Investigating the effectiveness of mindfulness counseling on mother - newborn attachment and The stress of at risk newborn parent under the care ACORN program
Evaluation of the effectiveness of mindfulness counseling on maternal and infant attachment and High-risk infants parental stress in care under the ACORN program
Design
The clinical trial has a control group, with parallel groups, randomized with online software by a statistical consultant, the sample size is 50 parents (100 people).
Settings and conduct
A parallel randomized controlled trial study was performed in 2021 on 50 parents (both parents) with infants admitted to the neonatal intensive care unit of Mobini Hospital in Sabzevar. . Due to the nature of the interventions, it is not possible to blind parents.
Participants/Inclusion and exclusion criteria
Admission requirements:
1.Having an unhealthy or at-risk baby under ACORN care.
2.Be literate.
3.No history of illness or mental disorders or taking psychiatric medication.
4.Predicting more than 2 weeks of hospitalization in the neonatal intensive care unit.
5.Meet the baby at least once a day.
6.Getting a score higher than 34 from the Parent Stress Scale Questionnaire in the Neonatal Intensive Care Unit.
7.Possibility and ability of the participants to use the Online meetings(if the corona conditions are continuous and it is not possible to hold the meetings in person).
Conditions for not entering the study:
1.Parents who have experienced stressful life events over the past year.
2.Parents who received out-of-study counseling services.
3.It is not possible for the parents to see the baby
Intervention groups
The intervention group receives mindfulness-based counseling in 3 sessions of 60 minutes a week every other day, and the control group receives only one session of infant massage training.
Main outcome variables
Maternal and infant attachment, parental stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201208049647N1
Registration date:2020-12-14, 1399/09/24
Registration timing:prospective
Last update:2020-12-14, 1399/09/24
Update count:0
Registration date
2020-12-14, 1399/09/24
Registrant information
Name
Masomeh Nodeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4537 5025
Email address
nodeh@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of mindfulness counseling on mother - newborn attachment and The stress of at risk newborn parent under the care ACORN program
Public title
Investigating the effectiveness of mindfulness counseling on mother - newborn attachment and The Parental stress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having an unhealthy or at-risk baby under ACORN care
Be literate
No history of illness or mental disorders or taking psychiatric medication
Predicting more than 2 weeks of hospitalization in the neonatal intensive care unit
Meet the baby at least once a day
Getting a score higher than 34 from the Parent Stress Assessment Questionnaire in the Neonatal Intensive Care Unit
Possibility and ability of the participants to use the Online meetings(if the corona conditions are continuous and it is not possible to hold the meetings in person)
Exclusion criteria:
Parents who have experienced stressful life events over the past year
Parents who received out-of-study counseling services
It is not possible for the parents to see the baby
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Creating a random sequence is done by online software using 4 blocks and according to the number of samples 50 and the number of blocks (13) by the esteemed consultant of statistics. A table of 52 of sequences A and B is prepared and the closed envelope method is used to hide the allocation. In this method, based on the specified sequence, 13 blocks (each block contains 4 envelopes containing the letter (A (case) or B (control)) are prepared according to the random sequence table and in the order that the researcher is not aware of, Will be provided to the researcher. After selecting the eligible individuals and obtaining informed consent, the researcher will open the door of the envelope corresponding to the participating parents and assign the parents to the intervention or control group based on the type of group registered in it.
Therefore, researchers do not know the order of random allocation.
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
Ethics committee of Shahrood University of Medical Sciences
Street address
Corner of Shahid Bahonar Street, No. 738
City
Neghab
Province
Razavi Khorasan
Postal code
9647135448
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.SHMU.REC.1399.124
Health conditions studied
1
Description of health condition studied
Mother and baby attachment
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Parental stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mother and baby attachment
Timepoint
Measuring the average score of mother and infant attachment in 3 times: Before the intervention, in the last session (7 days after the intervention) and 14 days after the intervention
Method of measurement
Checklist of Avant attachment behaviors
2
Description
Parental stress
Timepoint
Measuring the average score of Parental stress in 3 times: before the intervention, in the last session (7 days after the intervention) and 14 days after the intervention
Method of measurement
Parental stress scale In the neonatal intensive care unit questionnaire
Secondary outcomes
1
Description
Duration of the baby's hospitalization
Timepoint
One month after the start of the intervention
Method of measurement
Number of days of hospitalization of the infant recorded in the hospital file
Intervention groups
1
Description
Intervention group: The intervention group receives mindfulness-based counseling in 3 sessions of 60 minutes a week every other day. These sessions include: Session 1: Familiarity with the basics and foundations of mindfulness, Session 2: Attitudes that nurture mindfulness, Session 3: Mindfulness versus lack of mindfulness and conscious listening.
Category
Other
2
Description
Control group: The control group receives only one session of infant massage training on the first day of the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Mobini Hospital
Full name of responsible person
Masomeh Nodeh
Street address
No.12, North Kashfi Street, Mobini Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9648177444
Phone
+98 51 4401 1000
Email
info@medsab.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Masomeh Nodeh
Street address
Shahroud, 7th of Tir Square, Shahroud University of Medical Sciences and Health Services
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Masomeh Nodeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Corner of Shahid Bahonar St., No. 738
City
Neghab
Province
Razavi Khorasan
Postal code
9647135448
Phone
+98 51 4522 0939
Email
nodes1368@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Masomeh Nodeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Corner of Shahid Bahonar St., No. 549
City
Neghab
Province
Razavi Khorasan
Postal code
9647135448
Phone
+98 51 4522 0939
Email
nodes1368@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Masomeh Nodeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 738, Corner of Shahid Bahonar Street
City
Neghab
Province
Razavi Khorasan
Postal code
9647135448
Phone
+98 51 4522 0939
Email
nodes1368@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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