Application Site DiscomfortNCT06108687

The Effect of Intraoral Spray Application on Thirst and Thirst Comfort in Patients Undergoing Gynecological Surgery

A study testing water spray application in people with Application Site Discomfort, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

It is important for healthcare professionals to provide care for gynecologic surgery patients using current evidence-based approaches. In this context, this study was planned to determine the effect of intraoral cold water spray application on thirst and thirst comfort in the postoperative period in patients… Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Application Site Discomfort
What is being tested?: water spray application
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Nov 2023to 15 Aug 2024
Phase: Interventional
Are there results?: None posted in the registry

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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Being a patient who is scheduled for benign laparoscopic elective gynecological surgery under general anesthesia,
No upper gastrointestinal system anomaly and/or disease,
Being a patient whose score is classified as grade I or II according to the American Society of Anesthesiologists (ASA),
Being between the ages of 18-65,
Not smoking,
Being able to communicate at a level that can answer research questions.

Who cannot join

The integrity of the oral and tongue mucosa is disrupted before surgery,
Having cognitive impairment or any neurological, renal, cardiac or pulmonary chronic disease,
Morbidly obese
Those who use psychiatric drugs

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Adana city training and research hospital
Adana

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Intraoral Spray Application on Thirst and Thirst Comfort in Patients Undergoing Gynecological Surgery: A Randomized Controlled Study

Read the detailed description

Hypotheses of the Research H01: Application of cold water spray into the mouth has no effect on thirst in patients undergoing gynecological surgery.

H02: Application of cold water spray into the mouth has no effect on thirst comfort in patients undergoing gynecological surgery.

H11: Application of cold water spray into the mouth has an effect on thirst in patients undergoing gynecological surgery.

H12: Application of cold water spray into the mouth has an effect on thirst comfort in patients undergoing gynecological surgery.

Conditions: Application Site Discomfort
Being tested: water spray application
Keywords: Gynecologic surgery, water spray, discomfort, thirst

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

water spray applicationOther
cold water kept in the refrigerator at +4 degrees

Study groups in NCT06108687
Study group	Role	What they receive
Experiment	Experimental	In cold water applications, 50 cc bottles with plastic spray heads will be used. New materials will be used for each patient. Interventions will be carried out by the researcher and. Cold water kept in the refrigerator at +4 degrees will be placed in 50 cc spray bottles for the experimental group and will be sprayed orally to the patients 4 times an hour in the postoperative period. The spray will be applied to the patient's mouth, upper palate, top of the tongue, right inner cheek, and left inner cheek. Patients will be given approximately 0.5 mL of water via spray in each application. Receives: Other: water spray application
Control	No intervention	Spray application will not be applied to patients in the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Thirst Severity Scale (Numerical Rating Scale)
This scale was determined based on studies in the literature where the severity of thirst was evaluated using a numerical rating scale. It will be used to objectively evaluate the thirst levels of patients. It will be evaluated between 0-10 points with SDQ. While a score of 0 indicates that there is no thirst, a score of 10 indicates that the most severe thirst is felt. (Lee et al. 2020).
Measured: 1st, 3rd, 5th, 6th hours postoperatively

Secondary outcomes (1)

Thirst Discomfort Scale
The Turkish validity and reliability of the scale was conducted by Çiftçi et al. in 2023. The scale is used to determine the level of dehydration-related discomfort in surgical patients. There are 3 sub-dimensions in the scale (intraoral movements, psychological movements, extraoral movements). The scale was developed as a 5-point Likert type. It is scored as "1 = It does not bother me at all", "5 = It bothers me a lot". The Thirst Disorder Scale is calculated based on the total item score. There are no reverse items in the scale. The lowest score from the scale is 12 and the highest score is 60. As the score obtained from the sub-dimension increases, the level of discomfort in that dimension increases. As the score obtained from the scale increases, the level of thirst discomfort of patients increases (Çiftçi et al., 2023).
Measured: 1st, 3rd, 5th, 6th hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202315 Aug 2024

First posted31 Oct 2023
Study start15 Nov 2023
Primary completion15 Aug 2024
Study completion15 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Application Site DiscomfortStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06108687
Sponsor's protocol ID: 133
Status last verified: Jun 2026
First submitted: 25 Oct 2023
Last updated: 24 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Oztas 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 35153118
Can S, Gezginci E, Yapici N. Effect of menthol lozenges after extubation on thirst, nausea, physiological parameters, and comfort in cardiovascular surgery patients: A randomized controlled trial. Intensive Crit Care Nurs. 2023 Jun;76:103415. doi: 10.1016/j.iccn.2023.103415. Epub 2023 Feb 20.
PubMed 36812765
Lee CW, Liu ST, Cheng YJ, Chiu CT, Hsu YF, Chao A. Prevalence, risk factors, and optimized management of moderate-to-severe thirst in the post-anesthesia care unit. Sci Rep. 2020 Sep 30;10(1):16183. doi: 10.1038/s41598-020-73235-5.
PubMed 32999369
Ciftci B, Yildiz GN, Avsar G, Kose S, Aydin E, Dogan S, Celik S. Development of the Thirst Discomfort Scale: A Validity and Reliability Study. Am J Crit Care. 2023 May 1;32(3):176-183. doi: 10.4037/ajcc2023954.
PubMed 37121897

