- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940818
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
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
Interventional
Enrollment (Actual)
55
Phase
- 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
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Kahramanmaraş, Turkey
- Kahramanmaraş Sütçü İmam University
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
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the intensive oral care
|
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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
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.
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16 hours
|
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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.
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16 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 1, 2022
Primary Completion (Actual)
September 15, 2022
Study Completion (Actual)
March 30, 2023
Study Registration Dates
First Submitted
July 2, 2023
First Submitted That Met QC Criteria
July 10, 2023
First Posted (Actual)
July 11, 2023
Study Record Updates
Last Update Posted (Actual)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 10, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID 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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