]>
IRCT20220424054639N1 IRCT 2022-06-13 Mashhad University of Medical Sciences The Effect Of Oral Capsules Of Jujube Fruit Extract On The Prevention Of Postpartum Depression The Effect Of Oral Capsules Of Jujube Fruit Extract On The Prevention Of Postpartum Depression 2022-07-23 anticipated 128 Complete https://irct.ir/trial/63358 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: In This Study, Both Participants And Researchers Or Outcome Assessors Are Unaware Of The Allocation Of Study Groups. 3 Postpartum depression. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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 When: Access Period Starts From Six Months After The Results Are Published Until 1 Year Later To whom: The Data Will Be Available Only To Researchers Working In Academic And Scientific Institutions Conditions: In Order To Use The Data, Only The Responsible Researcher Should Be Contacted And It Will Be Possible To Publish Through Her Where to obtain: Applicants Should Contact The Research Officer Via Email JahaniSHN@mums.ac.ir How to obtain: A Data Request And Document Must Be Sent To The Responsible Author In The Form Of A Valid Academic Email Comments:
public Nahid Jahani Shoorab
Office of Midwifery, First Floor, Professors Building, School of Nursing and Midwifery, Daneshgah St.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 JAHANISHN@MUMS.AC.IR Mashhad University of Medical Sciences scientific Nahid Jahani Shoorab
Office of Midwifery, First Floor, Professors Building, School of Nursing and Midwifery, Ph.D.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 JAHANISHN@MUMS.AC.IR Mashhad University of Medical Sciences Iran (Islamic Republic of) 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) 18 years 40 years Female 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 F53 Puerperal psychosis Treatment - Drugs Placebo 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. 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. Depression Score Before And After The Intervention. Timepoint: 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. Method of measurement: Edinburgh Postpartum Depression Screening Questionnaire. Satisfaction With The Sex Of The Baby. Timepoint: At The Beginning Of The Study. Method of measurement: Demographic And Midwifery Profile Questionnaire. Mashhad University of Medical Sciences Approved 2022-05-10 Ethics Committee of Mashhad University of Medical Sciences No. 63, Motahhari St., Motahhari St., Islamic Republic Square Torbate Jam Razavi Khorasan Iran (Islamic Republic of)