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

Application Site Discomfort Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108687
• Other study ID #: GaziantepIslamST
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Gaziantep Islam Science and Technology University
• Contact: Zehra ÇERÇER, PhD
• Phone: +90 (342) 909 75 00
• Email: zehra.cercer[@]gibtu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 undergoing gynecological surgery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Application Site Discomfort

Intervention

Other:
• water spray application
cold water kept in the refrigerator at +4 degrees

Locations

Country	Name	City	State
Turkey	Adana city training and research hospital	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Gaziantep Islam Science and Technology University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1st, 3rd, 5th, 6th hours postoperatively
Secondary	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).	1st, 3rd, 5th, 6th hours postoperatively