XerostomiaNCT04657913
Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery
A study testing cold water spray application and cold saline spray application in people with Xerostomia and Thirst, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine the effects of spray use on dry mouth and thirst of patients who had undergone major abdominal surgery. The methods used to alleviate the thirst and dry mouth experienced by patients undergoing major abdominal surgery are limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Thirst
- What is being tested?
- cold water spray application and cold saline spray application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 31 Jan 2021
- 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
- patients who underwent major abdominal surgery under general anesthesia (due to lower and upper gastrointestinal tract malignancy)
- patients without oral and nasal disease
- patients who do not have vision, hearing, speech and understanding problems
- patients with American Society of Anesthesiologists (ASA) I and II scores
- patients over the age of 18
Who cannot join
- patients whose mouth and tongue mucosa integrity was degraded
- patients had a cognitive disorder
- patients had a neurological, renal, cardiac or pulmonary disorders that could affect the test results
- patients using psychoactive drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Education and Training Hospital
Ankara
About this study
Official title: The Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery: A Randomized Controlled Study
The purpose of this study is to determine the effects of spray use on dry mouth and thirst of patients who had undergone major abdominal surgery. The methods used to alleviate the thirst and dry mouth experienced by patients undergoing major abdominal surgery are limited. This research was conducted as a randomized controlled trial.
Read the detailed description
The study sample includes patients who had undergone major abdominal surgery induced by upper or lower gastrointestinal system malignancies. The patients who met the inclusion criteria were informed about the purpose of the study and were invited to the study. Those who accepted to participate in the study were included in the study.
Patients who had undergone major abdominal surgery with general anesthesia (induced by upper or lower gastrointestinal system malignancies), who do not have any oral and nasal diseases, who do not have visual, hearing, speech and understanding problems, who were in the American Society of Anesthesiologists (ASA) I and II grades, who were aged 18 or over and agreed to participate in the study were included.
Patients whose mouth and tongue mucosa integrity was degraded, who had a cognitive disorder, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results, or who use psychoactive drugs were excluded.
The standard anesthesia protocol was implemented to all patients suitable for the study. In the postoperative period, the standard rational dose antibiotic therapy (1st generation cephalosporin + metronidazole), metoclopramide HCL, NSAIDs, LMWH, N-acetylcysteine (NAC), H2-receptor blockers (ranitidine HCL), pethidine HCL 50 mg/ml, when required, and maintenance fluid therapy (Combination of normal saline, lactated Ringer's and Dextrose) by their weight were administered to the patients.
First Control Group: No intervention was performed on the patients in the control group. To prevent ethical violations, patients received routine clinical practice (a small amount of water was administered orally, using a syringe).
Second Intervention Group: Cold water kept at +40 C in the refrigerator was added into 50cc spray-head bottles and administered to patients orally in the postoperative phase, by spraying twice hourly.
Third intervention Group: Cold normal saline (0.9% NaCl) kept at +40 C in the refrigerator was added into 50cc spray-head bottles and administered to patients orally in the postoperative phase, by spraying twice hourly.
No intervention was performed on patients from midnight thru 06:00 AM, in order not to disturb the circadian rhythms of all patients.
Considering surgery end time and circadian rhythms of patients, the data of the patients were recorded at the post-operative 4, 8, 20, 24, 36, 40th hours. The flow chart of the study is shown in Figure 1. In the cold water and cold normal saline applications, 50cc glass bottles, plastic spray head, and cover were used. New material was used for each patient.
Preoperative measurements: Patients' data such as age, gender, comorbid diseases, ASA (American Society of Anesthesiologists) grade, diagnosis, preoperative thirst intensity, preoperative mouth dryness intensity, preoperative oral health condition were recorded.
Outcome measurements Postoperative evaluations were made after the interventions. Intensity of Thirst: VAS with a range of 0-10 points (0: mild, 10 very severe) was used while the thirsty severity of all patients were evaluated.
Intensity of Mouth Dryness: VAS with a range of 0-10 points (0: never experiencing mouth dryness, 10: experiencing very intense mouth dryness) was used while the mouth dryness severity of all patients were evaluated.
Oral Health Condition: To assess patients' oral health condition, the Oral Health Assessment Tool (OHAT) was used. The first four items of the scale that assess lips, tongue, gums and tissue, and saliva were used. The lowest score to be obtained from the scale is 0, while the highest score is 8 (0=healthy; 1=changes; 2=unhealthy). A higher OHAT score indicates a poor oral condition.
Saliva PH: To measure the PH of saliva, the patient's saliva sample in a sterile container was assessed using PH test strips.
Patient Satisfaction: To evaluate patient satisfaction, overall satisfaction was scored using a 10-point numerical rating scale (NRS) from 0 (complete dissatisfaction) to 10 (complete satisfaction).
At the postoperative 4th hour, the severity of thirst and dry mouth, oral health status and saliva PH values were evaluated in terms of differences between the groups.
At the postoperative 8th hour, the severity of thirst and dry mouth, oral health status and saliva PH values were evaluated in terms of differences between the groups.
At the postoperative 20,24,36 and 40th hour, the severity of thirst and dry mouth, oral health status and saliva PH values were evaluated in terms of differences between the groups.
- Conditions
- Xerostomia, Thirst
- Being tested
- cold water spray application, cold saline spray application
- Keywords
- mouth dryness, thirst, saliva, oral health, major abdominal surgery, randomized controlled health
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold water spray applicationOther
Also called cold water spray
It will be sprayed into the mouth of patients every hour.
cold saline spray applicationOther
Also called cold saline spray
It will be sprayed into the mouth of patients every hour.
| Study group | Role | What they receive |
|---|---|---|
| cold water spray group | Experimental | application of cold water in the form of a spray to mouth of patients will be applied 2 times per hour, starting 2 hours after the end of the operation. Receives: Other: cold water spray application |
| cold saline spray group | Experimental | application of cold 0.9% SF (saline) in the form of a spray to mouth of patients will be applied 2 times per hour, starting 2 hours after the end of the operation. Receives: Other: cold saline spray application |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
mouth dryness severity
Numbered between 0-10 0: no dry mouth 10: very severe dry mouth Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.
Measured: Evaluation was made in the first 48 hours after surgery
thirst severity
Numbered between 0-10 0: no thirsty 10: very severe thirsty Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.
Measured: Evaluation was made in the first 48 hours after surgery
saliva PH
To measure the pH value, the patient's saliva sample were taken and simple PH test sticks were used and the PH value were determined according to the color changes on the PH test stick.
Measured: Evaluation was made in the first 48 hours after surgery
oral condition
The Oral Health Assessment Tool were used. As the score on the scale increases, the oral condition worsens.
Measured: Evaluation was made in the first 48 hours after surgery
Secondary outcomes (1)
patient satisfaction assessed by the VAS
VAS will be used, numbered between 0-10, 0: not satisfied at all, 10: very satisfied.
Measured: It were evaluated at 48th hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies 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
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bediye Oztas, Ankara Medipol University
- Investigators
- Bediye Oztas, Phd, Principal investigator, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657913
- Sponsor's protocol ID
- Ankara Medipol University
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oztas M, Oztas B. Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):214-220. doi: 10.1016/j.jopan.2021.04.018. Epub 2022 Feb 10.
PubMed 35153118
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04657913
- Acronym / sponsor ID
- Ankara Medipol University
- Conditions
- Xerostomia, Thirst
- Keywords
- mouth dryness, thirst, saliva, oral health, major abdominal surgery, randomized controlled health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 8 Dec 2020 (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 purpose of this study is to determine the effects of spray use on dry mouth and thirst of patients who had undergone major abdominal surgery. The methods used to alleviate the thirst and dry mouth experienced by patients undergoing major abdominal surgery are limited. This research was conducted as a randomized controlled trial.
Detailed description
The study sample includes patients who had undergone major abdominal surgery induced by upper or lower gastrointestinal system malignancies. The patients who met the inclusion criteria were informed about the purpose of the study and were invited to the study. Those who accepted to participate in the study were included in the study.
Patients who had undergone major abdominal surgery with general anesthesia (induced by upper or lower gastrointestinal system malignancies), who do not have any oral and nasal diseases, who do not have visual, hearing, speech and understanding problems, who were in the American Society of Anesthesiologists (ASA) I and II grades, who were aged 18 or over and agreed to participate in the study were included.
Patients whose mouth and tongue mucosa integrity was degraded, who had a cognitive disorder, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results, or who use psychoactive drugs were excluded.
The standard anesthesia protocol was implemented to all patients suitable for the study. In the postoperative period, the standard rational dose antibiotic therapy (1st generation cephalosporin + metronidazole), metoclopramide HCL, NSAIDs, LMWH, N-acetylcysteine (NAC), H2-receptor blockers (ranitidine HCL), pethidine HCL 50 mg/ml, when required, and maintenance fluid therapy (Combination of normal saline, lactated Ringer's and Dextrose) by their weight were administered to the patients.
First Control Group: No intervention was performed on the patients in the control group. To prevent ethical violations, patients received routine clinical practice (a small amount of water was administered orally, using a syringe).
Second Intervention Group: Cold water kept at +40 C in the refrigerator was added into 50cc spray-head bottles and administered to patients orally in the postoperative phase, by spraying twice hourly.
Third intervention Group: Cold normal saline (0.9% NaCl) kept at +40 C in the refrigerator was added into 50cc spray-head bottles and administered to patients orally in the postoperative phase, by spraying twice hourly.
No intervention was performed on patients from midnight thru 06:00 AM, in order not to disturb the circadian rhythms of all patients.
Considering surgery end time and circadian rhythms of patients, the data of the patients were recorded at the post-operative 4, 8, 20, 24, 36, 40th hours. The flow chart of the study is shown in Figure 1. In the cold water and cold normal saline applications, 50cc glass bottles, plastic spray head, and cover were used. New material was used for each patient.
Preoperative measurements: Patients' data such as age, gender, comorbid diseases, ASA (American Society of Anesthesiologists) grade, diagnosis, preoperative thirst intensity, preoperative mouth dryness intensity, preoperative oral health condition were recorded.
Outcome measurements Postoperative evaluations were made after the interventions. Intensity of Thirst: VAS with a range of 0-10 points (0: mild, 10 very severe) was used while the thirsty severity of all patients were evaluated.
Intensity of Mouth Dryness: VAS with a range of 0-10 points (0: never experiencing mouth dryness, 10: experiencing very intense mouth dryness) was used while the mouth dryness severity of all patients were evaluated.
Oral Health Condition: To assess patients' oral health condition, the Oral Health Assessment Tool (OHAT) was used. The first four items of the scale that assess lips, tongue, gums and tissue, and saliva were used. The lowest score to be obtained from the scale is 0, while the highest score is 8 (0=healthy; 1=changes; 2=unhealthy). A higher OHAT score indicates a poor oral condition.
Saliva PH: To measure the PH of saliva, the patient's saliva sample in a sterile container was assessed using PH test strips.
Patient Satisfaction: To evaluate patient satisfaction, overall satisfaction was scored using a 10-point numerical rating scale (NRS) from 0 (complete dissatisfaction) to 10 (complete satisfaction).
At the postoperative 4th hour, the severity of thirst and dry mouth, oral health status and saliva PH values were evaluated in terms of differences between the groups.
At the postoperative 8th hour, the severity of thirst and dry mouth, oral health status and saliva PH values were evaluated in terms of differences between the groups.
At the postoperative 20,24,36 and 40th hour, the severity of thirst and dry mouth, oral health status and saliva PH values were evaluated in terms of differences between the groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cold water spray group | Experimental | Other: cold water spray applicationapplication of cold water in the form of a spray to mouth of patients will be applied 2 times per hour, starting 2 hours after the end of the operation. |
| cold saline spray group | Experimental | Other: cold saline spray applicationapplication of cold 0.9% SF (saline) in the form of a spray to mouth of patients will be applied 2 times per hour, starting 2 hours after the end of the operation. |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients who underwent major abdominal surgery under general anesthesia (due to lower and upper gastrointestinal tract malignancy)
- patients without oral and nasal disease
- patients who do not have vision, hearing, speech and understanding problems
- patients with American Society of Anesthesiologists (ASA) I and II scores
- patients over the age of 18
Key exclusion criteria (4 listed)
- patients whose mouth and tongue mucosa integrity was degraded
- patients had a cognitive disorder
- patients had a neurological, renal, cardiac or pulmonary disorders that could affect the test results
- patients using psychoactive drugs
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 |
|---|---|---|
| cold water spray applicationAlso: cold water sprayIt will be sprayed into the mouth of patients every hour. | Other | cold water spray group |
| cold saline spray applicationAlso: cold saline sprayIt will be sprayed into the mouth of patients every hour. | Other | cold saline spray group |
Primary outcome
mouth dryness severity
Time frame: Evaluation was made in the first 48 hours after surgery
Numbered between 0-10 0: no dry mouth 10: very severe dry mouth Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.
thirst severity
Time frame: Evaluation was made in the first 48 hours after surgery
Numbered between 0-10 0: no thirsty 10: very severe thirsty Numerical rating scale (1-3 mild, 4-6 moderate, 7-10 severe) were used.
saliva PH
Time frame: Evaluation was made in the first 48 hours after surgery
To measure the pH value, the patient's saliva sample were taken and simple PH test sticks were used and the PH value were determined according to the color changes on the PH test stick.
oral condition
Time frame: Evaluation was made in the first 48 hours after surgery
The Oral Health Assessment Tool were used. As the score on the scale increases, the oral condition worsens.
1 secondary outcome
patient satisfaction assessed by the VAS
Time frame: It were evaluated at 48th hours postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Derived from this study: PubMed 35153118Oztas M, Oztas B. Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):214-220. doi: 10.1016/j.jopan.2021.04.018. Epub 2022 Feb 10.
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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.
Bediye Oztas, Phd principal investigator
Ankara Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold water spray application and cold saline spray application in people with Xerostomia and Thirst, run by Ankara Medipol 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 5 inclusion and 4 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 8 Dec 2020. 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?
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?
mouth dryness severity (time frame: Evaluation was made in the first 48 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04657913, which also lists 1 linked publication.
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 8 Dec 2020.