UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053050 |
|---|---|
| Receipt number | R000060527 |
| Scientific Title | Investigate the effect of transcranial Direct Current Stimulation of the brain on emotion regulation in Women had postpartum depression |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2023/12/10 15:31:57 |
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Basic information
Public title
transcranial Direct Current Stimulation of the brain on emotion regulation in Women had postpartum depression
Acronym
tDCS on emotion regulation in woman had ppd
Scientific Title
Investigate the effect of transcranial Direct Current Stimulation of the brain on emotion regulation in Women had postpartum depression
Scientific Title:Acronym
Investigate the effect of tDCS on emotion regulation in Women had ppd
Region
| Asia(except Japan) |
Condition
Condition
Semi-experimental research
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postpartum depression is a type of depression that many mothers experience after the birth of their child. Affects more than 1 in 10 women during the postpartum year. The aim of this study was to investigate the effect of transcranial Direct Current Stimulation on emotion regulation in Women had postpartum depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Data analysis showed that the score of emotion regulation test in women with postpartum depression after active treatment was significantly reduced compared to the control group with dummy electrical stimulation (P <0.05).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
each patient received 10 sessions of dummy electrical stimulation (20 minutes) and in the experimental group received 10 sessions of simultaneous anodic and cathodic stimulation (2 mA - 20 minutes) in the left and right dorsal peripheral cortex, respectively
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
The inclusion criteria were having postpartum depression according to clinical tests and psychiatrist confirmation, age range of 30 to 40 years, not using other treatment methods such as psychotherapy and psychiatric drugs.
Key exclusion criteria
The exclusion criteria were the presence of a disorder other than postpartum depression, the use of psychiatric drugs, and lack of motivation to participate in the research.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mohsen |
| Middle name | |
| Last name | Saeidmanesh |
Organization
Science and Arts University
Division name
Yazd
Zip code
8915813130
Address
shohadayegomnam Blvd
TEL
989133595219
m.saeidmanesh@yahoo.com
Public contact
Name of contact person
| 1st name | Fatemeh |
| Middle name | |
| Last name | Hajikhalili |
Organization
Science and Arts University
Division name
Yazd
Zip code
8915813130
Address
shohadayegomnam Blvd
TEL
989135369841
Homepage URL
fatimahajikhalili@gmail.com
Sponsor or person
Institute
Science and Arts University
Institute
Department
Personal name
Funding Source
Organization
This research did not receive any grant from funding
agencies in the public, commercial, or non-profit sectors
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Academic Center for Education
Address
Mashhad
Tel
985131997000
Ethics@acecr.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 10 | Day |
Last modified on
| 2023 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060527
