Comparison of the effect of mouthwash with cold water, menthol and psyllium ovata on the relief of thirst and dry mouth in patients admitted to intensive care units
Design
Initially, patients who are eligible for the study will be asked if they have a thirst and dry mouth. If their thirst is above 3, they will be included in the study. Then, in one of the groups, cold water will be used with menthol and in the other group of the Psyllium. the intervention will last for a maximum of 15 minutes by the researcher in both groups and will be repeated again 30 minutes later.
Settings and conduct
Medical and surgical intensive care units of Shariati and Imam Khomeini hospitals will form the environment of this study. The intervention will take up to 15 minutes for patients, and intervention will repeat again after at least 30 minutes. Before and after each intervention, the intensity and distress of thirst and mouth dry will be evaluated. The routine interrogation is performed using cotton swabs and chlorhexidine. The control group will receive only routine interventions.Both intervention groups will receive the routine care also.
Participants/Inclusion and exclusion criteria
Age over 18, 24 hours of admission; Ability to understand Persian language; Awareness of time, place and person; Satisfaction to participate in the study; Non-admission of opioids and narcotics ; Richmond criteria between negative one to one; Not having a history of allergy; Thirst more than 3
Intervention groups
Cool water with Menthol: Cold water plus menthol to wash mouth and tongue and menthol to moisturize.
plantago ovata (Esfarzah): To wash mouths and tongues, and to wet the lips
Control group: Rutin ICU interference with chlorhexidine
Main outcome variables
Thirst intensity ؛ Thirst distress؛ Dry mouth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170803035479N2
Registration date:2018-11-08, 1397/08/17
Registration timing:registered_while_recruiting
Last update:2018-11-08, 1397/08/17
Update count:0
Registration date
2018-11-08, 1397/08/17
Registrant information
Name
Leila Sayadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4322
Email address
l-sayadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of cold water with mentol and plantago ovata oral care on thirst and dry mouth in intensive care unit patients
Public title
Comparingcold water with mentol and plantago ovata on thirst and dry mouth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
At least 24 hours passed since their admission to the ICU
Be able to understand Persian speak and have the ability to read
Orientation to time، place and person
Willingness to participate in study
Do not received drugs such as opioids which suppress the consciousness
Richmond criteria between -1 to +1.
No history of allergies
No history of allergy to the pessilium powder
Thirst score more than 3
Exclusion criteria:
Having a open mouth lesions or lips lesions, mouth or lip mucous destroy
History of dementia or Alzheimer، interaction of medical condition (like oral surgery) with study intervention
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
In order to balance the number of samples assigned to each of the treatments in 4 intensive care units, permutation block randomization will be used. Based on this method, we assign randomly the number of patients in each block under the intervention of menthol ، plantago psyllium or control. With the help of this intervention allocation method, at the end, the number of patients is equally treated differently and different treatments are equally tested in different parts.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, intervention and data collection will be done by researcher. There will be no possibility to blind researcher, so only participants and statistician will not be aware of the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional research ethics committee school of nursing and midwifery & rehabilitation
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Approval date
2018-09-04, 1397/06/13
Ethics committee reference number
IR.TUMS.FNM.REC.1397.108
Health conditions studied
1
Description of health condition studied
Thirst and dry mouth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Thirst intensity: Those patients whose thirst scores are greater than three based on numeric rating scales.
Timepoint
Before intervention, immediately after mouth washing for the first time, and also after second mouth washing (30 minutes after first one)
Method of measurement
Numeric rating scales
2
Description
Dry mouth : patient’s dryness feeling of lips and mouth
Timepoint
Before mouth washing, after mouth washing for the first time, and also after second mouth washing (30 minutes after first one)
Method of measurement
Patient Self-declaration
3
Description
Distress of Thirst: Feeling sick of thirst
Timepoint
Before intervention, after mouth washing for the first time, and also after second mouth washing (30 minutes after first one)
Method of measurement
Numeric rating scales
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group (cold water with menthol): Oral washing (mouthwash/ oral care) with cold water and menthol is performed in a two-step process in the morning or evening shift. So that for a maximum of 15 minutes, cold water will be rubbed by the researcher to the lips, tongue and mucus Patients' mouths. and the lips of patients will also be moisturized using menthol. At least 30 minutes later, the washings will be repeated with cold water and menthol. Menthol is prepared with a percentage of 0.1 by pharmacist professors from traditional medicine (this will dilute the mint essence in the base of the water). Cool water is used at a temperature of 15-7 ° C for washing the mouth and tongue, and menthol only will use for moisturizing the lips. The menthol is provided with preservatives will last an average of two months in the refrigerator.
Category
Treatment - Other
2
Description
The second intervention group (the plantagu ovata/ Esfarzah): The oral washing is done in a two-step process in the morning or evening shift. The prepared solution will last for up to 15 minutes by the researcher on the lips, tongue and oral mucosa of the patients. After 30 minutes, this intervention will be repeated again (The prepared solution will be used both for washing the mouth and tongue, and for wetting the lids). The plantagu ovata solution is sprayed at consentration of 0.2 grams (two tenths of gram) in 100 cc of water. The solution will have a preservative that will allow storage in the refrigerator for up to two months. It should be noted that the temperature of the solution is similar to cold water , and both (cold water and Esfarzeh Solution)will have the same temperature. For the preparation of Plantagu ovata, the powder of the outer part of the psyllium, which is available at the pharmacy (for the removal of constipation), will be used.
Category
Treatment - Other
3
Description
Control group: A group that only receives routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital,Tehran University of Medical Sciences
Imam Khomeini Hospital , Dr Gharib St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Fax
+98 21 6658 1615
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc2.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohamad Ali Sahraeiyan
Street address
Tehran University of Medical Sciences Office of Vice-Chancellor for Global Strategies and International Affairs, Number 21, Dameshgh St., Vali-e Asr Ave.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3619
Email
nmcrc@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Elnaz Nasiri
Position
MS Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4325
Email
eli1992nasiri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
leila Sayadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4322
Email
l-sayadi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Sayadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4322
Email
l-sayadi@sina.tums.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