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Intraoral Spray Application on Thirst and Thirst Comfort in Patients Undergoing Gynecological Surgery: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT06108687
Acronym / sponsor ID: 133
Conditions: Application Site Discomfort
Keywords: Gynecologic surgery, water spray, discomfort, thirst
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
Study start: 15 Nov 2023 (actual)
Primary completion: 15 Aug 2024 (actual)
Study completion: 15 Aug 2024 (actual)
First posted: 31 Oct 2023 (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.

Detailed description

Hypotheses of the Research H01: Application of cold water spray into the mouth has no effect on thirst in patients undergoing gynecological surgery.

H02: Application of cold water spray into the mouth has no effect on thirst comfort in patients undergoing gynecological surgery.

H11: Application of cold water spray into the mouth has an effect on thirst in patients undergoing gynecological surgery.

H12: Application of cold water spray into the mouth has an effect on thirst comfort in patients undergoing gynecological surgery.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experiment	Experimental	Other: water spray applicationIn cold water applications, 50 cc bottles with plastic spray heads will be used. New materials will be used for each patient. Interventions will be carried out by the researcher and. Cold water kept in the refrigerator at +4 degrees will be placed in 50 cc spray bottles for the experimental group and will be sprayed orally to the patients 4 times an hour in the postoperative period. The spray will be applied to the patient's mouth, upper palate, top of the tongue, right inner cheek, and left inner cheek. Patients will be given approximately 0.5 mL of water via spray in each application.
Control	No intervention	–Spray application will not be applied to patients in the control group.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Being a patient who is scheduled for benign laparoscopic elective gynecological surgery under general anesthesia,
No upper gastrointestinal system anomaly and/or disease,
Being a patient whose score is classified as grade I or II according to the American Society of Anesthesiologists (ASA),
Being between the ages of 18-65,
Not smoking,

Key exclusion criteria (4 listed)

The integrity of the oral and tongue mucosa is disrupted before surgery,
Having cognitive impairment or any neurological, renal, cardiac or pulmonary chronic disease,
Morbidly obese
Those who use psychiatric drugs

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
water spray applicationcold water kept in the refrigerator at +4 degrees	Other	Experiment

Primary outcome

Thirst Severity Scale (Numerical Rating Scale)
Time frame: 1st, 3rd, 5th, 6th hours postoperatively
This scale was determined based on studies in the literature where the severity of thirst was evaluated using a numerical rating scale. It will be used to objectively evaluate the thirst levels of patients. It will be evaluated between 0-10 points with SDQ. While a score of 0 indicates that there is no thirst, a score of 10 indicates that the most severe thirst is felt. (Lee et al. 2020).

1 secondary outcome

Thirst Discomfort Scale
Time frame: 1st, 3rd, 5th, 6th hours postoperatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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 36812765Can S, Gezginci E, Yapici N. Effect of menthol lozenges after extubation on thirst, nausea, physiological parameters, and comfort in cardiovascular surgery patients: A randomized controlled trial. Intensive Crit Care Nurs. 2023 Jun;76:103415. doi: 10.1016/j.iccn.2023.103415. Epub 2023 Feb 20.
Background: PubMed 32999369Lee CW, Liu ST, Cheng YJ, Chiu CT, Hsu YF, Chao A. Prevalence, risk factors, and optimized management of moderate-to-severe thirst in the post-anesthesia care unit. Sci Rep. 2020 Sep 30;10(1):16183. doi: 10.1038/s41598-020-73235-5.
Background: PubMed 37121897Ciftci B, Yildiz GN, Avsar G, Kose S, Aydin E, Dogan S, Celik S. Development of the Thirst Discomfort Scale: A Validity and Reliability Study. Am J Crit Care. 2023 May 1;32(3):176-183. doi: 10.4037/ajcc2023954.
Individual participant dataSharing planned: No

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. This study is not recruiting at the moment.

Zehra ÇERÇER, PhD principal investigator

Gaziantep İslam Science and Technology University

Serap GÜNGÖR, PhD study chair

Kahramanmaras Sutcu Imam University

Esra BULMUŞ, Msc study chair

Adana City Training Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing water spray application in people with Application Site Discomfort, run by Gaziantep Islam Science and Technology 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jun 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Thirst Severity Scale (Numerical Rating Scale) (time frame: 1st, 3rd, 5th, 6th hours postoperatively). 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 NCT06108687, which also lists 4 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 24 Jun 2026.