The Effect of Intraoral Spray Application on Thirst and Thirst Comfort in Patients Undergoing Gynecological Surgery
1 other identifier
interventional
58
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 31, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2024
CompletedDecember 27, 2024
December 1, 2024
9 months
October 25, 2023
December 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Thirst Discomfort Scale
1st, 3rd, 5th, 6th hours postoperatively
Study Arms (2)
Experiment
EXPERIMENTALIn 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 3 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 INTERVENTIONSpray application will not be applied to patients in the control group.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adana city training and research hospital
Adana, Turkey (Türkiye)
Related Publications (4)
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.
PMID: 35153118BACKGROUNDCan 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.
PMID: 36812765BACKGROUNDLee 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.
PMID: 32999369BACKGROUNDCiftci 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.
PMID: 37121897BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Zehra ÇERÇER, PhD
Gaziantep İslam Science and Technology University
- STUDY CHAIR
Serap GÜNGÖR, PhD
Kahramanmaras Sutcu Imam University
- STUDY CHAIR
Esra BULMUŞ, Msc
Adana City Training Hospital
- STUDY CHAIR
Sefa ARLIER, MD
Adana City Training Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
October 25, 2023
First Posted
October 31, 2023
Study Start
November 15, 2023
Primary Completion
August 15, 2024
Study Completion
August 15, 2024
Last Updated
December 27, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share