Protocol summary
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Study aim
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Determining The Effect Of Jujube Fruit Capsule On The Prevention Of Postpartum Depression
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Design
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Clinical Trial With Control Group, With Parallel Groups, Double-Blind, On 128 Samples. Stratified Face Sampling And Then Accident Allocation
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Settings and conduct
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Research environment of Torbat-e-Jam health center, all comprehensive urban health service centers under the auspices of this center. The research and sampling community is done in a class of 4 comprehensive urban health service centers and then random allocation is done by block method. , The evaluator and the statistical analyst are not aware of the intervention and control group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Informed consent, 18-40 year old women, wanted pregnancy, no history of recurrent miscarriage or infertility, being on the 10th day after normal delivery, low-risk pregnancy, no stress, depression and severe anxiety, score less than 12 of the Edinburgh Depression Test, no jujube hypersensitivity, no treatment for depression, no history of medical or mental illness.
Conditions of non-entry: unwillingness to continue research, not taking medication for two consecutive days, major stress during the study, depression during the study diagnosed by a psychiatrist, the baby has an abnormality or death of the baby, smoking, drinking alcohol or Consumption of any drug
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Intervention groups
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Intervention group: They will receive 1200 mg of jujube fruit extract daily in the form of two 750 mg capsules after breakfast and dinner and will complete the Edinburgh Depression Inventory two weeks, four weeks and six weeks after the start of the intervention.
Control group: It is quite similar to the control group, but instead of the jujube fruit extract capsule, it receives a capsule containing a placebo.
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Main outcome variables
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Depression Score Before And After The Intervention
General information
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Reason for update
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Change The Name Of The Scientific Supervisor Of The Project From The Name Of The Student To The Name Of The Project Supervisor
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220424054639N1
Registration date:
2022-06-13, 1401/03/23
Registration timing:
prospective
Last update:
2022-06-19, 1401/03/29
Update count:
1
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Registration date
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2022-06-13, 1401/03/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-07-23, 1401/05/01
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Expected recruitment end date
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2023-07-23, 1402/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect Of Oral Capsules Of Jujube Fruit Extract On The Prevention Of Postpartum Depression
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Public title
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The Effect Of Oral Capsules Of Jujube Fruit Extract On The Prevention Of Postpartum Depression
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Conscious Consent Of The Mother
Women 18-40 Years Old
Recent Pregnancy Asked
No History Of Recurrent Miscarriage Or Infertility
Resident Of Torbate Jam
Live With His Wife
On The 10th Day After Normal Delivery Without Complications (Complication: Any Obstetric Complications Such As High Blood Pressure, Diabetes Or Hospitalization Of The Mother Due To Postpartum Complications)
Having A Low-Risk Pregnancy (Low-Risk Pregnancy: A Pregnancy That Has No Potential Side Effects That Threaten The Health Of The Mother And Fetus)
Having A Mobile Phone Number
No Stress, Depression And Severe Anxiety (Depression And Severe Anxiety: Scores Of 24 And Above On The Stress Subscale And 15 And More On The Anxiety Subscale And 21 And More On The DASS-21 Questionnaire)
Score Less Than 12 On The Edinburgh Depression Test
Do Not Be Allergic To Jujube
No Accidents (Accidents Such As The Death Or Hospitalization Of A Family Member During The Last Three Months)
Do Not Currently Be Treated For Depression
Have No Medical History (Medical Conditions: Hypertension, Hypothyroidism And Parathyroidism, Heart Disease, Kidney Disease, Hypertension Under Treatment, Migraine, Epilepsy, Respiratory Disease, Hyperlipidemia, Diabetes)
Do Not Have Any Mental Illness (Mental Illness: A History Of Depression Or Neurological Disease Or Any Other Mental Disorder According To The Patient)
Exclusion criteria:
Reluctance To Continue Research
Do Not Take The Drug For Two Consecutive Days
Incidence Of Jujube Allergy
Major Stress During Study(Major Stress: Serious Illness Of Yourself Or A Spouse, Death Of A Loved One, Unemployment, Accidents And Severe Family Disputes)
Depression While Studying With A Psychiatrist Diagnosis
The Baby Has An Abnormality Or The Baby Dies
Change Of Residence During The Study
Smoking, Drinking Alcohol Or Taking Any Drugs
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
128
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This Study Will Be Performed As A Three-Blind Randomized Controlled Clinical Trial. The Research Environment Is Torbate Jam Health Center And All Comprehensive Urban Health Service Centers (All Four Urban Service Centers) Under The Auspices Of This Center Will Be Selected As The Research Community. Sampling Is Done In A Class Of 4 Comprehensive Urban Health Service Centers And Then Random Allocation (The Method Of Allocating People To Two Groups Will Be Random And Using The Method Of 4 Blocks). The Randomization Tool Will Be A Table Of Random Numbers.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In This Study, Both Participants And Researchers Or Outcome Assessors Are Unaware Of The Allocation Of Study Groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-05-10, 1401/02/20
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Ethics committee reference number
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IR.MUMS.NURSE.REC.1401.016
Health conditions studied
1
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Description of health condition studied
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Postpartum depression
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ICD-10 code
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F53
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ICD-10 code description
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Puerperal psychosis
Primary outcomes
1
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Description
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Depression Score Before And After The Intervention
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Timepoint
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At The Beginning Of The Study And At The End Of The Second, Fourth And Sixth Weeks After Entering The Study, The Depression Score Will Be Measured.
