Objectives: Identify the effect of oral moisturizing gel containing aloe vera and peppermint oil on Xerostomia and Mucosal-Plaque in intensive care unit patients Design: a triple blind randomized clinical trial. Setting and conduct: The eligible patients who will admitted to intensive care unit of Amin Hospital during the study period will be enrolled into the trial. Inclusion criteria: age range of 18–65 years; no chronic disease; being intubated during the study period ; Less than 12 hours Intensive care unit length of stay . Exclusion criteria: being discharged from ICU; patient’s death; Intervention group: Using topical oral moisturizing gel containing aloe vera and peppermint oil twice a daily( Every 12 hours) apply 10 gr for 7 days. Control group: Using topical placebo twice a daily( Every 12 hours) apply 10 gr for 7 days
Primary outcome: Assessing xerostomia before and after treatment through Challacombe Scale and Assessing mucosal-plaque formation before and after treatment through mucosal-plaque Score. Secondary outcome: Assessing local reactions such as hives, or redness after treatment through physical examination. Randomization: The patients will be randomly assigned to intervention and control groups using block randomization. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120331200N1
Registration date:2017-02-03, 1395/11/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-03, 1395/11/15
Registrant information
Name
Vajihe Atashi
Name of organization / entity
Nursing Faculty of Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
vajiheatashi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral moisturizing gel containing aloe vera and peppermint oil on Xerostomia and Mucosal-Plaque in intubate patients in ICU
Public title
The effect of oral moisturizing gel on dry and mucous plaque formation in intubated patients admitted to a special section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:age range of 18–65 years؛ no chronic disease؛ being intubated during the study period؛ Less than 12 hours Intensive care unit length of stay
exclusion criteria:being discharged from ICU؛ patient’s death
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan, Iran,
City
Isfahan
Postal code
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.MUI.REC.1395.2.141
Health conditions studied
1
Description of health condition studied
Xerostomia and Mucosal-Plaque in intubate patients in ICU
ICD-10 code
K00-K93
ICD-10 code description
Diseases of oral cavity, salivary glands and jaws
Primary outcomes
1
Description
Xerostomia
Timepoint
before and after
Method of measurement
Challacombe Scale
2
Description
Mucosal-Plaque
Timepoint
before and after
Method of measurement
mucosal-plaque index
Secondary outcomes
1
Description
Assessing local reactions such as hives, or redness
Timepoint
after treatment
Method of measurement
through physical examination
Intervention groups
1
Description
Intervention group: Using topical oral moisturizing gel containing aloe vera and peppermint oil twice a daily( Every 12 hours) apply 10 gr for 7 days
Category
Treatment - Drugs
2
Description
Control group: Using topical placebo twice a daily( Every 12 hours) apply 10 gr for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Vajihe Atashi
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave, Isfahan, IR Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Nursing and Midwifery Research Center
Street address
Nursing and Midwifery Research Center, Nursing and Midwifery school, Isfahan University of Medical Science
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Barij Essence Company
Full name of responsible person
Dr Reza Bekhradi
Street address
mashhad ardehal, kashan
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery school
Full name of responsible person
Vajihe Atashi
Position
Nursing PhD Student
Other areas of specialty/work
Street address
Nursing and Midwifery school, Isfahan University of Medical Science, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 314390115
Fax
Email
vajiheatashi@nm.mui.ac.irvajiheatashi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery School
Full name of responsible person
Vajihe Atashi
Position
Nursing PhD Student
Other areas of specialty/work
Street address
Nursing and Midwifery School, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 314390115
Fax
Email
vajiheatashi@nm.mui.ac.irvajiheatashi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery school
Full name of responsible person
Vajihe Atashi
Position
Nursing PhD Student
Other areas of specialty/work
Street address
Nursing and Midwifery school, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 314390115
Fax
Email
vajiheatashi@nm.mui.ac.irvajiheatashi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)