Comparison of postpartum blues intensity in the study groups after intervention
Design
Clinical trial with sham control group, in parallel groups, triple blind, randomized, phase 3 on 74 patients. Randomization will be done using online random generator software.
Settings and conduct
This study is a randomized Sham controlled clinical trial, which will be performed on primiparous mothers at Kowsar Hospital in Qazvin. First external earlobes will be cleaned with 75% alcohol and then special non-latex adhesives with vaccaria seeds will be adhered with on 5 points of the left ear, including the endocrine master, my sand, Zero, Gonadotroin, Master cerbal and 2 points of right side includes the thalamic and antidepressant points. The number of interventions is 2 times with an interval of 5 days. Participants are taught to keep the seeds in their ears for five days, during this time, they must press each point three times a day for twenty seconds. In the control group, a similar visit is made and non-latex adhesives without vaccaria seeds will be placed on their ear. Therefore, the participant, clinical caregiver, and outcome assessor and data analyzer will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
In this study, primiparous women with term pregnancy and a singleton baby with a healthy earlobe will be invited to study.
Intervention groups
1- Intervention group of auriculotherapy
2- Sham control group
Main outcome variables
Intensity of postpartum blues
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038789N2
Registration date:2020-06-19, 1399/03/30
Registration timing:prospective
Last update:2020-06-19, 1399/03/30
Update count:0
Registration date
2020-06-19, 1399/03/30
Registrant information
Name
Zainab Alimoradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6003
Email address
z.alimoradi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of ear acupressure on postpartum blues: A randomized sham controlled trial
Public title
Investigating the effect of ear acupressure on postpartum blues
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Being primiparous
Born a full term, singleton baby
Having a healthy earlobe with no lesions, sores and pain in the earlobe
Being Iranian
Being literate at least with ability in reading and writing
Availability during the study period (residence in Qazvin city)
Exclusion criteria:
Complications in pregnancy and postpartum (e.g. preterm delivery, preeclampsia, gestational diabetes, infant in need of special care, etc.)
History of chronic mental and physical illness (self-report and review of the individual's file)
Drug abuse in the individual or his spouse
History of acupressure in the last three months
History of stressful events in the last three months (such as the loss of loved ones)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done using balanced block randomization methods with each block size of 4. The allocation sequence will be generated using online software. After preparing the allocation sequence, the sequence will be written down on paper in order and placed inside the closed sealed envelopes. Envelopes are numbered sequentially. Questionnaires are coded in the same way. Accordingly, each person will be assigned to one of the intervention or control groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the control group will receive the same intervention as the main group ( sham control). Therefore, participants will not know what group they are in. Since the clinical caregiver and the outcome assessor and data analyst are not aware of this, blindness of the second and third levels will also be implemented.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Approval date
2020-05-20, 1399/02/31
Ethics committee reference number
IR.QUMS.REC.1399.050
Health conditions studied
1
Description of health condition studied
Postpartum blues
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of postpartum blues
Timepoint
pre-intervention, 5 , 10 , 15 days after intervention
Method of measurement
Maternity Blues Questionnaire
Secondary outcomes
1
Description
Intensity of postpartum tiredness
Timepoint
pre- intervention, 5, 10, 15 , 21 days after intervention
Method of measurement
Iowa tiredness scale
2
Description
Maternal attachment
Timepoint
pre- intervention, 5, 10, 15 , 21 days after intervention
Method of measurement
Muller Maternal Attachment Index
3
Description
Intensity of postpartum depression
Timepoint
21 days after intervention
Method of measurement
Edinburgh Postnatal Depression scale
Intervention groups
1
Description
Intervention group: Auriculotherapy
Category
Prevention
2
Description
Control group: Sham control
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital, Qazvin
Full name of responsible person
Zainab Alimoradi
Street address
Vali-Asar Avenue
City
Qazvin
Province
Qazvin
Postal code
34156-13176
Phone
+98 28 3323 6374
Email
zainabalimoradi.sbmu.ac.ir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr EmamJomeh
Street address
Shahid Bahonar Boulevard- Qazvin University of Medical Sciences- School of Nursing & Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 8034
Email
zainabalimoradi.sbmu.ac.ir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bahonar Blouvard, Qazvin University of Medical Sciences, School of Nursing and Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 8034
Email
zainabalimoradi.sbmu.ac.ir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bahonar Blouvard, Qazvin University of Medical Sciences, School of Nursing & Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 8034
Email
zainabalimoradi.sbmu.ac.ir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bahonar Bouleavrd. qazvin University of Medical Sciences- School of Nursing and Midwifery
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
0982833338034
Email
zainabalimoradi.sbmu.ac.ir@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data related to the study will be published as an anonymous and unrecognizable file at the same time as the publication of the results as an appendix.
When the data will become available and for how long
After the publication of the article, the results of the data design will be available
To whom data/document is available
All people can access the data by referring to the appendix of published article
Under which criteria data/document could be used
All people with no limitation can access data
From where data/document is obtainable
Appendix of published article
What processes are involved for a request to access data/document