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The effect of developmental supportive Intervention by mothers on the mother's - infant attachment and growth of premature infants

Protocol summary

Study aim
The effect of developmental supportive Intervention by mothers on the mother's - infant attachment and growth of premature infants.
Design
A Randomized Clinical Trial with a parallel groups, single-blind, randomized, 60 premature infants (30 in the control group and 30 in the intervention group) were included in the study, Random Allocation Software was used for randomization.
Settings and conduct
This study will be conducted on premature infants hospitalized in the Neonatal Intensive Care Unit of Rouhani Hospital. Developmental support intervention with emphasis on two educational modules (minimizing stress & pain, safeguarding sleep, positioning & handling & protecting skin, optimizing nutrition with breast milk) starts seven days before the possible date of the infant's discharge and it will continue for five consecutive days. Blinding will be done only for the evaluator and data analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age less than or equal to 34 weeks for infants and for mothers, having a smart cell phone with at least one messenger. Exclusion criteria: infants who are hospitalized in the ward for less than five days and more than 30 days, and mothers who were doctors or nurses, and mothers who will be absent for more than two consecutive days during the study process.
Intervention groups
attachment will be recorded using the mother-infant attachment questionnaire and the growth indices of all infants based on the Fenton curve at the beginning of the study (birth, hospitalization, discharge) and one and two months after discharge. Two educational modules (Developmental Supportive Care) will be taught to mothers in the intervention group in five sessions.
Main outcome variables
The primary outcome is premature infant growth and mother-infant attachment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240327061370N1
Registration date: 2024-04-29, 1403/02/10
Registration timing: prospective

Last update: 2024-04-29, 1403/02/10
Update count: 0
Registration date
2024-04-29, 1403/02/10
Registrant information
Name
Afsaneh Arzani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0557
Email address
a.arzani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of developmental supportive Intervention by mothers on the mother's - infant attachment and growth of premature infants
Public title
The effect of developmental supportive Intervention by mothers on the mother's - infant attachment and growth of premature infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age less than or equal to 34 weeks Infants who do not have life-threatening abnormalities Mothers who are the main caregiver of the infants after discharge are included in the study Iranian mothers Mothers who can read and write Mothers who do not suffer from physical and mental diseases based on self-report Mothers who have a smartphone with at least one messenger Mothers who consent to participate in the study
Exclusion criteria:
Infants who are hospitalized in the ward for less than five days and more than 30 days Mothers who are doctors or nurses Mothers who are absent for more than two consecutive days during the study process
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that the research samples are not included in the study at the same time and the researcher does not know which group each person who enters the study will belong to, in order to assign the target group to one of the intervention and control study groups (two groups A and B), the block randomization method with six blocks will be used. Then, the participants will be assigned to one of the two control and intervention groups according to the block random allocation protocol (produced by Random Allocation Software) with a ratio of 1:1, so that the researcher cannot predict which group the next person will be in. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that it is not known which group the next person belongs to. Allocation concealment refers to the method used to perform a random sequence on study participants, so that the assigned group is not kno wn before the individual is assigned. Without hiding the random sequence, it is possible to reveal the random sequence, which ultimately weakens the randomization process. Therefore, it is necessary to make a decision to accept or reject participation in the study first and complete the informed consent form, and then the participants are assigned to each of the groups. Different methods can be used to hide the random allocation. In this study, the method of sealed opaque envelopes with random sequence will be used. Based on the sample size of this research, a number of opaque letter envelopes (in order to make the contents of the envelopes unknown) are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the letter envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box respectively. At the time of registration, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, considering that after randomization, mothers and the researcher cannot be blinded (because the type of intervention is known), so blinding cannot be done in the first stage. On the other hand, the measurement of most of the results in this study is objective (measurement of weight, height and head circumference of premature babies hospitalized in the neonatal intensive care unit). Therefore, blinding will be done only for the evaluator and data analyzer.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committee of health research institute - Babol University of Medical Sciences
Street address
Ganj Afrouz Avn., Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.208

Health conditions studied

1

Description of health condition studied
Developmental Supportive Care
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Growth of premature infants
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Mother - infant attachment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
1.infant growth
Timepoint
At birth, hospitalization, discharge, one and two months after discharge
Method of measurement
Soft plastic meter and Seka digital scale (made in Germany, the accuracy of which is five grams) and Fenton growth curve of premature infant

