The Effect Thirsty and Oral Care Frequency of Cold Water

July 10, 2023 updated by: SERAP GÜNGÖR, Kahramanmaras Sutcu Imam University
Surgical patients, and especially bariatric patients, are high-risk patients who may develop thirst due to intubation, blood loss, osmotic imbalance, and prolonged fasting. Nurses often have the perception that when the patient's oral intake is turned off, nothing can be done to prevent thirst and dry mouth. Thirst is one of the main stress factors that reduces the comfort of intensive care patients. So far, no assessment has been routinely used to assess thirst and dry mouth. However, thirst is a mitigable symptom that should be evaluated by the nurse.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The data were collected by the researcher by face-to-face interview technique between April 2022 and March 2023 in the groups participating in the study. It was applied to patients who agreed to participate by giving information about the purpose of the study to patients who met the research criteria. The patients were divided into 2 groups as study and control. In the study group, the intensive care oral care frequency assessment scale was applied to 55 patients at the end of the 16th hour, in addition to the assessment of pain and thirst at the 1st, 4th, 8th, and 16th hours postoperatively. It was applied to patients with a thirst of 3 and above by spraying cold water into the mouth of the patient every hour. The standard oral care of the clinic was applied to the patients who needed oral care. In the control group, standard nursing care was applied to 55 patients with the pain, thirst and intensive care oral care frequency assessment scale at the 1st, 4th, 8th, and 16th hours postoperatively.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Kahramanmaraş, Turkey
        • Kahramanmaras Sutcu Imam University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • be between the ages of 18-65, Level of consciousness (level A of AVPU) and orientation (place, direction, time) swallowing and coughing reflex without nausea-vomiting No mandible fracture No dialysis treatment When we ask about their thirst, those who have 3 or more thirst on a scale of 0-10 hungry for more than 6 hours Anesthesia duration exceeding 1 hour Patients not receiving Mechanical Ventilator support undergoing elective surgery Individuals who can communicate at a level that can answer the research questions will be included.

Those who do not use dentures

Exclusion Criteria:

  • be over 65, under 18 Having lesions on the oral mucosa and lips Having any disease that prevents communication such as Alzheimer's, dementia Patients with a thirst feeling of 3 or less during the cold spray application

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
In the study group, the intensive care oral care frequency assessment scale was applied to 55 patients at the end of the 16th hour, in addition to the assessment of pain and thirst at the 1st, 4th, 8th, and 16th hours postoperatively. In patients with a thirst of 3 and above, the bedside was lifted 30-450 times (to prevent bronchoaspiration), and cold water spray (kept in the refrigerator at +4°C and stored) was sprayed 3 times (approximately 2 ml) into the mouth of the patient every hour. Evidence suggests that the risk of bronchoaspiration is minimal up to the 50 mL and 1.5 mL/kg limit of gastric volume (Doi et al., 2021). For this, it is thought that the application of an average of 32 ml of cold water applied to the patients is reliable. The standard oral care of the clinic was applied to the patients who needed oral care. It was also recorded how many times oral care was given to the patients included in the study within 16 hours.
Behavioral: the intensive oral care
the intensive oral care
No Intervention: control group
In the control group, standard nursing care was applied to 55 patients with the pain, thirst and intensive care oral care frequency assessment scale at the 1st, 4th, 8th, and 16th hours postoperatively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study Group Outcome
Time Frame: 16 hours
In the study group, 55 patients were evaluated for pain and thirst at the 1st, 4th, 8th and 16th postoperative hours and the intensive care oral care frequency assessment scale was additionally applied at the end of the 16th hour without oral care.
16 hours
Control Group Outcome
Time Frame: 16 hours
In the control group, standard nursing care was applied to 55 patients at the 1st, 4th, 8th, 16th postoperative hours with the intensive care oral care frequency assessment scale at the end of the 16th hour without pain, thirst and oral care.
16 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Thisrty

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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