The study will be conducted on 100 female bachelor nursing students of Tabriz University of medical sciences. Sampling is available and it is done in the dormitory. The allocation of 2 groups (intervention and control) is randomly. After taking confirmation from ethics committee and student's written consent, before the intervention, the rate of their anxiety and sleep quality will be evaluated. In the case of having anxiety using anxiety questionnaire and sleep problems using sleep quality questionnaire, they will be located in one of control or intervention groups. In the intervention group, aromatherapy will be done for 2 weeks (14 nights) using essential oil of Citrus Aurantium. The subjects inhale 4-5 drops of pure essential oil of Citrus Aurantium that are trickled on some cotton in a box. The box is placed at a distance of 6-9 cm from the student's nose and they inhale it for 14 nights and 15 minutes per night. The duration of inhalation step is 2 weeks and after that, the rate of anxiety and sleep quality will be evaluated again. Such intervention will not be done in the control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070223525N5
Registration date:2016-08-12, 1395/05/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-12, 1395/05/22
Registrant information
Name
Hossein Namdar Areshtanab
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
namdarh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences and Health Services
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Citrous Aurantiun Aromatherapy on Sleep Quality and Anxiety Among Female Nursing Students, A Randomized Clinical Trial
Public title
The Effect of Citrus Aurantiun Aromatherapy on Sleep Quality and Anxiety Among Female Nursing Students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: nursing bachelor student living in dormitory; willingness to cooperate in the study; completing and signing informed consent form; having olfactory health; obtaining scores of 40 and above, according to Spiel Berger anxiety form; obtaining scores of 5 and above, according to Peters Burg sleep quality questionnaire; no history of mental illness, depression and acute stress (like crises such as the loss of relatives and family members); not coinciding the study with final exams.
Exclusion criteria: the students who do not like to continue their cooperation for any reason; the students who feel discomfort with the smell of essential oil of Citrus aurantium; the students who use perfume; the students working at teaching hospitals in night shift continuously; the students who use anti-anxiety drugs, hypnotic drugs, and herbal medicines during the intervention.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golghasht Ave.
City
Tabriz
Postal code
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
TBZMED.REC.1395.266
Health conditions studied
1
Description of health condition studied
Sleep Quality, Anxiety
ICD-10 code
G47.8
ICD-10 code description
Other sleep disorders
Primary outcomes
1
Description
Sleep Quality
Timepoint
Before intervention, two weeks after intervention
Method of measurement
Peters Burg sleep quality questionnaire
Secondary outcomes
1
Description
Anxiety
Timepoint
Before intervention, two weeks after intervention
Method of measurement
Spiel Berger anxiety questionnaire
Intervention groups
1
Description
In the intervention group, aromatherapy will be done for 2 weeks (14 nights) using essential oil of Citrus aurantium. The subjects inhale 4-5 drops of pure essential oil of Citrus aurantium that are trickled on some cotton in a box. The box is placed at a distance of 6-9 cm from the student's nose and they inhale it for 14 nights and 15 minutes per night. The duration of inhalation step is 2 weeks and after that, the rate of anxiety and sleep quality will be evaluated again.
Category
Treatment - Other
2
Description
Control group:The intervention will not be done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Hossein Namdar Areshtanab
Street address
South Shariati Ave, Nursing and Midwifery Faculty
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Gholghasht Ave, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences and Health Services
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
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Sareh Shamsipor
Position
Masters student
Other areas of specialty/work
Street address
South Shariati Ave, Nursing and Midwifery Faculty
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
sarehshamsipour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Hossein Namdar Areshtanab
Position
Phd in nursing education
Other areas of specialty/work
Street address
South Shariati Ave, Nursing and Midwifery Faculty
City
Tabriz
Postal code
5138947977
Phone
+98 41 3470 6770
Fax
+98 41 3479 6969
Email
namdarh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Hossein Namdar Areshtanab
Position
Phd in nursing education
Other areas of specialty/work
Street address
South Shariati Ave, Nursing and Midwifery Faculty
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
namdarh@tbzmed.ac
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)