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

December 23, 2024 updated by: Zehra Çerçer, Gaziantep Islam Science and Technology University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey
        • Adana City Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experiment

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 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.
Other: water spray application
cold water kept in the refrigerator at +4 degrees
No Intervention: Control
Spray application will not be applied to patients in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1st, 3rd, 5th, 6th hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thirst Discomfort Scale
Time Frame: 1st, 3rd, 5th, 6th hours postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziantep Islam Science and Technology University

Investigators

  • Principal Investigator: Zehra ÇERÇER, PhD, Gaziantep Islam Science and Technology University
  • Study Chair: Serap GÜNGÖR, PhD, Kahramanmaraş Sütçü İmam University
  • Study Chair: Esra BULMUŞ, Msc, Adana City Training Hospital
  • Study Chair: Sefa ARLIER, MD, Adana City Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Actual)

August 15, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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