NCT06108687

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

October 25, 2023

Last Update Submit

December 23, 2024

Conditions

Keywords

Gynecologic surgerywater spraydiscomfortthirst

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

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 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

Control

NO INTERVENTION

Spray application will not be applied to patients in the control group.

Interventions

cold water kept in the refrigerator at +4 degrees

Experiment

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWoman
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 35153118BACKGROUND
  • 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.

    PMID: 36812765BACKGROUND
  • 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.

    PMID: 32999369BACKGROUND
  • 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.

    PMID: 37121897BACKGROUND

Study Officials

  • Zehra ÇERÇER, PhD

    Gaziantep İslam Science and Technology University

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

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

Locations