NCT04070911

Brief Summary

The study was conducted to determine the effect of oral water and ice popsicle on management of thirst in the immediate postoperative period as experimental.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

May 23, 2019

Last Update Submit

August 26, 2019

Conditions

Keywords

Perioperative nursingPostanesthesia careThirstWaterIce

Outcome Measures

Primary Outcomes (1)

  • THIRSTY SCALE

    Thirsty and symptoms of thırsty evaluated via vısual analog scale which containing numbers from zero to ten (0-10), "0" is the minumun point, "10" is the maximum point, higher values represent a better situation.

    first 30 minutes after the surgery

Secondary Outcomes (4)

  • The blood pressure measurements in the first 30 minutes after surgery

    first 30 minutes after surgery

  • The heart rate measurements in the first 30 minutes after surgery

    first 30 minutes after surgery

  • The respiratory rate measurements in the first 30 minutes after surgery

    first 30 minutes after surgery

  • The body temperature measurements in the first 30 minutes after surgery

    first 30 minutes after surgery

Study Arms (3)

patients in the water group

EXPERIMENTAL

water group: Patients in the water group were performed oral water after their accession to PACU.

Other: WATER

patients in the ice group

EXPERIMENTAL

ice group, Patients in the ice group were performed oral ice popsicle after their accession to PACU.

Other: ICE APPLICATION

no intervention group

NO INTERVENTION

control group, the control group patients have performed rutin treatment and care without any other intervention

Interventions

WATEROTHER

ORAL WATER

patients in the water group

ICE APPLICATION

patients in the ice group

Eligibility Criteria

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

You may qualify if:

  • have a surgical operation other than gastrointestinal system surgery,
  • Surgical fasting duration is at least 8 hours,
  • According to the American Society of Anesthesiologists (ASA) classification; Class I, II and III;
  • Having the ability to express the thirst status verbally and experiencing moderate or severe thirst when the thirst status is evaluated by VAS,
  • The duration of anesthesia is longer than 1 hour and accepted into the PACU after surgery.

You may not qualify if:

  • have a second surgical intervention during hospitalization,
  • The need of intensive care after surgery,
  • Having problems in the process of separation from respiratory support after surgical intervention,
  • A change in the state of consciousness after surgical intervention / acute confusion,
  • Liquid electrolyte imbalance,
  • Patients with difficulty in swallowing or restriction of oral fluid intake,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Kavacık, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • seher deniz öztekin, Prof.Dr.

    thesis advisor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: RANDOMIZED CONTROLLED STUDY GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

August 28, 2019

Study Start

November 24, 2015

Primary Completion

July 13, 2018

Study Completion

July 13, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations