Objective: Determine the effect of aromatherapy with bitter orange extract on sleep quality in patients with type 2 diabetes. The study was parallel randomized clinical trial Inclusion criteria 1.Suffering from type 2 diabetes 2.Age between 30 to 65 years 3.No history of mental disease 4. No history of allergy and Asthma 5-Having sufficient strength of odor olfactory 6. Do not use sedative7. No history of diabetic foot ulcers 8.Lack of experience stressful events during the 3 months ago 9.Lack of pregnancy, breast feeding and hot flushing 10-not having night work. Exclusion criteria 1. The unwillingness of patients to continue to cooperate 2- discharge from the hospital during the study 3. The incidence of symptoms such as shortness of breath and hives 4. stressful events during study. The sample size was calculated as 30 in each group. Richard champble sleep questionnaire before test was completed in both group.Researcher used 8 drop bitter orange extract 20% (Made in Hegrat company in Kashan) in consecutive three night in experimental group at 22 night and asked from patient to throw out it in the morning. recompleted questionnaire end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011520145N4
Registration date:2017-03-09, 1395/12/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-09, 1395/12/19
Registrant information
Name
Fatima Mohaddes Ardebili
Name of organization / entity
Iran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
mohaddes.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Aromatherapy with Bitter orange extract on Sleep quality in Patient with type 2 diabetic
Public title
Effect of Aromatherapy on sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Suffering from type 2 diabetes according to medical records 2-Age between 30 to 65 years 3. No history of mental disorder 4. No history of respiratory allergies, asthma, allergic rhinitis and sensitivity to plant material according to patient express 5-Having sufficient strength of odor olfactory 6. Do not use sleeping pills, sedatives drugs, contraceptives and antimigraine drug 7. No history of diabetic foot ulcers due to its impact on sleep quality 8-Lack of experience stressful events during 3 months ago (such as divorce, death, marriage and etc) 9.Lake of pregnancy, breast feeding and hot flushing 10- Not having night worke Exclusion criteria 1. The unwillingness of patients to continue to cooperate 2- discharge from the hospital during the study 3. The incidence of symptoms such as shortness of breath and hives 4. stressful events during study
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Medical wards were randomly divided into interventional and control groups. then for the homogenization of environmental conditions intervention and control environment changed every week.The one of two paper which was written the names of control and interventional was taken and each of medical wards placed in one of two group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sience
Street address
HEMMAT HIGH WAY NEXT TO THE MILLAD TOWER
City
TEHRAN
Postal code
1449614535
Approval date
2016-05-28, 1395/03/08
Ethics committee reference number
IR.IUMS.REC1395.9311686017
Health conditions studied
1
Description of health condition studied
DIABETES DISEASE
ICD-10 code
IV
ICD-10 code description
E10,E14
Primary outcomes
1
Description
sleep quality
Timepoint
Before the intervention and at the end of study.
Method of measurement
Richard Campbell Sleep Quality questionaire
Secondary outcomes
1
Description
Do not have
Timepoint
Do not have
Method of measurement
Do not have
Intervention groups
1
Description
One intervention (experimental group) :8 Drop bitter orange extract 20% (Made in Hegrat Company in Kashan) at three consecutive night in inhalled.
Category
Other
2
Description
Two intervention (Control group): Receive routine care and performed no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu ali hospital
Full name of responsible person
Amir mohammad kazemifar
Street address
Cross road Bu ali, Qazvin
City
Qazvin
2
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Karami aliakbar
Street address
Taavon Square, 22 Boulevard, Minudar, Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Iran University of Medical Sciences
Full name of responsible person
Mosavi Seyed Aligavad
Street address
Vice Chancellor for Research Iran University of Medical Science, Hemmat Highway, Next to the Milad Tower, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology Iran University of Medical Sciences
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
Iran Univercity of Medical Science
Full name of responsible person
Fariba Abdollahi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shahid Yassemi Street, Mir Damad Street, Vali Asr Street, Tehran
City
Tehran
Postal code
iran
Phone
+98 21 8888 2885
Fax
Email
faribaabdollahi93@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Mohaddes Ardebili
Position
Master in Nursing Education
Other areas of specialty/work
Street address
Shahid Yassemi Street, Mir Damad Street, Vali Asr Street, Tehran
City
Tehran
Postal code
Tehran
Phone
+98 21 8877 3072
Fax
Email
mohaddes.f@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba abdollahi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shahid Yassami Street, MirDamad Street, Vali Asr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
faribaabdollahi93@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)