Comparison of the effect of salivary gland massage and water spray on thirst and xerostomia before surgery in patients undergoing cardiac surgery
Design
This study was performed on 120 patients who were randomly assigned to two intervention groups and one control group using RANDBETWEEN method in Excel software.
Settings and conduct
Patients are candidates for heart surgery in Afshar Hospital in Yazd. 120 patients with inclusion criteria are randomly assigned to three groups.
At seven o'clock in the morning, a questionnaire is completed for all three study groups.
For the control group, the questionnaire is completed again one hour later. In the salivary gland massage group, after teaching how to massage, the patient performs the massage process for 3 minutes if he feels thirsty and dry mouth, and an questionnaire is completed again one hour later. In the water spray group, in case of thirst or dry mouth Moisten all the mucous surfaces of the mouth with water spray and then one hour later, the questionnaire is completed again.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Candidate patients for heart surgery
Thirst score and dry mouth one or higher using the visual thirst scale
Exclusion criteria:
Sugar more than 126 mg per deciliter in the morning of operation
Chronic dry mouth
Taking anticholinergic drugs, antihistamines, tricyclic antidepressants
Existence of any sores, inflammation or pests in the mouth
Intervention groups
Salivary gland massage intervention group
Water spray intervention group
Control group
Main outcome variables
Thirst, Xerostomia ,Thirst tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210628051732N1
Registration date:2021-12-29, 1400/10/08
Registration timing:prospective
Last update:2021-12-29, 1400/10/08
Update count:0
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Seyed Tahereh Hosseini Mortazavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3521 4939
Email address
hosseini.mortazavi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of salivary gland massage and water spray on Thirst and Xerostomia before heart surgery
Public title
Effect of salivary gland massage and water spray on Thirst and Xerostomia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients Candidate for cardiac surgery
Age range between 15 to 70 years
Thirst and dry mouth score one or more using the visual scale
Willingness to participate in the study
Exclusion criteria:
Heart failure (EF less than 35%)
Glucose greater than 126 mg / dL on the morning of surgery
Chronic dry mouth
Dialysis patients
Use of anticholinergic drugs, antihistamines, tricyclic antidepressants
Tobacco and alcohol abuse
Existence of any sores, inflammation or pests in the mouth
Candidates for emergency heart surgery
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 120 patients who meet the inclusion criteria are selected as a research sample and using the RANDBETWEEN method in Excel software are randomly assigned to two intervention groups and a control group (40 people in each group). .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8917945556
Approval date
2021-03-21, 1400/01/01
Ethics committee reference number
IR.SSU.REC.1399.042
Health conditions studied
1
Description of health condition studied
Thirst
ICD-10 code
T73.1
ICD-10 code description
Deprivation of water
2
Description of health condition studied
Xerostomia
ICD-10 code
k11.7
ICD-10 code description
disturbances of salivary secretion
Primary outcomes
1
Description
Thirst
Timepoint
7 o'clock in the morning on operation day and one hour after
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Xerostomia
Timepoint
7 o'clock in the morning on operation day and one hour after
Method of measurement
Visual Analogue Scale (VAS)
3
Description
Tolerance to thirst and dry mouth
Timepoint
7 o'clock in the morning on operation day and one hour after
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the first intervention group, the massage is performed 4 times. The duration of each massage is 3 minutes and it is repeated every 15 minutes.
Category
Rehabilitation
2
Description
Intervention group: For the second group of intervention, water spray at room temperature is used. The volume of water consumed is 70 ml. Water spray is used every 15 minutes.
Category
Rehabilitation
3
Description
Control group: No intervention is performed for the control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital, Yazd
Full name of responsible person
Mohamad Hassan Abdoalahi
Street address
Islamic Republic Boulevard, Yazd
City
Yazd
Province
Yazd
Postal code
89179455556
Phone
+98 35 3525 5011
Email
Afsharhospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mostafa Javadi
Street address
Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3724 0171
Email
Afshrhospital@ssu.ac.ir
Web page address
https://web.ssu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyede Tahere Hosseini Mortazavi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 17, Imam Street, Shahdieh
City
Yazd
Province
Yazd
Postal code
8943118881
Phone
+98 35 3521 4939
Email
hosseini.mortazavi96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mostafa Javadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
BooAli Blvd, Nursing And MidWifery School
City
Yazd
Province
Yazd
Postal code
89431188881
Phone
+98 35 3824 1751
Email
javadinurse@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyede Tahere Hosseini Mortazavi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 173, Imam Street, Shahdieh
City
Yazd
Province
Yazd
Postal code
8943118881
Phone
+98 35 3521 4939
Email
hosseini.mortazavi96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The publication of the results will be in accordance with the principle of fiduciary duty and the principle of anonymity of human samples. The general results will be published in the article.
When the data will become available and for how long
Two years
To whom data/document is available
Thesis supervisor, statistical consultant and all researchers at the request and discretion of the dissertation supervisor
Under which criteria data/document could be used
Do similar studies, apply the results in the clinic
From where data/document is obtainable
Scientific responsible for the study
What processes are involved for a request to access data/document
The request will be answered by email within two weeks