Determining the effect of cold water spray on thirst distress, dry mouth and fluid consumption in patients with heart failure
Design
Clinical trial with a control group, with parallel groups, without blinding, randomized, on 68 patients. For randomization, random blocks of four were used through Random Allocation software.
Settings and conduct
The environment of this research was the CCU and heart departments of Imam Reza and Qaim hospitals. Imam Reza hospital includes five CCUs and a heart department, which has a total of 66 active beds, Qaim hospital also has two CCUs and two cardiac departments.
Participants/Inclusion and exclusion criteria
Heart failure patients hospitalized in the CCU and heart departments of Imam Reza and Qaim hospitals in Mashhad/
1- with a diagnosis of heart failure
2- Having limited fluids
3- Age 18 to 65 years
4- At most 24 hours have passed since hospitalization
5- Willingness to participate in the study
6- Not suffering from hearing and speech defects
7- Consciousness
8- Not suffering from psychological diseases
9- Thirst distress scale score above 8
Exclusion criteria:
1- Non-cooperation in the study
2- Failure to fill in the questionnaire
3- Discharge/death of the patient
Intervention groups
Intervention / exposure / main outcome group:
Heart failure patients hospitalized in the CCU and heart departments of Imam Reza and Qaim hospitals in Mashhad / cold water spray program / reducing the distress of thirst, dry mouth and fluid consumption
Control group(s) (placebo, no placebo):
Heart failure patients hospitalized in the CCU and heart departments of Imam Reza and Qaim hospitals in Mashhad / department routine
Main outcome variables
Thirst distress, dry mouth, fluid intake
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221229056977N1
Registration date:2023-03-16, 1401/12/25
Registration timing:registered_while_recruiting
Last update:2023-03-16, 1401/12/25
Update count:0
Registration date
2023-03-16, 1401/12/25
Registrant information
Name
Amir Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3386 5932
Email address
ghasemia4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2023-05-10, 1402/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cold water spray on thirst distress and dry mouth and Fluid intake in patients with Heart failure
Public title
The effect of cold water spray on thirst distress and dry mouth and Fluid intake in patients with Heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- Diagnosed with heart failure
2- Having limited liquids
3- Age 18 to 65 years
4- At most 24 hours have passed since hospitalization
5- Willingness to participate in the study
6- Not suffering from hearing and speech defects
7- Consciousness
8- Not suffering from psychological diseases
9- Thirst distress scale score above 8
Exclusion criteria:
1- Non-cooperation in the study
2- Failure to fill in the questionnaire
3- Discharge/death of the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Blocked
Random blocks of four through Random Allocation software
Allocation concealment method: a closed envelope is used, in such a way that the random sequence generated is printed on cards and stored in the same order inside the closed envelope, whenever a person is found eligible to enter the study, the envelope is opened. and a card is given to him face to face and he is assigned to one of the intervention or control groups based on the card code.
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
Research Ethics Committee of Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, University of Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-02-28, 1401/12/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.115
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Thirst distress
Timepoint
Before the start of the intervention, before each implementation of the cold water spray intervention, the end of the intervention
Method of measurement
Thirst distress scale for heart failure patients, numerical rating scale
2
Description
dry mouth
Timepoint
Before the start of the intervention, before each implementation of the cold water spray intervention, the end of the intervention
Method of measurement
Challacombe scale, numerical rating scale
3
Description
Fluid intake
Timepoint
Before the intervention, 24 hours later, 48 hours later, 72 hours later
Method of measurement
Checklist for registration of consumed liquids
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The cold water spray program will be implemented 6 times a day every two hours from 9 am to 5 pm for 3 days by the research team. The spray intervention includes different parts of the patient's mouth (upper jaw, lower jaw, left cheek, right cheek and tongue) every time. The water spray is kept in the refrigerator in the department at a temperature of 2 to 8 degrees Celsius.
Category
Prevention
2
Description
Control group: In the control group, the routine method includes wetting the lips when the patient complains of thirst.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Educational, Research and Treatment Center
Full name of responsible person
amir ghasemi
Street address
Ibn Sina St., Imam Reza Educational Research and Treatment Center, Mashhad, Razavi, Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
2
Recruitment center
Name of recruitment center
Qaim educational, research and treatment center
Full name of responsible person
amir ghasemi
Street address
Qaim Hospital, Ahmedabad St., Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor
Street address
University Street, Qurashi Building, Research and Technology Vice-Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
amir ghasemi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 28, 8 Shahid Khani, 37 Shahid Daei Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9163844488
Phone
+98 51 3386 5932
Email
ghasemia4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Ghasemi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 28, 8 Shahid Khani, 37 Shahid Daei Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9163844488
Phone
+98 51 3386 5932
Email
ghasemia4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
amir ghasemi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 28, 8 Shahid Khani, 37 Shahid Daei Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9163844488
Phone
+98 51 3386 5932
Email
ghasemia4001@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available