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Method of measurement
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Edinburgh Postpartum Depression Screening Questionnaire
Secondary outcomes
1
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Description
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Satisfaction With The Sex Of The Baby
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Timepoint
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At The Beginning Of The Study
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Method of measurement
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Demographic And Midwifery Profile Questionnaire
Intervention groups
1
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Description
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Intervention group: Includes An Intervention Group That In Addition To Receiving Routine Care Performed By Midwives Working In Comprehensive Health Service Centers On Days 1-3, 10-15, 30-42 After Delivery, Recipient Of Oral Capsules Of Jujube Fruit Extract From The Tenth Day Are After Childbirth. Mothers In This Group Will Receive 1200 Mg Of Jujube Fruit Capsules Daily Along With 300 Mg Of Excipients Including Avisel In The Form Of Two 750 Capsules Twice A Day For Half An Hour After Breakfast And Dinner For Six Weeks And A Depression Questionnaire. After Giving Birth To Edinburgh, This Group Will Be Completed At The End Of The Second, Fourth And Sixth Weeks After Entering The Study. Inform The Researcher Of Any Allergies, Problems Or Any Side Effects Through The Contact Number Provided To Them.
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Category
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Treatment - Drugs
2
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Description
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Control group: Includes A Control Group (Receiving Placebo Capsules): In Addition To Receiving Routine Postpartum Care, The Control Group Will Receive A Placebo Capsule Containing 750 Mg Of Oisel Powder Twice Daily After Breakfast And Dinner For 6 Weeks. Routine Postpartum Care Includes Routine Midwifery Care On Days 1-3, 10-15, 30-42 After Delivery By The Midwife. Mental Health Screening In The First, Second And Third Postpartum Care Is Based On The Edinburgh Questionnaire, And If The Evaluation Results Are Positive Based On The Cut-Off Point Of The Questionnaire (Score 12 And Above), The Mother Suffers From Postpartum Depression And Should Be Additional Evaluation Should Be Referred To A Doctor Immediately (At The Earliest Opportunity).Mothers Whose Test Scores Are 12 And Older Suffer From Postpartum Depression. Scores 14 And 15 Are Severe Depression. Women With Some Symptoms Of Depression (No Suicidal Ideation) Or A Score Between 5 And 9 Should Be Re-Evaluated A Month Later. The Edinburgh Postpartum Depression Inventory For This Group Is Completed At The End Of The Second, Fourth And Sixth Weeks After Entering The Study.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Statistical Data And Results Of Statistical Analysis Will Be Shared In The Form Of Tables And Graphs. Some Of The Forms And Questionnaires Used Will Be Shared
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When the data will become available and for how long
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Access Period Starts From Six Months After The Results Are Published Until 1 Year Later
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To whom data/document is available
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The Data Will Be Available Only To Researchers Working In Academic And Scientific Institutions
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Under which criteria data/document could be used
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In Order To Use The Data, Only The Responsible Researcher Should Be Contacted And It Will Be Possible To Publish Through Her
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From where data/document is obtainable
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Applicants Should Contact The Research Officer Via Email
JahaniSHN@mums.ac.ir
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What processes are involved for a request to access data/document
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A Data Request And Document Must Be Sent To The Responsible Author In The Form Of A Valid Academic Email
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Comments
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