Y. (2023). Cerrahi Dönem Susuzluğa Bağlı Rahatsızlık Ölçeği (CDSBRÖ) Türkçe Geçerlik ve Güvenirliği. FÜ Sağ Bil Tıp Derg., 37, 237-42
- Background: PubMed 29619937Sorensen JR. The impact of surgery on quality of life, esophageal motility, and tracheal anatomy and airflow in patients with benign nodular goiter. Dan Med J. 2018 Apr;65(4):B5472.
- Background: PubMed 35153118Oztas M, Oztas B. Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):214-220. doi: 10.1016/j.jopan.2021.04.018. Epub 2022 Feb 10.
- Background: PubMed 41901524Litsou E, Sioka C, Mpakogiannis K, Magou L, Fakitsa P, Giannakis A, Sissy Foteini S, Fousekis F. Thyroidectomy-Related Dysphagia: A Systematic Literature Review. Medicina (Kaunas). 2026 Feb 26;62(3):440. doi: 10.3390/medicina62030440.
- Individual participant dataSharing planned: No
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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 Cold water spray in people with Swallowing Difficulties and Thirst, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 2 inclusion and 8 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 20 Oct 2026. 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?
Swallowing Difficulty Severity (time frame: Hourly for 6 hours postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07879404, which also lists 7 linked publications.
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 20 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.