Comparison of the effects of inhalation aromatherapy with rose and lavender and odorless sesame seed oil and Musk willow on postpartum depression in women at risk: a clinical trial
This study aims to examine the effect of aromatherapy with damask rose & lavender on postpartum depression in women at risk. This research is a double-blind clinical trial conducted on 105 pregnant women in 35th -37th week of pregnancy who will attend two health care center, affiliated to Yazd University of Medical Sciences. After getting informed consent from pregnant women who meets the inclusion criteria, HADS and Edinburgh questionnaire will be completed and pregnant women will be excluded from the study if they give score 13 and above from Edinburg questionnaire score 11 or above from each component of HADS questionnaire. Pregnant women will randomly be categorize into three groups of intervention and control. The intervention is Intervention group: inhaling 7 drops of lavender essential oil with 1 cc of Rosewater with a concentration of 100%, produced by the Barij Company, 10 times before sleeping, from 38th week of gestational age until six weeks after delivery. In placebo group this process will be followed: inhaling 7 drops of sesame seed oil with 1 cc of Musk willow with a concentration of 100%, produced by the Barij Company, 10 times before sleeping, from 38th week of gestational age until six weeks after delivery. Control group will receive routine care. Then 2 and 6 weeks after delivery , the degree of depression will be measured by Edinberg scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080929281N1
Registration date:2017-01-03, 1395/10/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-03, 1395/10/14
Registrant information
Name
Fateme Moshirenia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3521 9358
Email address
f.moshirenia@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Isfahan University of Medical Sciences
Expected recruitment start date
2015-06-20, 1394/03/30
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of inhalation aromatherapy with rose and lavender and odorless sesame seed oil and Musk willow on postpartum depression in women at risk: a clinical trial
Public title
The effect of aromatherapy on postpartum depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: being literate; having Iranian nationality; No abnormalities in infant According to Ultrasound exam; no drugs or alcohol consumption by the mother; mother not being affected by known chronic or systemic diseases; no consumption of anti depressant or anti anxiety medications in recent pregnancy; no history of asthma, allergy, or dermatitis diagnosed by a physician; no history of eczema and allergy to flowers and plants diagnosed by a physician; Not having perceived social support from the side of family and friends for current pregnancy; Unwanted pregnancy; Unemployed husband; having Stressful life events in the last 12 months before delivery
Exclusion criteria: allergy to lavender and rose essential in the subjects or their family members.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The three groups before and after the three-step test plan
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Azadi Sq, Hezar Garib Ave, Isfahan, Iran
City
Isfahan
Postal code
8174673461
Approval date
2013-12-16, 1392/09/25
Ethics committee reference number
394408
Health conditions studied
1
Description of health condition studied
Postpartum Depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Postpartum Depression.
Timepoint
Before the intervention, two weeks after giving birth and six week.ks after giving birth
Method of measurement
Edinburgh questionnaire.
Secondary outcomes
1
Description
_
Timepoint
_
Method of measurement
_
Intervention groups
1
Description
Intervention group: inhaling 7 drops of lavender essential oil with 1 cc of Rosewater with a concentration of 100%, produced by the Barij Company, 10 times before sleeping, from 38th week of gestational age until six weeks after delivery
Category
Treatment - Drugs
2
Description
Placebo group: inhaling 7 drops of sesame seed oil with 1 cc of Musk willow with a concentration of 100%, produced by the Barij Company, 10 times before sleeping, from 38th week of gestational age until six weeks after delivery
Category
Treatment - Drugs
3
Description
Control group: they receive routine care.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirjalily Center
Full name of responsible person
Miss Rangbar
Street address
Health Center of Shahid Mirjalili, Anar Sq, Shohadah Ave, Shahediyah, Yazd, Iran
City
Yazd
2
Recruitment center
Name of recruitment center
Taleghany Center
Full name of responsible person
Miss Asayesh
Street address
Health Center of Shahid Taleghani, Basig Sq, Maglesi Ave, Zarg, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Maryam kianpour
Street address
Esfahan University of Medical Sciences, Azadi Sq, Hezar Garib Ave, Isfahan, Iran
City
Esfahan
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,Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Fateme Moshirenia
Position
Master student of Midwifery
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Azadi Sq, Hezar Garib Ave, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 35 3521 9358
Fax
_
Email
f.moshirenia@gmail.com
Web page address
_
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fateme Moshirenia
Position
MS student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Azadi Sq, Hezar Garib Ave, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 35 3521 9358
Fax
Email
f.moshirenia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fateme Moshirenia
Position
Master student of Midwifery
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Azadi Sq, Hezar Garib Ave, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 35 3521 1698
Fax
Email
f.moshirenia@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)