NCT05940818

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

July 2, 2023

Last Update Submit

July 10, 2023

Conditions

Keywords

Postoperative PeriodicenursingthirstIntensive care unitsmouth

Outcome Measures

Primary Outcomes (2)

  • Study Group Outcome

    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

    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

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

the intensive oral care

experimental group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2023

First Posted

July 11, 2023

Study Start

April 1, 2022

Primary Completion

September 15, 2022

Study Completion

March 30, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations