NCT06507696

Brief Summary

Postoperative thirst is one of the most common problems in patients. Thirst is a subjective symptom. Thirst can cause unwanted problems in patients such as anxiety, discomfort and nausea. It may even cause anxiety, hypertension, dysrhythmia, non-compliance with treatment and increased need for anesthesia. Although different methods have been applied in the management of thirst in the existing literature and positive results have been obtained, studies with high evidence value are very limited. The aim of this study was to compare the effectiveness of two different methods in thirst management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 12, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

thirst managementpostoperative caresurgical patientsurgical thirsty

Outcome Measures

Primary Outcomes (1)

  • Thirst score

    Visual Comparion Scale (VCS) was used to assess thirst. In this scale, thirst was graded from 0 to 10. 0=no thirst, 10=the most severe thirst. The scale was evaluated as 0-3 points mild thirst, 4-6 points moderate thirst, 7-10 points severe thirst. * First follow-up (T1): Patient's thirst level measured by VCS and intervention (ice application or wet gauze application) * Second follow-up (T2); evaluation was performed with VCS 5 minutes after the application. * Third follow-up (T3); evaluation was performed with VCS 30 minutes after the application. * Fourth follow-up (T4); assessment was performed with VCS 60 minutes after the application. Fifth follow-up (T5); evaluation was performed with VCS 90 minutes after the application. The thirst level of the patient was measured 5 times in total. At 90 minutes, data collection was terminated. Scores between 5 measurement values were compared.

    Using Thirst Visual Comparion Scale score after immediately after surgery (T1) 5th min.(T2), 30th min.(T3), 60th min.(T4), 90th min.(T5)

Study Arms (3)

Ice Application

EXPERIMENTAL

* In ice application, 5 ml of drinking water was filled in a 10 ml syringe and frozen by inserting a plastic piston into it and then these frozen ice cubes were given into the mouths of the patients. * The ice cubes were prepared before the application and stored in the freezer section of the refrigerator. * The ice was taken out of the frozen syringe and the nurse moved it around the patient's mouth to melt it. * By holding the ice cubes from the piston part to the researcher, the patient was allowed to suck and melt them in the mouth.

Other: Ice Application

Wetted Gauze Application

EXPERIMENTAL

* During wetted gauze application, sterile gauze swabs were wetted with drinking water. * Sterile gauze swabs (10 cm\*10cm) were wetted with 5 ml and applied for 5 minutes. * The wetted end part of the gauze swabs was allowed to be sucked in the patient's mouth by the researcher.

Other: Wetted Gauze Application

No intervention

NO INTERVENTION

Patients in the control group did not receive any application

Interventions

Drinking water was placed in a syringe and filled in the refrigerator

Ice Application

Sterile gauze soaked with drinking water

Wetted Gauze Application

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-65 years
  • undergoing elective surgery
  • Patients undergoing surgery other than gastrointestinal system surgery
  • Patients in class I, II, III according to the American anesthesiologists' association classification (ASA)
  • Patients who have completed a minimum of 6 hours of strict fasting and 3 hours of thirst
  • Patients who can verbally express a thirst level of 4 points or more according to visual benchmark scale in the early postoperative period
  • Patients who comply with the safety protocol in the early postoperative period
  • Patients who can express their thirst in the early postoperative period/recovery unit
  • Patients with a duration of surgical anesthesia ≥1 hour and taken to the recovery unit at the end of surgery will be included in the study.

You may not qualify if:

  • Emergency planned surgeries
  • Patients who had a second surgical intervention during the hospitalization period
  • Patients who need intensive care after surgery
  • Patients with problems in the extubation process after surgery
  • Patients with altered state of consciousness after surgery
  • Patients with fluid electrolyte imbalance (hypovolemia and sodium imbalance)
  • Patients with swallowing difficulties and fluid intake restriction
  • Foreign patients with language barriers
  • Patients with menthol allergy
  • Patients with problems in the head, neck, throat and mouth will be excluded from the sample.
  • Women who have just given birth and are breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yasemin Uslu

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

Location

Acıbadem University

Istanbul, Eyalet/Yerleşke, 34752, Turkey (Türkiye)

Location

Related Publications (6)

  • Serato VM, Fonseca LF, Birolim MM, Rossetto EG, Mai LD, Garcia AKA. Package of menthol measures for thirst relief: a randomized clinical study. Rev Bras Enferm. 2019 Jun 27;72(3):600-608. doi: 10.1590/0034-7167-2018-0057. English, Portuguese.

  • Peyrot des Gachons C, Avrillier J, Gleason M, Algarra L, Zhang S, Mura E, Nagai H, Breslin PA. Oral Cooling and Carbonation Increase the Perception of Drinking and Thirst Quenching in Thirsty Adults. PLoS One. 2016 Sep 29;11(9):e0162261. doi: 10.1371/journal.pone.0162261. eCollection 2016.

  • Nascimento LAD, Garcia AKA, Conchon MF, Aroni P, Pierotti I, Martins PR, Nakaya TG, Fonseca LF. Advances in the Management of Perioperative Patients' Thirst. AORN J. 2020 Feb;111(2):165-179. doi: 10.1002/aorn.12931.

  • Nascimento LA, Fonseca LF, Rosseto EG, Santos CB. [Development of a safety protocol for management thirst in the immediate postoperative period]. Rev Esc Enferm USP. 2014 Oct;48(5):834-43. doi: 10.1590/s0080-6234201400005000009. Portuguese.

  • Conchon MF, Fonseca LF. Efficacy of an Ice Popsicle on Thirst Management in the Immediate Postoperative Period: A Randomized Clinical Trial. J Perianesth Nurs. 2018 Apr;33(2):153-161. doi: 10.1016/j.jopan.2016.03.009. Epub 2017 Mar 21.

  • Cho EA, Kim KH, Park JY. [Effects of frozen gauze with normal saline and ice on thirst and oral condition of laparoscopic cholecystectomy patients: pilot study]. J Korean Acad Nurs. 2010 Oct;40(5):714-23. doi: 10.4040/jkan.2010.40.5.714. Korean.

MeSH Terms

Conditions

Patient SatisfactionPostoperative Complications

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fevzi Toraman, Prof. Dr.

    Acıbadem Mehmet Ali Aydınlar Üniversitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel Assignment Randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 18, 2024

Study Start

January 1, 2023

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations