Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery
Primary Purpose
Xerostomia, Thirst
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cold water spray application
cold saline spray application
Sponsored by
About this trial
This is an interventional supportive care trial for Xerostomia focused on measuring mouth dryness, thirst, saliva, oral health, major abdominal surgery, randomized controlled health
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Gulhane Education and Training Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
cold water spray group
cold saline spray group
control group
Arm Description
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.
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.
no intervention
Outcomes
Primary Outcome Measures
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.
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.
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.
oral condition
The Oral Health Assessment Tool were used. As the score on the scale increases, the oral condition worsens.
Secondary Outcome Measures
patient satisfaction assessed by the VAS
VAS will be used, numbered between 0-10, 0: not satisfied at all, 10: very satisfied.
Full Information
NCT ID
NCT04657913
First Posted
September 28, 2020
Last Updated
December 7, 2020
Sponsor
Ankara Medipol University
1. Study Identification
Unique Protocol Identification Number
NCT04657913
Brief Title
Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery
Official Title
The Effect of Spray Use on Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Medipol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Thirst
Keywords
mouth dryness, thirst, saliva, oral health, major abdominal surgery, randomized controlled health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cold water spray group
Arm Type
Experimental
Arm Description
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.
Arm Title
cold saline spray group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Other
Intervention Name(s)
cold water spray application
Other Intervention Name(s)
cold water spray
Intervention Description
It will be sprayed into the mouth of patients every hour.
Intervention Type
Other
Intervention Name(s)
cold saline spray application
Other Intervention Name(s)
cold saline spray
Intervention Description
It will be sprayed into the mouth of patients every hour.
Primary Outcome Measure Information:
Title
mouth dryness severity
Description
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.
Time Frame
Evaluation was made in the first 48 hours after surgery
Title
thirst severity
Description
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.
Time Frame
Evaluation was made in the first 48 hours after surgery
Title
saliva PH
Description
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.
Time Frame
Evaluation was made in the first 48 hours after surgery
Title
oral condition
Description
The Oral Health Assessment Tool were used. As the score on the scale increases, the oral condition worsens.
Time Frame
Evaluation was made in the first 48 hours after surgery
Secondary Outcome Measure Information:
Title
patient satisfaction assessed by the VAS
Description
VAS will be used, numbered between 0-10, 0: not satisfied at all, 10: very satisfied.
Time Frame
It were evaluated at 48th hours postoperatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bediye Oztas, Phd
Organizational Affiliation
Ankara Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Education and Training Hospital
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
35153118
Citation
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.
Results Reference
derived
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Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery
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