ThirstNCT06171347
The Effect of Oral Cold Water Spray Application on Thirst Severity in Patients Undergoing Spinal Surgery
A study testing Oral cold spray (tap water) in people with Thirst, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of oral cold water spray application on thirst severity and patient satisfaction after spinal surgery. H1: Oral cold water spray application has an effect on thirst severity after spinal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thirst
- What is being tested?
- Oral cold spray (tap water)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 31 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient treatment in the neurosurgery ward,
- undergoing planned spinal surgery under general anaesthesia,
- Admitted to the ward after surgery,
- Who volunteered to participate in the research,
- No mental disability,
- 18 years of age,
Show all 9Show fewer
- Literate,
- Accepting random selection,
- Patients without communication problems in Turkish
Who cannot join
- Spinal surgery performed under spinal anaesthesia,
- Admitted to intensive care or external ward after surgery,
- Emergency surgery,
- not volunteering to participate in the research,
- Mentally handicapped,
- Under 18 years of age,
Show all 9Show fewer
- Illiterate,
- which does not accept random selection,
- Patients with communication problems in Turkish
Trial locations and contacts
1 site in 1 country.
Emine KOÇ contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Turkey, Trakya University
Edirne, 22030
Zeynep Kızılcık Özkan, PhD, +905056010101, zeynepkizilcik26@hotmail.com
About this study
Official title: The Effect of Oral Cold Water Spray Application on Thirst Severity in Patients Undergoing Spinal Surgery: A Randomised Controlled Trial
The aim of this study was to determine the effect of oral cold water spray application on thirst severity and patient satisfaction after spinal surgery.
H1: Oral cold water spray application has an effect on thirst severity after spinal surgery.
H2: Oral cold water spray application has an effect on salivary pH after spinal surgery.
H3: Oral cold water spray application affects the satisfaction of patients after spinal surgery.
Read the detailed description
The randomized controlled trial will be conducted in the brain and neurosurgery service of Trakya University Health Research and Application Centre. Date of research will be conducted between December 2023 and March 2024. The research sample will consist of 62 volunteer patients. The sample was determined using power analysis at the research planning stage. The minimum number of people to be included in the sample was calculated as 62, each group consisting of 31 (1:1) patients, with an effect size of 0.75, 95% confidence level, 5% tolerance and 80% power ratio, using the G.Power 3.1.9.4 program. Data Collection Forms Patient information form; The form was developed by the researchers in line with the literature and consisted of 9 questions inquiring information about age, gender, educational status, height, body weight, marital status, habits, physician diagnosis, presence of chronic diseases, etc.
ostoperative patient follow-up form; There are 11 questions in the form. The answers to the first 9 questions will be obtained by interviewing the patient face to face. The eleventh question (type of fluid taken during surgery) and the answer to the twelfth question (amount of bleeding during surgery) will be obtained from the anaesthesia transfer form.
The severity of thirst and discomfort levels of the patients will be evaluated numerically four times and saliva pH levels will be evaluated twice (before the first application and 1 hour after the end of the whole application) with the chart at the end of the form (Visual Analogue Scale values). The Visual Analogue Scale, which is used to convert data that cannot be evaluated numerically into numerical form, is 10 cm long and is graded on a horizontal or vertical line. Since thirst is a state of discomfort consisting of subjective experiences expressed by the person, it is stated in the literature that the use of the Visual Analogue Scale in the evaluation of thirst is appropriate and can be used safely in studies. The scale includes 2 questions evaluating the severity of thirst and the severity of discomfort from thirst numerically between 0-10. Patient satisfaction form; The satisfaction of the patients in the experimental group with the oral cold water spray application will be evaluated with a numerical rating scale ranging from 0 to 10 points (0 = I am not satisfied at all, 10 = I am very satisfied).
Data collection process Patients who meet the inclusion criteria will be informed verbally and in writing about the study, scales, etc. in the preoperative period and the informed consent form will be signed. "Patient Information Form" will be applied in the preoperative period. The data of the study will be collected by the researcher in the patient room by face-to-face interview method.
On postoperative day 0, all patients will be verbally informed by the ward nurses about the standard guidelines and care to be followed after spinal surgery after admission to the ward.
Patients in the control group will not receive any intervention to quench thirst. The questions in the postoperative patient follow-up form will be asked by the researcher and the postoperative patient follow-up form will be filled out.
After the standard care of the service is applied to the patients in the experimental group, the patients will be evaluated by the researcher nurse with the "Safe Protocol in the Management of Thirst in the Early Postoperative Period" in the 2nd postoperative hour after admission to the service. The postoperative patient follow-up form will be applied to patients with appropriate criteria. Saliva pH will be evaluated before the first set. Afterwards, 0.5 ml of oral cold water spray kept in the 40C service refrigerator will be applied. Thirty minutes later, 0.5 ml of oral cold water spray which has been kept in the 40C service refrigerator will be applied for the second time. The first set will be completed. In the third hour, the severity of thirst and discomfort due to thirst will be evaluated with the chart in the postoperative patient follow-up form. In the fourth hour, 0.5 ml oral cold water spray kept in the 40C service refrigerator will be applied. Thirty minutes later, 0.5 ml of oral cold water spray kept in the 40C service refrigerator will be applied again. The second set will be completed. In the fifth hour, the severity of thirst and discomfort due to thirst and saliva Ph will be evaluated with the chart in the postoperative patient follow-up form. In addition, patients' satisfaction with oral cold water spray application will be evaluated. Data collection will end after the completion of the questionnaire applications.
- Conditions
- Thirst
- Being tested
- Oral cold spray (tap water)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral cold spray (tap water)Other
Oral cold spray (tap water)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in the experimental group will receive oral cold spray (tap water) in the postoperative period. Receives: Other: Oral cold spray (tap water) |
| Control group | No intervention | Patients in the control group will not be intervened in the postoperative period except for standard care for thirst management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
thirst
to determine the effect of oral cold water spray application on the severity of thirst after spinal surgery.
Thirst severity and discomfort levels of the patients will be evaluated numerically four times and salivary pH levels will be evaluated twice (before the first application and 1 hour after the end of all applications) with the chart (Visual Analogue Scale values) at the end of the "Postoperative patient follow-up form". The Visual Analogue Scale, which is used to convert data that cannot be evaluated numerically into numerical form, is 10 cm long and is graded on a horizontal or vertical line. Since thirst is a state of discomfort consisting of subjective experiences expressed by the person, it is stated in the literature that the use of the Visual Analogue Scale in the evaluation of thirst is appropriate and can be used safely in studies.
Measured: postoperative period (2., 2.5, 4. and 4.5. hours)
Secondary outcomes (1)
satisfaction of patients
to determine the effect of oral cold water spray application on patient satisfaction after spinal surgery.
Patient satisfaction form; The satisfaction of the patients in the experimental group with the oral cold water spray application will be evaluated with a numerical rating scale ranging from 0 to 10 points (0 = I am not satisfied at all, 10 = I am very satisfied).
Measured: postoperative period (6.hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Dec 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the experimental group will receive oral cold spray in the postoperative period. Patients in the control group will receive standard care in the postoperative period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Kızılcık Ozkan, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171347
- Sponsor's protocol ID
- 2023/349
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Cold Water Spray Application on Thirst Severity in Patients Undergoing Spinal Surgery: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06171347
- Acronym / sponsor ID
- 2023/349
- Conditions
- Thirst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 14 Dec 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.
The aim of this study was to determine the effect of oral cold water spray application on thirst severity and patient satisfaction after spinal surgery.
H1: Oral cold water spray application has an effect on thirst severity after spinal surgery.
H2: Oral cold water spray application has an effect on salivary pH after spinal surgery.
H3: Oral cold water spray application affects the satisfaction of patients after spinal surgery.
Detailed description
The randomized controlled trial will be conducted in the brain and neurosurgery service of Trakya University Health Research and Application Centre. Date of research will be conducted between December 2023 and March 2024. The research sample will consist of 62 volunteer patients. The sample was determined using power analysis at the research planning stage. The minimum number of people to be included in the sample was calculated as 62, each group consisting of 31 (1:1) patients, with an effect size of 0.75, 95% confidence level, 5% tolerance and 80% power ratio, using the G.Power 3.1.9.4 program. Data Collection Forms Patient information form; The form was developed by the researchers in line with the literature and consisted of 9 questions inquiring information about age, gender, educational status, height, body weight, marital status, habits, physician diagnosis, presence of chronic diseases, etc.
ostoperative patient follow-up form; There are 11 questions in the form. The answers to the first 9 questions will be obtained by interviewing the patient face to face. The eleventh question (type of fluid taken during surgery) and the answer to the twelfth question (amount of bleeding during surgery) will be obtained from the anaesthesia transfer form.
The severity of thirst and discomfort levels of the patients will be evaluated numerically four times and saliva pH levels will be evaluated twice (before the first application and 1 hour after the end of the whole application) with the chart at the end of the form (Visual Analogue Scale values). The Visual Analogue Scale, which is used to convert data that cannot be evaluated numerically into numerical form, is 10 cm long and is graded on a horizontal or vertical line. Since thirst is a state of discomfort consisting of subjective experiences expressed by the person, it is stated in the literature that the use of the Visual Analogue Scale in the evaluation of thirst is appropriate and can be used safely in studies. The scale includes 2 questions evaluating the severity of thirst and the severity of discomfort from thirst numerically between 0-10. Patient satisfaction form; The satisfaction of the patients in the experimental group with the oral cold water spray application will be evaluated with a numerical rating scale ranging from 0 to 10 points (0 = I am not satisfied at all, 10 = I am very satisfied).
Data collection process Patients who meet the inclusion criteria will be informed verbally and in writing about the study, scales, etc. in the preoperative period and the informed consent form will be signed. "Patient Information Form" will be applied in the preoperative period. The data of the study will be collected by the researcher in the patient room by face-to-face interview method.
On postoperative day 0, all patients will be verbally informed by the ward nurses about the standard guidelines and care to be followed after spinal surgery after admission to the ward.
Patients in the control group will not receive any intervention to quench thirst. The questions in the postoperative patient follow-up form will be asked by the researcher and the postoperative patient follow-up form will be filled out.
After the standard care of the service is applied to the patients in the experimental group, the patients will be evaluated by the researcher nurse with the "Safe Protocol in the Management of Thirst in the Early Postoperative Period" in the 2nd postoperative hour after admission to the service. The postoperative patient follow-up form will be applied to patients with appropriate criteria. Saliva pH will be evaluated before the first set. Afterwards, 0.5 ml of oral cold water spray kept in the 40C service refrigerator will be applied. Thirty minutes later, 0.5 ml of oral cold water spray which has been kept in the 40C service refrigerator will be applied for the second time. The first set will be completed. In the third hour, the severity of thirst and discomfort due to thirst will be evaluated with the chart in the postoperative patient follow-up form. In the fourth hour, 0.5 ml oral cold water spray kept in the 40C service refrigerator will be applied. Thirty minutes later, 0.5 ml of oral cold water spray kept in the 40C service refrigerator will be applied again. The second set will be completed. In the fifth hour, the severity of thirst and discomfort due to thirst and saliva Ph will be evaluated with the chart in the postoperative patient follow-up form. In addition, patients' satisfaction with oral cold water spray application will be evaluated. Data collection will end after the completion of the questionnaire applications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients in the experimental group will receive oral cold spray in the postoperative period. Patients in the control group will receive standard care in the postoperative period.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Oral cold spray (tap water)Patients in the experimental group will receive oral cold spray (tap water) in the postoperative period. |
| Control group | No intervention | –Patients in the control group will not be intervened in the postoperative period except for standard care for thirst management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Inpatient treatment in the neurosurgery ward,
- undergoing planned spinal surgery under general anaesthesia,
- Admitted to the ward after surgery,
- Who volunteered to participate in the research,
- No mental disability,
Key exclusion criteria (9 listed)
- Spinal surgery performed under spinal anaesthesia,
- Admitted to intensive care or external ward after surgery,
- Emergency surgery,
- not volunteering to participate in the research,
- Mentally handicapped,
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 |
|---|---|---|
| Oral cold spray (tap water)Oral cold spray (tap water) | Other | Experimental group |
Primary outcome
thirst
Time frame: postoperative period (2., 2.5, 4. and 4.5. hours)
to determine the effect of oral cold water spray application on the severity of thirst after spinal surgery. Thirst severity and discomfort levels of the patients will be evaluated numerically four times and salivary pH levels will be evaluated twice (before the first application and 1 hour after the end of all applications) with the chart (Visual Analogue Scale values) at the end of the "Postoperative patient follow-up form". The Visual Analogue Scale, which is used to convert data that cannot be evaluated numerically into numerical form, is 10 cm long and is graded on a horizontal or vertical line. Since thirst is a state of discomfort consisting of subjective experiences expressed by the person, it is stated in the literature that the use of the Visual Analogue Scale in the evaluation of thirst is appropriate and can be used safely in studies.
1 secondary outcome
satisfaction of patients
Time frame: postoperative period (6.hour)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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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.
Emine KOÇ contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral cold spray (tap water) in people with Thirst, run by Trakya 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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZEYNEP KIZILCIK ÖZKAN (+905056010101, zeynepkizilcik26@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thirst (time frame: postoperative period (2., 2.5, 4. and 4.5. hours)). 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 14 Dec 2023.