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Comparison of the effects of orange Essential oil and omega 3 in prevention of postpartum depression

Protocol summary

Study aim
effect of Orange and Omega-3 on prevention of postpartumdepression
Design
This is a three-group randomized controlled trial of 150 women in the postpartum period . The selection of study participants is done based on the inclusion criteria and they receive necessary information about the goals and research protocols. Finally, they are randomly divided into three groups: "the aromatherapy", "the omega-3 supplementation" group and the "control" group.
Settings and conduct
At first, all participants complete the Edinburgh Depression Questionnaire. if their score are below 12, they complete personal profile, Kasdy's support Social, Eysenck Self-Esteem, Hudson's Marital Satisfaction, and Depression Anxiety and Stress (DASS 21) questionnaires.
Participants/Inclusion and exclusion criteria
En: written consent, Living in Mashhad,18 to 35 year old age range, Literacy reading and writing, gestational age 37 to 40 weeks. Ex: Having speech disorders or hearing problems, to have Medical diseasese, depression, severe anxiety and stress, using omega-3 supplementation or Aromatherapy, allergy to the flowers and the plants, Olfactory disorders, having marine foods more than two meals per week, abnormal fetus
Intervention groups
Aromatherapy group will receive routine postpartum care and inhale 3 droplets of orange essential oil for ten minutes, two times a day, from the second day after delivery for six weeks. The Omega-3 supplement group will receive routine postpartum care and one gr of omega 3 capsules immediately after lunch from the second day after delivery for six weeks. 3) Control group that receive only routine postpartum care.
Main outcome variables
the Incidence of postpartum depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170310032993N2
Registration date: 2018-06-22, 1397/04/01
Registration timing: retrospective

Last update: 2018-06-22, 1397/04/01
Update count: 0
Registration date
2018-06-22, 1397/04/01
Registrant information
Name
Afsaneh Mahdizadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 041 4362
Email address
mahdizadehaf941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2017-05-26, 1396/03/05
Expected recruitment end date
2017-08-27, 1396/06/05
Actual recruitment start date
2017-05-26, 1396/03/05
Actual recruitment end date
2017-09-16, 1396/06/25
Trial completion date
empty
Scientific title
Comparison of the effects of orange Essential oil and omega 3 in prevention of postpartum depression
Public title
Effect of orange Essential oil and omega 3 in prevention of post partum depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Written Consent Resident of Mashhad Literacy reading and writing Age 18-35 years old gestational age 37-41 weeks
Exclusion criteria:
Depression Severe anxiety and stress history of chronic medical illness history of postpartum depression history of psychiatric disorders sensory disorder flower and plant allergy Use of anticoagulant drugs BMI over 30 Having a speech and audio problem that prevents communication abnormal fetuses use of aroma or supplementation of omega-3 consumption of fish more than two times per week
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: 150
Actual sample size reached: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Based on randomized sequencing that determined by SPSS software, each of the research units will be placed in orange essential oil, omega-3 and control groups
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 Mashhad University of Medical Sciences
Street address
Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
---
Approval date
2017-05-20, 1396/02/30
Ethics committee reference number
ir.mums.rec.1396.50

Health conditions studied

1

Description of health condition studied
post partum 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
The incidence of postpartum depression
Timepoint
Before the intervention, the tenth day after delivery, 4 weeks after delivery, 6 weeks after delivery
Method of measurement
Edinburgh Depression Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Aromatherapy Group In addition to receiving usual post partum care, they inhale 3 drops of orange essential oil prepared by Gorgan Essential Oil Company for 10 minutes every 12 hours (morning and evening).
Category
Prevention

2

Description
Intervention group 2: Omega-3 supplementation group, in addition to receiving routine post-partum care, consumes a single gram of mercury free capsule omega-3.
Category
Prevention

3

Description
Control group: The control group receives routine postpartum care.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Dr Masoumeh Mirteimouri
Street address
Ommolbanin Hospital, Ayatolah Bahjat 16, Zarineh Crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
---
Phone
+98 51 3223 1065
Fax
Email
MirteimouriM@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
-
Email
tafaghodiM@MUMS.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Robab Latifnejad
Position
Vice President of Research and Faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
School of Nursing and Midwifery, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
-
Phone
+51 38591511
Fax
Email
latifnejadr@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Position
Faculty of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
-
Phone
+51 38591511
Fax
Email
tafazolim@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneh Mahdizadeh
Position
Midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
-
Phone
+51 38591511
Fax
Email
mahdizadehAF941@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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