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
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