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

Sponsor
Gaziantep Islam Science and Technology University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06108687
Collaborator
(none)
70
1
2
16.4
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: water spray application
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Intraoral Spray Application on Thirst and Thirst Comfort in Patients Undergoing Gynecological Surgery: A Randomized Controlled Study
Actual Study Start Date :
Aug 20, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Thirst Severity Scale (Numerical Rating Scale) [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).

Secondary Outcome Measures

  1. Thirst Discomfort Scale [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Adana city training and research hospital Adana Turkey

Sponsors and Collaborators

  • Gaziantep Islam Science and Technology University

Investigators

  • Principal Investigator: Zehra ÇERÇER, PhD, Gaziantep İslam 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zehra Çerçer, Lecturer, Gaziantep Islam Science and Technology University
ClinicalTrials.gov Identifier:
NCT06108687
Other Study ID Numbers:
  • GaziantepIslamST
First Posted:
Oct 31, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zehra Çerçer, Lecturer, Gaziantep Islam Science and Technology University

Study Results

No Results Posted as of Nov 2, 2023