ThirstNCT05940818
The Effect Thirsty and Oral Care Frequency of Cold Water
A study testing the intensive oral care in people with Thirst, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thirst
- What is being tested?
- the intensive oral care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş
About this study
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.
Read the 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.
- Conditions
- Thirst
- Being tested
- the intensive oral care
- Keywords
- Postoperative Period, ice, nursing, thirst, Intensive care units, mouth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the intensive oral careBehavioural
the intensive oral care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Apr 2022
- Primary completion15 Sep 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThirstStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP GÜNGÖR, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940818
- Sponsor's protocol ID
- Thisrty
- Status last verified
- Jul 2023
- First submitted
- 2 Jul 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Thirsty and Oral Care Frequency of Cold Water
- ClinicalTrials.gov ID
- NCT05940818
- Acronym / sponsor ID
- Thisrty
- Conditions
- Thirst
- Keywords
- Postoperative Period, ice, nursing, thirst, Intensive care units, mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: the intensive oral careIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the intensive oral carethe intensive oral care | Behavioural | experimental group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the intensive oral care in people with Thirst, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Group Outcome (time frame: 16 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.