Main goal:Assessment of Lippia Citriodoras Oil effect on Sleep Disorder versus ineffective Oil
Design and Method: The statistical population of this study is all people over 60 years old with sleep disorder in elders of care centers of Tehran. This study is a randomized, double-blind clinical trial. Before randomization, the eligibility criteria will be checked by gathering the information about the disease and drugs of elders, recorded and examined according to their medical records and then questions asked from elders who have used drugs affecting on sleep disorders about having sleep-related problems. Then the study and details of intervention will be explained by the interviewer, and the patients will enter to the study after signing the informed consent. Patients will be assigned to the intervention and control groups based on Balanced Block Randomization. In the control group two drops ineffective oil and in the intervention group two drops Lemon verbena Oil will be administered in the nose morning and night. Basic information, including Pittsburgh Sleep Quality, and Demographic questionnaire will be asked in the beginning, 2 and 4 weeks after starting the medications. Patients will be asked for probable complications. Main outcomes: improving subjective quality of sleep and increasing sleep efficiency. Since the Lemon verbena medicine has scent and Placebo is scentless, for blinding intervention and control patients, the drugs are put near each other in order to take Lemon verbena smell and also a little amount of Lemon verbena oil will be sprayed on the medicine container.
General information
Acronym
insomnia
IRCT registration information
IRCT registration number:IRCT2016061528485N1
Registration date:2016-12-23, 1395/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-23, 1395/10/03
Registrant information
Name
seyran mohamadi bolban abad
Name of organization / entity
University of Rehabilitation Sciences and Social Welfare
Country
Iran (Islamic Republic of)
Phone
+98 918 667 5708
Email address
se.mohamadi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Aging Research Center, University of Social Welfare and Rehabilitation
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Lippia Citriodora effect on Sleep DisorderversusOilineffective:
A double blind study
Public title
Assessment of Lippia Citriodora effect on Sleep DisorderversusOilineffective:
A double blind study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria (inclusion):
Tendency to participate in the study؛ Having over 60 years old؛ Having sleep disorders, in self-reported, or clinical level, and according to the Pittsburgh questionnaire؛ Ability of respond to the questionnaire؛ No history of any allergy, to lemon verbena, or mangroves plants؛ No continuous using from (twice or more in per week) from lemon Herbal Tea, or lemon extract over 1 month ago؛ No problems with the airway and nasal obstruction
Exclusion criteria (exclusion):
Having dependence or addiction to alcohol , drugs and medicines؛ Having disease, like that heart failure, respiratory disorders, and diseases of sleep, and wake-up cycle such as, respiratory apnea, and restless leg syndrome؛ Using from Effective drugs, on the sleep and wake up cycle (except previous prescribed drugs )
Age
From 60 years old to 90 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
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Rehabilitation Sciences and Social Welfare
Street address
koodakyar deadlock Boulevard student Evin field Tehran
City
Tehran
Postal code
1985713834
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
IR.USWR.REC.1395.50
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
Improve sleep quality
Timepoint
Intervention. Two weeks after starting treatment and after the treatment (4 weeks after the intervention)
Method of measurement
questionnaire
Secondary outcomes
1
Description
Improve sleep Subjective quality
Timepoint
Early intervention. 2 weeks after starting intervention and 4week after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
In the control group using vegetable oils in lemon and control groups using inert oil (liquid paraffin)
Category
Placebo
2
Description
dropping two drops of inert oil in the nose morning and night
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kahrizak Charity Foundation in tehran
Full name of responsible person
Street address
Kahrizak, the end of the boulevard Doctor Hakim zadeh. Qom old road after Bhsht zahra, Tehran,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Welfare and Rehabilitation Research Center
Full name of responsible person
Robab Sahaf
Street address
Kodakyar deadlock Boulevard student Evin field . Welfare and Rehabilitation Sciences University / Center for Aging Research. Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Welfare and Rehabilitation Research Center
Proportion provided by this source
100
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
University of Welfare and Rehabilitation Research Center
Full name of responsible person
Seyran mohamadi bolban abad
Position
MSc Student of Gerontology, University of Social Welfare and Rehabilitation Sciences
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0154
Fax
Email
mohammadi162@yahoo.com se.mohamadi@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Welfare and Rehabilitation Research Center
Full name of responsible person
Robab Sahaf
Position
PHD Gernotology
Other areas of specialty/work
Street address
Welfare and Rehabilitation Sciences University / Center for Aging Research. Koodakyar street. Boulevard student . Evin. Tehran
City
Tehran
Postal code
Phone
+98 21 2218 0154
Fax
Email
robabsahaf@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Rehabilitation Sciences and Social Welfare
Full name of responsible person
ْSeyran mohamadi bolban abad
Position
MSc Student of Gerontology, University of Social Welfare and Rehabilitation Sciences
Other areas of specialty/work
Street address
Department of Aging. koodakyar street. Boulevard student. Evin. Tehran.
City
Tehran
Postal code
Phone
00
Fax
Email
mohammadi162@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)