Evaluating the Effect of Tele continuous care on Postpartum Adaptation and Neonate Perception among Primiparous women.
Design
Randomized controlled field trial on 48 samples.The block sampling was used for random allocation using Excel software to form the groups. Samples were divided into intervention and control groups by quadruple random blocks.
Settings and conduct
The research population are among primiparous women hospitalized in the postpartum department of the selected Maternity and Gynecology center of east of Tehran.The intervention group will recieve tele-continuous care during six weeks after delivery while the control group only benefits from the routine three separated postpartum care given in Health centers.
Participants/Inclusion and exclusion criteria
Eligible participants include Iranian primiparous women aged 18 years old or older who are able to communicate with mobile phones and messaging apps and only the singleton mothers whose gestational age is over 37 weeks with their baby's weight > 2500 gr and the APGAR score > 7 immidiately after birth, will be enrolled. Getting a score of 15 or more from the Edinburgh Postpartum Depression Scale or occurring any serious health problem in mothers or their babies, are the exclusions criteria.
Intervention groups
The continuous postpartum care involved postnatal support by a midwife at first visit in the hospital and a six week follow-up after delivery providing health education and midwifery counseling based on the individual needs and conditions of each client via phone calls and messaging apps to send videos and educational content during the postpartum period. The control group will only benefits from routine postpartum care provided in comprehensive health centers after discharge from hospital.
Main outcome variables
Postpartum adaptation and neonatal perception in primiparous women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160424027557N9
Registration date:2022-12-20, 1401/09/29
Registration timing:prospective
Last update:2022-12-20, 1401/09/29
Update count:0
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Mahnaz Akbari Kamrani
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
dr.akbarikamrani@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-04-09, 1402/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tele continuous Care on Postpartum Adaptation and Neonate Perception among Primiparous women
Public title
Effect of Tele continuous Care on Postpartum Adaptation and Neonate Perception
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women
Iranian nationality and proficiency in Persian language
Ability to use cell phones and messaging apps
Being married
Age over 18 years old
Delivering single birth
Birth of a healthy and full term baby
Absence of known medical or mental disease according to self statement
Not being addicted and not having the history of opioids, amphetamines and alcohol use
Signing the informed voluntary consent form
Exclusion criteria:
Occurring any serious medical complications in mother or neonate during the study
Obtaining a 15 or higher depression score from the Edinburgh Postpartum Depression Questionnaire
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The block sampling was used for random allocation using Excel software to form the groups. Samples are divided into intervention and control groups by quadruple random blocks. There are six possibilities for blocking (BAAB, ABAB, AABB, ABBA, BBAA, BABA). First, one of the blocks is selected and four of the participants in that block will be selected. As a result, the number A belongs to the intervention group and the number B belongs to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Reaearch Ethics comittees of Alborz University of Medical Science
Street address
Research Ethics Committees of Alborz University of Medical SiencesTaleghani square, north Taleghani boulvard, Karaj, Alborz Medical University
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.ABZUMS.REC.1401.246
Health conditions studied
1
Description of health condition studied
Continuous postpartum follow up
ICD-10 code
Z39.2
ICD-10 code description
Encounter for routine postpartum follow-up
Primary outcomes
1
Description
Postpartum adaptation score
Timepoint
Assessment the postpartum adaptation score within the second and sixth weeks after delivery
Method of measurement
Barkin Index of Maternal Functioning
2
Description
Neonate perception score
Timepoint
Assessment the neonate perception score within the second and sixth weeks postpartum
Method of measurement
The Newborn Perception Scale Broussard and Hanter 1971
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Primiparous Iranian women aged >18 giving birth to a single healthy full-term newborn. After the first visit at the postpartum department of the chosen hospital and providing the health tips and breastfeeding consultation to the new mothers and obtaining the consent form and completing the demographic questionnaire, the intervention group will undergo a six week follow up via phone calls and messaging apps in order to provide the relevant health educations such as Neonatal Screening programs, postnatal examinations in health centers, diagnosing the warning signs in mother or baby and providing the individual consultations involving lactating and feeding problems, baby care, complement use, taking care of the stump, baby sleep tips, safely bathing and massaging the baby, telling helpful tips to relieve colic pains, emphasizing on husband support, sexual health and family planning consultations, scoring the postpartum depression scale and responding to the questions and health concerns of the mother and so on. In the second and sixth weeks post delivery, the postpartum adaptation and neonatal perception questionnaires will be asked from participants.
Category
Lifestyle
2
Description
Control group: Primiparous Iranian women aged >18 giving birth to a single healthy full-term newborn. After the first visit at the postpartum department of the chosen hospital and providing the health tips and breastfeeding consultation to the new mothers and obtaining the consent form and completing the demographic questionnaire, the control group will only benefits from the routine separate postnatal visits in health centers. In the second and sixth weeks post delivery, the postpartum adaptation and neonatal perception questionnaires will be asked from participants.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Fateme Arank
Street address
No.162 Ave, Baghdarnia St, Tehranpars
City
Tehran
Province
Tehran
Postal code
165315981
Phone
+98 21 7788 3283
Fax
Email
hosp_arash@tums.ac.ir
Web page address
https://arash.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr Razieh Lotfi
Street address
Vice-Chancellor for Reaserch and Technology,Alborz University of Medical Sciences,North Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3256 3324
Fax
+98 26 3256 3325
Email
Research@abzums.ac.ir
Web page address
https://abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Fateme Arank
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No7, Shirood Alley, Shahed Blvd, Tehranpars, Tehran
City
Tehran
Province
Tehran
Postal code
1654815371
Phone
+98 21 7670 4709
Email
arangfateme@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Akbari Kamrani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medicine Faculty, Nabovat Square, Booali Blvd
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7339
Email
Dr.akbarikamrani@abzums.ac.ir
Web page address
https://medicine.abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Akbari Kamrani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medicine Faculty, Nabovat Square, Booali Blvd
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7339
Email
Dr.akbarikamrani@abzum.ac.ir
Web page address
https://medicine.abzums.ac.ir
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
Yes - There is a plan to make this available
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
All collected variables
When the data will become available and for how long
From 2023
To whom data/document is available
It will be available only for people working in academic institutions
Under which criteria data/document could be used
No criterion
From where data/document is obtainable
By Email: Dr.akbarikamrani@abzums.ac.ir and Dr. Mahnaz Akbari Kamrani would be responsive
What processes are involved for a request to access data/document