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Investigating the effect of implementing a thirst relief program on the thirst in intensive care unit patients

Protocol summary

Study aim
Determining the effect of the implementation of the thirst relief program on the level of thirst of intensive care units patients
Design
This clinical trial has a control group with parallel groups without blinding, with random allocation of samples to groups, which will be conducted on 82 patients hospitalized in special departments. Random allocation will be done using the random sequence generated by the randomization site (www.randomization.com)
Settings and conduct
This clinical trial study without blinding will be conducted on 82 patients of the special care department in Qaim (AS) and Imam Reza (AS) hospitals in Mashhad. During one day from 8:00 am to 8:00 pm in eligible patients, after performing oral care according to the patient's needs, the thirst relief pack includes firstly using a wet swab, then cold water spray (below 4 degrees Celsius) and finally using menthol. (0.1%) will be applied on the lips and every two hours the patient's thirst will be measured with a numerical scale and a thirst scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 and 65 years, Richmond score between +1 - 1, no ulceration in the mouth and lips, being NPO and at least 24 hours stays in the intensive care unit. exclusion criteria: failure to continue cooperation, the occurrence of problems in communication, severe deterioration of the patient
Intervention groups
During one day from 8:00 am to 8:00 pm in eligible patients, after performing oral care according to the patient's needs, the thirst relief pack includes firstly using a wet swab, then cold water spray (below 4 degrees Celsius) and finally using menthol. (0.1%) will be applied on the lips and every two hours, the patient's thirst will be measured with the Numeric and TDS.
Main outcome variables
Thirst intensity; Thirst distress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220728055572N1
Registration date: 2022-10-04, 1401/07/12
Registration timing: registered_while_recruiting

Last update: 2022-10-04, 1401/07/12
Update count: 0
Registration date
2022-10-04, 1401/07/12
Registrant information
Name
zohreh Rajabzadeh tavil
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2606
Email address
zrajabzadez2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-11, 1401/06/20
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of implementing a thirst relief program on the thirst in intensive care unit patients
Public title
The effect of implementing a thirst relief program on the thirst in intensive care unit patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Proficiency in Persian language Age between 18 and 65 years Having a score of +1 - 1- from the Richmond Irritability-Sedation Scale At least 24 hours of stay in the intensive care unit and 48 hours stay in the ward Not having a history of mental problems according to family members Absence of surgery and wounds in the mouth and lips (based on the oral health form (bedside oral exam) no fluid intake by mouth
Exclusion criteria:
Unwillingness to continue cooperation in conducting research at any stage Changing the patient's state of consciousness so that she is unable to communicate. The occurrence of severe respiratory or hemodynamic disorder so that the patient is unable to continue participating in the study. Any obstacle that causes a delay in the intervention (conducting diagnostic tests outside the department, etc.)
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: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Closed envelopes: will be placed in closed envelopes after random allocation, and after selecting the research sample, it will come out of the envelope in the allocation package and the individual will be placed in the intervention or control 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
Research Ethics committee of Mashhad University of Medical Sciences
Street address
Nursing & Midwifery School. Ebnesina Ave., Daneshgah Blvd., mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-06-11, 1401/03/21
Ethics committee reference number
IR.MUMS.REC.1401.123

Health conditions studied

1

Description of health condition studied
Thirst of patients hospitalized in the intensive care unit
ICD-10 code
R68.2
ICD-10 code description
Dry mouth, unspecified

Primary outcomes

1

Description
Thirst intensity score based on Namrik criteria
Timepoint
from 8 to 20 every two hours (8-10-12-14-16-18-20)
Method of measurement
- Numerical scale (0-10) to measure the intensity of thirst

2

Description
Thirst distress score obtained from the Thirst Distress Scale- Heart Failure
Timepoint
from 8 to 20 every two hours (8-10-12-14-16-18-20)
Method of measurement
Using the Thirst Distress Scale-Heart Failure tool

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group of the thirst relief program will be implemented. The components of this program are that during one day, from 8:00 am to 8:00 pm, the thirst relief program will be implemented in such a way that at 8:00 am and also at 2:00 pm using the form (bedside oral health exam) Examination of the need for mouthwash and care and necessary measures will be implemented according to the patient's condition and related to thirst and oral hygiene (such as mouthwash) and then from 8:00 am to 8:00 pm every 2 hours, severity and distress Thirst will be evaluated using the Namrik criterion, and if it has a score of 3 or more, the thirst relief pack includes the use of a wet swab first, then cold water spray (below 4 degrees Celsius) and finally the use of menthol (0.1%) on the lips (that the whole intervention will last approximately 5 minutes will be implemented. Also, placing wet gauze on the patient's teeth will be used throughout the study for both control and intervention groups.
Category
Other

2

Description
Control group: At 8:00 am and also at 2:00 pm using the form (Bedside oral exam, oral health examination will be performed to determine the need for mouthwash and the necessary care and care for the patient's condition and related to thirst and oral hygiene (such as mouthwash). and then from 8:00 am to 8:00 pm every 2 hours, the intensity and speed of thirst will be evaluated using the evaluation criteria, and if it has a score of 3 or more, it will be given to care and care will be taken, also from Placing gas in the labia of the patient's teeth will be used throughout the study for both control and intervention groups.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mahmoud Mohammadzadeh Shabestri
Street address
Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Web page address
https://emamreza.mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr. Gholamali Mamouri
Street address
Ahmedabad St
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2465
Email
b.ghaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Hajiabadi
Street address
Nursing & Midwifery School. Ebnesina Ave., Daneshgah Blvd., mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Web page address
https://nurse.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
Fatemeh Hajiabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery School. Ebnesina Ave., Daneshgah Blvd., mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
hajiabadif@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Hajiabadi
Position
Head of Mashhad School of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
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
Phone
+98 51 3859 1511
Email
hajiabadif@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Hajiabadi
Position
assiatant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
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
Phone
+98 51 3859 1511
Email
hajiabadif@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
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
There is currently no plan to publish this data
When the data will become available and for how long
The possibility of accessing the data one year after the end of sampling will be published in the article resulting from the study in approximately 18 months.
To whom data/document is available
The data will be published in the article and will not be for a specific group and will not be presented individually
Under which criteria data/document could be used
The data will be published in the article and will not be for a specific group and will not be presented individually
From where data/document is obtainable
The data will be published in the article and will not be for a specific group and will not be presented individually
What processes are involved for a request to access data/document
The data will be published in the article and will not be for a specific group and will not be presented individually
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