NCT07397221

Brief Summary

In patients who have undergone endotracheal intubation following cardiac surgery, symptoms such as thirst, dysphagia (difficulty swallowing), restlessness, nausea, and vomiting are frequently observed, and these conditions negatively affect the patients' overall comfort. Especially in the post-intubation period, dryness in the mouth and throat, an intense feeling of thirst, and difficulty swallowing can lead to feelings of suffocation, helplessness, fear, and anxiety in patients. Effective management of these symptoms is critically important both for accelerating the recovery process and for increasing patient satisfaction. Traditionally, methods such as moistening the mouth with a cotton swab have been used to relieve complaints like thirst and dry mouth. However, these practices are often insufficient and have limited effectiveness in increasing patients' comfort. In recent years, the use of oropharyngeal sprays has emerged as an innovative and effective approach to alleviate symptoms such as thirst and dry mouth. In a randomized controlled trial conduct, it was shown that a spray-based oropharyngeal moisturizing program significantly reduced the severity of thirst and discomfort in patients who underwent intubation after cardiac surgery. Thirst and discomfort scores were found to be significantly lower in the spray-applied groups compared to the control group, and no significant difference was observed between the groups in terms of dysphagia frequency or adverse events. Similarly, studies conducted in different surgical and intensive care populations have shown that applications of cold water or cold saline sprays significantly reduce complaints of thirst and dry mouth, increase patient comfort, and are safe to use. Additionally, it has been reported that alternative approaches such as menthol lozenges or aromatherapy also have positive effects on thirst, nausea, and comfort after cardiac surgery. Examining the effects of oropharyngeal sprays and similar practices on parameters such as thirst, dysphagia, discomfort, nausea, vomiting, and overall comfort in patients who are intubated after cardiac surgery may contribute to the development of innovative and effective approaches in patient care. Integrating such practices into postoperative care protocols carries significant potential for increasing patient comfort and supporting the recovery process. This randomized controlled study aims to investigate the effects of oropharyngeal humidification after extubation on thirst, pain, and anxiety in patients undergoing coronary artery bypass surgery.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Feb 2026Aug 2026

Study Start

First participant enrolled

February 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 11, 2026

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

February 2, 2026

Last Update Submit

February 9, 2026

Conditions

Keywords

Oropharyngeal HumidificationThirstPainCoronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (1)

  • Thirst Severity

    The Numeric Rating Scale is used for patients to indicate the severity of their thirst. Patients will be asked to rate their feeling of thirst on a scale from 0 to 10. A score of 0 means no thirst at all. An increase in the score indicates increasing thirst. A score of 10 represents extreme thirst.

    Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention

Secondary Outcomes (4)

  • Thirst-Related Discomfort

    Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention

  • Pain Severity

    Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention

  • Anxiety Level

    Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention

  • Post-Extubation Complications

    Continuous monitoring during the 4-hour intervention period

Study Arms (2)

Oropharyngeal Humidification

EXPERIMENTAL

Participants in this arm will receive oropharyngeal humidification with room-temperature drinking water spray. After tracheal extubation, the researcher applies the spray to multiple oral regions (upper jaw, lower jaw, left cheek, right cheek, tongue) twice per hour for 4 hours.

Other: Oropharyngeal Humidification with Water Spray

Routine Oral Care

NO INTERVENTION

Participants receive only routine oral care provided in the ICU. Nurses use standard methods such as moistening the mouth with wet cotton swabs or lip wetting as needed.

Interventions

Room-temperature drinking water is administered as an oral spray to multiple areas of the oral cavity (upper jaw, lower jaw, left and right cheek, and tongue). The researcher applies the spray twice per hour for 4 hours after extubation in patients undergoing coronary artery bypass surgery.

Oropharyngeal Humidification

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Undergoing coronary artery bypass surgery
  • Postoperative mechanical ventilation and extubation
  • Able to provide informed consent

You may not qualify if:

  • Neuromuscular diseases (e.g., stroke, Parkinson's disease)
  • Head/neck deformities
  • Pre-existing dysphagia
  • Tracheostomy
  • Inability to participate in assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sancaktepe Şehit Prof. Dr. İlhan Varank Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • References Lin, R., Chen, H., Chen, L., Lin, X., He, J., & Li, H. (2022). Effects of a spray-based oropharyngeal moisturising programme for patients following endotracheal extubation after cardiac surgery: A randomised, controlled three-arm trial.. International journal of nursing studies, 130, 104214. https://doi.org/10.1016/j.ijnurstu.2022.104214 Gungor, S., Tosun, B., Candir, G., & Ozen, N. (2024). Effects of cold spray on thirst, frequency of oral care, and pain of general surgery intensive care unit patients. Scientific Reports, 14. https://doi.org/10.1038/s41598-024-58199-0 Lian, R., Zhou, S., Guo, Y., Liang, H., Lin, J., Li, D., Wu, W., Rao, Y., Shao, D., Zheng, P., & Yang, X. (2024). The effect of ice-cold water spray following the model for symptom management on postoperative thirst in patients admitted to intensive care unit: A randomized controlled study.. Intensive & critical care nursing, 81, 103571. https://doi.org/10.1016/j.iccn.2023.103571 Wu, H., Chaou, C., Chang, C., & Wang, H. (2024). [The Comparative Effectiveness of Using Cold Water Oral Spray and Cold Saline Oral Spray for Thirst Relief in Patients With Endotracheal Intubation in the Intensive Care Unit].. Hu li za zhi The journal of nursing, 71 3, 33-42. https://doi.org/10.6224/jn.202406_71(3).06 Ghasemi, A., Mazloum, S., Pourghaznein, T., & Eshraghi, A. (2025). The Impact of Cold Spray Use on Thirst Distress, Dry Mouth, and Fluid Intake in Heart Failure Patients: A Randomized Controlled Study.. The Journal of cardiovascular nursing. https://doi.org/10.1097/jcn.0000000000001183 Liang, T., Li, S., Peng, Y., Chen, Q., Chen, L., & Lin, Y. (2022). Efficacy and Safety of Oral Hydration 1 Hour After Extubation of Patients Undergoing Cardiac Surgery. The Journal of Cardiovascular Nursing, 40, E1 - E8. https://doi.org/10.1097/jcn.0000000000000953 Oztaş, M., & Oztas, B. (2022). Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergoing Maj

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ömer Taşçı, Ph. D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 9, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 11, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations