Comparison of the effect of aromatherapy with essence of Rosa Damascena and Bitter Orange (Citrus aurantium ) Blossom on symptoms of premenstrual syndrome in students of Shiraz University, 2015
This study is a RCT in which compare the effect of aromatherapy with essence of Rosa Damascena and Bitter Orange (Citrus aurantium ) Blossom on symptoms of premenstrual syndrome in students of Shiraz University of Medical Sciences, in 2015. Study will be done on 99 students that randomly divided into three groups of 33 students. After screening and determination of students that have premenstrual syndrome in the intervention groups inhalation of rose essence and Bitter Orange blossom essence and in the control group inhalation of almond oil will be done. Subjects of three groups receive bottles ( 5 ml for a month) of Rose,Bitter Orange Blossom or Almond oil. Aromatherapy done a week before menstruation for 5 days ( 5 minute × 2 daily) for two consecutive cycles, each subject is instructed to decant the 10 drops of essence onto an eye pad, sit in a stable and comfortable place, position the pad 30 cm away from nose, and inhale the fragrance for 5 minutes with normal breathing. Then in menstrual period students complete the PSST questionnaire and will survey the effect of intervention on PMS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031113940N3
Registration date:2016-03-15, 1394/12/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-15, 1394/12/25
Registrant information
Name
Marzieh Akbarzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
akbarzadm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of aromatherapy with essence of Rosa Damascena and Bitter Orange (Citrus aurantium ) Blossom on symptoms of premenstrual syndrome in students of Shiraz University, 2015
Public title
Comparison of the effect of aromatherapy with essence of Rose and Bitter Orange Blossom on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Willingness for participation; 2-Not using supplement; 3-Not using hormonal pills from 2 months before intervention; 4-Length of menstrual cycle between 24-35 days; 5-Not having disease like DM and psychologic disease; 6-Filling informed testimonial, GHQ and PSST questionnaire.
Exclusion criteria: 1- Willingness for leaving the study; 2-Occurence of accident for participant in the phase of study;3-Length of menstrual cycle lower than 24 days or more than 35 days;4-Length of menstrual period lower than 3 days or more than 7 days;5- Stress event in recent 3 years like surgery or marriage;6-Using any medication in the time of study; 6- Allergy to essences.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
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
Shiraz University of Medical Sciences
Street address
Zand Blvd
City
Shiraz
Postal code
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
Ir.sums.rec.1394.163
Health conditions studied
1
Description of health condition studied
premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
premenstural syndrome screening
Timepoint
before and after mensturation
Method of measurement
PSST Questionnaire
Secondary outcomes
1
Description
Psychologic health
Timepoint
before intervention
Method of measurement
GHQ
Intervention groups
1
Description
Intervention group: Aromatherapy will be done a week before menstruation for 5 days ( 5 minute × 2 daily) for two consecutive cycles, each subject is instructed to decant the 10 drops of essence onto an eye pad, sit in a stable and comfortable place, position the pad 30 cm away from nose, and inhale the fragrance for 5 minutes with normal breathing. Dose of Rose essence is 4% and Bitter orange essence is 0.5%.
Control group:Like intervention group but by almond oil.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences dormitories
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Vice chancellor of research of university
Street address
Zand Blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Naval Heydari
Position
MSc. of Nursing/Instructor
Other areas of specialty/work
Street address
Namazi Square-School of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
navalheydari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
MSc. of Midwifery/Instructor
Other areas of specialty/work
Street address
Namazi square-School of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
akbarzadm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
MSc. of Midwifery/ Instructor
Other areas of specialty/work
Street address
Namazi Square- School of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
akbarzadm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)