The goal of this study is determining aromatherapy with Rosa damascene on sleep quality of children with sleep disorder. Inclusion criteria: age at diagnosis of 12-5 years with complaint's of sleep disorder; No having allergy, asthma, atopic dermatitis, Nasal health; Not taking any medication or sleep inducing action; No other underlying disease drug consumption with effect on sleep Exclusion criteria: Outside the range specified age; Having allergic diseases; Nasal disorders; Using that affects on sleep.The sample size is 30.After entering children and recording data and filling BEARS questionnaire,they use aromatherapy before sleeping in 20 minutes and after 2 weeks will reevaluate.
Evaluation based on changes in sleep onset problems, excessive daytime sleepiness, waking up during the night, order and long sleep and snoring done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062222865N1
Registration date:2015-07-12, 1394/04/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-12, 1394/04/21
Registrant information
Name
Armaghan Sadat Keyhanmehr
Name of organization / entity
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
keyhanmehr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences,school of traditional medicine
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with “Rosa Damascena” on sleep quality of children with sleep disorder
Public title
The effect of aromatherapy with Rosa Damascena on sleep quality of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age at diagnosis of 12-5 years with complaint's of sleep disorder; No having allergy, asthma, atopic dermatitis, Nasal health; Not taking any medication or sleep inducing action; No other underlying disease drug consumption with effect on sleep
Exclusion criteria:Outside the range specified age; Having allergic diseases; Nasal disorders; Using that affects on sleep
Age
From 5 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti university of medical science
Street address
Chamran high way-Velenjak ave
City
Tehran
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
171
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
onset sleep disorders
Timepoint
before intervention-after two weeks
Method of measurement
questionnaire
2
Description
Excessive daytime sleepiness
Timepoint
before intervention-after two weeks
Method of measurement
questionnaire
3
Description
Waking up during the night
Timepoint
before intervention-after two weeks
Method of measurement
questionnaire
4
Description
Length of time in order to sleep
Timepoint
before intervention-after two weeks
Method of measurement
questionnaire
5
Description
snoring
Timepoint
before intervetion-after two weeks
Method of measurement
questionnaire
Secondary outcomes
1
Description
sneezing
Timepoint
before and after intervention
Method of measurement
questionnaire
2
Description
cough
Timepoint
before and after intervention
Method of measurement
questionnaire
3
Description
other symptoms
Timepoint
before and after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
drop of Rosa damascene, 10%,5 drops, nights in 20 minutes before bedtime for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Me
Full name of responsible person
Armaghan Keyhanmehr
Street address
8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave.,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Me
Full name of responsible person
sommaye esmaili
Street address
8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Me
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
a Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of
Full name of responsible person
Armaghan Sadat Keyhanmehr
Position
student of traditional medicinephd
Other areas of specialty/work
Street address
8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave.,
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
a_keyhanmehr@yahoo.comar.keyhanmehr@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
a Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of
Full name of responsible person
Mina Movahhed
Position
assistant professor
Other areas of specialty/work
Street address
8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave.,
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
m_movahhed@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
a Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of
Full name of responsible person
Armaghan Sadat Keyhanmehr
Position
student of traditional medicine-phd
Other areas of specialty/work
Street address
8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave.,
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
a_keyhanmehr@yahoo.comar.keyhanmehr@gmail.cim
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)