- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07397221
Oropharyngeal Humidification After Extubation on Thirst
The Effect of Oropharyngeal Humidification After Extubation on Thirst, Pain, and Anxiety in Patients Undergoing Coronary Artery Bypass Surgery: A Randomized Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ömer Taşçı, Ph. D.
- Phone Number: +90 0436 212 49 49
- Email: o.tasci@alparslan.edu.tr
Study Locations
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Istanbul, Turkey (Türkiye)
- Sancaktepe Şehit Prof. Dr. İlhan Varank Eğitim ve Araştırma Hastanesi
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Contact:
- Ömer Taşçı, Ph. D.
- Phone Number: +90 0436 212 49 49
- Email: o.tasci@alparslan.edu.tr
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Principal Investigator:
- ömer taşçı, Ph. D.
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Sub-Investigator:
- Betül İlbey Koç, Ph. D.
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Sub-Investigator:
- Barış Özdere, Ph. D.
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Sub-Investigator:
- Fatma Eti Aslan, Prof. Dr.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65
- Undergoing coronary artery bypass surgery
- Postoperative mechanical ventilation and extubation
- Able to provide informed consent
Exclusion Criteria:
- Neuromuscular diseases (e.g., stroke, Parkinson's disease)
- Head/neck deformities
- Pre-existing dysphagia
- Tracheostomy
- Inability to participate in assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Oropharyngeal Humidification
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.
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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.
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No Intervention: Routine Oral Care
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Thirst Severity
Time Frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
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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.
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Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-Extubation Complications
Time Frame: Continuous monitoring during the 4-hour intervention period
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Complications such as coughing, oxygen desaturation, nausea-vomiting, or dysphagia are recorded.
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Continuous monitoring during the 4-hour intervention period
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Thirst-Related Discomfort
Time Frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
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The Perioperative Thirst Discomfort Scale is a 3-point Likert-type scale consisting of a total of 7 items.
The rating is as follows: Did not disturb (0), Slightly disturbed (1), and Greatly disturbed.
The scale does not have any sub-dimensions.
Higher scores indicate greater thirst.
The total score on the scale ranges from a minimum of 0 to a maximum of 12.
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Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
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Pain Severity
Time Frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
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Visual Analog Scale is used to assess pain.
The patient's pain is evaluated with a score between 0 and 10.
A score of 0 indicates no pain, while a score of 10 represents unbearable pain.
An increase from 0 to 10 indicates increasing pain.
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Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
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Anxiety Level
Time Frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
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The State Anxiety Scale is a 20-item, 4-point Likert-type scale.
The rating is as follows: Almost never (1), Sometimes (2), Often (3), and Almost always (4).
As the score increases, anxiety also increases.
The minimum total score on the scale is 0, and the maximum is 80.
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Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 218984
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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