Coronary Artery BypassNCT07397221
Oropharyngeal Humidification After Extubation on Thirst
A study testing Oropharyngeal Humidification with Water Spray in people with Coronary Artery Bypass, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Oropharyngeal Humidification with Water Spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Aug 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Undergoing coronary artery bypass surgery
- Postoperative mechanical ventilation and extubation
- Able to provide informed consent
Who cannot join
- Neuromuscular diseases (e.g., stroke, Parkinson's disease)
- Head/neck deformities
- Pre-existing dysphagia
- Tracheostomy
- Inability to participate in assessments
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
Sancaktepe Şehit Prof. Dr. İlhan Varank Eğitim ve Araştırma Hastanesi
Istanbul
Ömer Taşçı, Ph. D., +90 0436 212 49 49, o.tasci@alparslan.edu.tr
ömer taşçı, Ph. D.
About this study
Official title: 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.
Read more
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.
- Conditions
- Coronary Artery Bypass
- Being tested
- Oropharyngeal Humidification with Water Spray
- Keywords
- Oropharyngeal Humidification, Thirst, Pain, Coronary Artery Bypass Surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal Humidification with Water SprayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
Secondary outcomes (4)
Thirst-Related Discomfort
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.
Measured: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
Pain Severity
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.
Measured: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
Anxiety Level
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.
Measured: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
Post-Extubation Complications
Complications such as coughing, oxygen desaturation, nausea-vomiting, or dysphagia are recorded.
Measured: Continuous monitoring during the 4-hour intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tasci, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397221
- Sponsor's protocol ID
- 218984
- Status last verified
- Nov 2025
- First submitted
- 2 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oropharyngeal Humidification After Extubation on Thirst, Pain, and Anxiety in Patients Undergoing Coronary Artery Bypass Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07397221
- Acronym / sponsor ID
- 218984
- Conditions
- Coronary Artery Bypass
- Keywords
- Oropharyngeal Humidification, Thirst, Pain, Coronary Artery Bypass Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Feb 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal Humidification | Experimental | Other: Oropharyngeal Humidification with Water SprayParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65
- Undergoing coronary artery bypass surgery
- Postoperative mechanical ventilation and extubation
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Neuromuscular diseases (e.g., stroke, Parkinson's disease)
- Head/neck deformities
- Pre-existing dysphagia
- Tracheostomy
- Inability to participate in assessments
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 |
|---|---|---|
| Oropharyngeal Humidification with Water SprayRoom-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. | Other | Oropharyngeal Humidification |
Primary outcome
Thirst Severity
Time frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
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.
4 secondary outcomes
Thirst-Related Discomfort
Time frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
Pain Severity
Time frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
Anxiety Level
Time frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention
Post-Extubation Complications
Time frame: Continuous monitoring during the 4-hour intervention period
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 11 Feb 2026.
- BackgroundReferences 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
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oropharyngeal Humidification with Water Spray in people with Coronary Artery Bypass, run by Muş Alparslan 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Feb 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?
Contact Ömer Taşçı, Ph. D. (+90 0436 212 49 49, o.tasci@alparslan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thirst Severity (time frame: Baseline (immediately after extubation) 2 hours post-intervention 4 hours post-intervention). 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 NCT07397221, which also lists 1 linked publication.
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 11 Feb 2026.