The aim of this trail is to determine the impact of aromatherapy on the quality of sleep and anxiety in postpartum women. The study is a randomized clinical trial. 140 eligible women in 3-5 days after delivery randomly will be allocated into an intervention and a control group (placebo).Mothers randomly assign to intervention group inhale Lavender aroma four sessions per week for eight weeks. The process of aromatherapy explains for mothers and Lavender oil will dropped on a piece of cotton pad placed in a small box and mothers are asked to take 10 deep breath first before sleep and then put it near their pillow, within 20 cm distance from themselves. The control group does the same process with placebo instead. All subjects will fill Pittsburgh Sleep Quality Index (PSQI) at baseline (3-5 days after delivery) and 4 and 8 week after initiation of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211179463N8
Registration date:2013-09-08, 1392/06/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-08, 1392/06/17
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of aromatherapy on the quality of sleep in postpartum women
Public title
The impact of aromatherapy on the quality of sleep in postpartum women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Having a singleton live child 2-Literate 3-Uncomplicated vaginal delivery 4-Aged 18 to 35 5-without known physical, mental and psychological illness. 6-Exlusive breast feeding 7-Healthy baby 8-Acquiring Pittsburgh Sleep Quality Index score of 5 or higher
Exclusive criteria:1-Appearance of physical and psychological illness during study. 2-Using certainmedications(such as hypnotics or sedatives) 3-Allergies to the herbs 4-Having depression
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Tehran University of Medical Science
Street address
Tehran-Bolvar Keshavarz near Ghods street-centeral building-6th floor
City
Tehran
Postal code
Approval date
2013-08-04, 1392/05/13
Ethics committee reference number
130/904/د/92
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
O94,O99
ICD-10 code description
Other Obstetric Conditions, Not elsewhere classified
Primary outcomes
1
Description
sleep quality
Timepoint
before intervention-4 and 8 weeks after initiation of intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:the participants will drop lavender oil on a piece of cotton pad placed in a small box before sleep take 10 deep breath and then put it near their pillow, within 20 cm distance from themselves. This process continues for 8 weeks, 4 times a week.
Category
Treatment - Drugs
2
Description
control group(placebo): the participants will drop placebo on a piece of cotton pad placed in a small box before sleep take 10 deep breath and then put it near their pillow, within 20 cm distance from themselves. This process continues for 8 weeks, 4 times a week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan health center number 9
Full name of responsible person
Dr Behboodi Moghadam Zahra
Street address
Zanjan health center number 9-fateh street-Zanjan
City
Zanjan
2
Recruitment center
Name of recruitment center
Zanjan Health center number 14
Full name of responsible person
Dr Behboodi Moghadam Zahra
Street address
Zanjan Health center number 14-shahrak karmandan street-Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science research
Full name of responsible person
Dr Fotoohi Akbar
Street address
Tehran- keshavarz_ghods street-centeral building of Tehran University of Medical Science
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science research
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
tehran university of medical science
Full name of responsible person
Dr Behboodi Moghadam Zahra
Position
phd
Other areas of specialty/work
Street address
Tohid Square-faculty of Nursing & Midwifery tehran university of medical science
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
Bahar_behboodi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Behboodi Moghadam Zahra
Position
phd
Other areas of specialty/work
Street address
Tohid Square-faculty of Nursing & Midwifery tehran university of medical science
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
Bahar_behboodi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of medical science
Full name of responsible person
Keshavarz Afshar Mahnaz
Position
MA
Other areas of specialty/work
Street address
City
Zanjan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)