Determining the effect of Auriculotherapy on postpartum depression
Design
A randomized clinical trial, a blind side
Settings and conduct
This study is a single-blind clinical trial that is performed in health centers in Behbahan. The samples include women with postpartum depression, the sample size is 134 people and the duration of the intervention is 10 days. The Edinburgh Maternity and Postpartum Depression Inventory is completed by individuals. Eligible samples are randomly divided into intervention and control groups. In the intervention group, granular labels are placed on the relevant points, it is recommended to apply pressure on the labels for 4 minutes every 4 hours. In the control group, the seedless labels, which appear to be similar to the intervention group in shape and color, are affixed by the researcher in non-depressive areas without any pressure, and they are asked to apply these labels to the ears of people without No compressive actions remain.
Participants/Inclusion and exclusion criteria
Admission requirements: Iranian and resident of Behbahan city, at least 6 weeks of childbirth, no physical illness, no acute mental illness and literacy in the level of reading and writing and in the post-delivery depression questionnaire Edinburgh 13 and Earned higher (EPDS≥13).
Conditions for not entering: Criteria for leaving the study include: severe depression, manic episodes with irritable bowel syndrome, adjustment disorder with depressed mood, sadness, ADHD; Mothers who have the potential to commit suicide in the current period and need immediate treatment. Mothers who, for whatever reason, are reluctant to continue their treatment.
Intervention groups
Intervention group: Auriculotherapy
Control group: Seedless and unrelated labels
Main outcome variables
Postpartum Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047466N1
Registration date:2021-08-23, 1400/06/01
Registration timing:prospective
Last update:2021-08-23, 1400/06/01
Update count:0
Registration date
2021-08-23, 1400/06/01
Registrant information
Name
Mahbubeh Jamei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5283 0225
Email address
mahbubeh.jamei6244@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-02, 1400/06/11
Expected recruitment end date
2021-10-03, 1400/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of auriculotherapy on postpartum depression
Public title
The effect of Auriculotherapy on Postpartum depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian
resident of Behbahan city
at least 6 weeks of childbirth
lack of physical illness
acute mental illness and illiteracy
in reading and writing
Score 10 or higher on the Edinburgh Questionnaire
Exclusion criteria:
Severe depression
manic episodes with irritable bowel syndrome
compatibility disorder with depressed mood, sadness
Mothers who have the potential to commit suicide in the current period and need immediate treatment
Mothers who, for whatever reason, are reluctant to continue their treatment
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals will be randomly assigned to one of the intervention or control groups. Each person is assigned a code and then randomly assigned by pairing and individualizing the codes.
Blinding (investigator's opinion)
Single blinded
Blinding description
To perform the intervention in the auriculotherapy group, the researcher pasted the Vaccaria granular labels on the 6 points related to depression after applying the ear massage and applied them on the pressure points for 2 minutes and taught them to label them every 2 hours for 2 minutes. Press the granules on each point with your finger, and they are also asked to repeat the procedure for 10 days. The shape and color are pasted by the researcher in areas not related to depression without any pressure and they are asked to keep the labels on the ear without any pressure until the end of the study. A description of the treatment will be given.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Golestan St., Ahvaz University of Medical Sciences
City
ahwaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2020-04-03, 1399/01/15
Ethics committee reference number
IR.AJUMS.REC.1399.058
Health conditions studied
1
Description of health condition studied
Postpartum Depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postpartum Depression
Timepoint
Before the intervention, after the intervention
Method of measurement
Postpartum depression questionnaire Edinburgh
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Auriculotherapy / every 4 hours 2 minutes / 10 days
Category
Treatment - Other
2
Description
Control group: Seedless labels that appear to be similar in shape and color to the intervention group and are affixed to non-depressive areas without any pressure and are asked to apply these labels to the ears of people without No compressive actions remain.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Behbahan health centers
Full name of responsible person
Mahbubeh Jamei
Street address
Behbahan School of Medical Sciences
City
Behbahan
Province
Khouzestan
Postal code
6361913719
Phone
+98 61 3733 8358
Email
mahbubeh.jamei6244@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badvi
Street address
Golestan Boulevard،Ahwaz University of Medical Sciences
City
ahwaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 3733 3838
Fax
Email
badvi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
mahbubeh jamei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan, Ahwaz University of Medical Sciences, School of Midwifery Nursing
City
ahwaz
Province
Khouzestan
Postal code
6195893774
Phone
+98 61 3373 8331
Email
mahbubeh.jamei6244@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnori
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahwaz University of Medical Sciences, School of Nursing and Midwifery
City
ahwaz
Province
Khouzestan
Postal code
6195893774
Phone
0098 61 3738331
Email
javadnoori-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahboubeh Jamei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahwaz University of Medical Sciences, School of Nursing and Midwifery
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3733 1338
Email
mahbubeh.jamei6244@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
The data will be sent to the responsible author upon publication upon request.
When the data will become available and for how long
Information after the publication of the article will be available upon request from the responsible author.
To whom data/document is available
The data will be available to researchers after obtaining permission.
Under which criteria data/document could be used
Researchers can send an e-mail to the author requesting information.
From where data/document is obtainable
Ahwaz, Golestan St., Ahwaz University of Medical Sciences, Faculty of Nursing and Midwifery, Mojgan Javad Nouri
What processes are involved for a request to access data/document
The requested information will be sent after receiving the email.