2

Description
2. mother-infant attachment
Timepoint
At birth, hospitalization, discharge, one and two months after discharge
Method of measurement
Maternal Attachment Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Two educational modules (developmental supportive care) will be taught to mothers in five sessions. Before starting the sessions, informed consent will be obtained from the mother, and if she wants to participate in the study, the researcher will introduce herself to the mother and explain the method of conducting the research to the mother in general, without the mother knowing about the existence of two groups and Accordingly, she will be informed whether she will be in the intervention or control group, and then the time of the first appointment will be determined and the meeting place will be introduced to her. In the first session, explanations are given about the developmental support program for infants and the timing of the program. Then, a educational pamphlet about developmental supportive intervention with educational content is distributed to the participants of the intervention group. The second session includes the first training module that includes the pain and stress reduction subsystem. The mother will be taught about reducing sources of stress such as bright lights and loud noises and infant stress symptoms and stress reduction strategies, pain assessment and management, behavioral and physiological signs of pain, and non-pharmacological methods of pain control. they will also be taught about comfortable positions, skin-to-skin contact, and kangaroo care. The third session is the second sub-system of the first training module, which will be about safeguarding sleep. In this session, the infant's sleeping and waking patterns, circadian rhythms, strategies to improve a comfortable sleep, clustering care, for example, changing diapers and clothes at the same time to reduce manipulation of the infant and disturbing his rest, are explained to the mother in simple language. The fourth session of the second educational module includes: how to position the infant and protect the infant's skin. In this session, the principles of positioning the infant and placing the infant in the midline of the body, placing the infant in a fetal position and using positioning aids such as a cradle will be taught. Also, the assessment of the infant's body moisture, the assessment of the infant's skin according to the skin assessment tool of the World Health Organization, bathing with sponges and swaddling clothes are explained to mothers in simple language. The fifth session is the continuation of the second educational module, which is about breastfeeding. In this session, we will teach about breast milk and its benefits, breast pumping, correct breastfeeding, non-nutritive sucking, symptom-based feeding, early and frequent care, the effect of skin-to-skin contact and kangaroo care in optimal breastfeeding. Each training session will last between 30 and 45 minutes, and the training will be done using the face-to-face method, pamphlets and educational videos, and the content of each session for more emphasize after face to face education, will be placed in the developmental support care channel of one of the . Smart phone virtual messenger - (ITA)- so that the mother has constant access to educational content and can benefit from education in case of absence. Considering the initial diagnosis of newborns and in order to emphasize the importance that all samples should have the same process in terms of time in education, and since the purpose of this study is to examine the outcome of developmental supportive care after discharge, educational sessions will begin from seven days before the possible time of infant's discharge , it will continue for five consecutive days and it will be every day and between the time period of eight in the morning and eight in the evening and in one of the rooms of the neonatal intensive care unit of Rouhani Hospital. Although the content of the day the mother was absent is taught on the next day, if the mother is absent two days in a row, she will be excluded from the study. It is obvious that if the infant dies during the study, it will be excluded from the study process. Mothers will be taught to check the weight, height and head circumference of infants one and two months after discharge on the prescribed days at the Rouhani hospital clinic. The height, weight and head circumference of the infants will be measured during admission to the ward by a trained nurse, who is not aware of the studied groups. After discharge, the height, weight and head circumference of the infants will be recorded by an experienced trained researcher who does not know about the study groups. The mother-infant attachment questionnaire will also be completed by mothers at the first meeting with the infant, at the time of discharge, and one and two months after discharge. It should be noted that the method of measuring height, weight and head circumference will be taught to the evaluators and will be measured by experienced people according to the correct measurement criteria. The mothers of intervention group will be taught in one of the empty rooms of the Neonatal Intensive Care Unit of Rouhani Hospital in a calm and quiet environment, and In order to prevent the possible data contamination of the studied groups, the mothers of the intervention group will be taught to have at least exchange of opinions and conversations about the topics they have been taught with other mothers.
Category
Other

2

Description
Control group: In the control group, the height, weight and head circumference of the infants will be measured at the time of birth and admission to the ward by a trained nurse, who doesn't know a bout studies group. One and two months after discharge, the height, weight, and head circumference of the infants will be recorded by an experienced trained researcher who does not know about the study groups. The mother-infant attachment questionnaire will also be completed by mothers at the first meeting with the infant, at the time of discharge, and one and two months after discharge. After the end of the study, if the mothers of the control group wish, training will be provided to the control group and the researcher will answer their questions and doubts after the discharge .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rouhani hospital
Full name of responsible person
Afsane Arzani
Street address
Ganj Afrouz Avn., Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/#

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Ganj Afrouz Avn., Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/#
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Afsane Arzani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ganj Afrouz Avn., Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0557
Email
a.arzani@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Afsane Arzani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ganj Afrouz Avn., Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0557
Fax
+98 11 3219 0181
Email
a.arzani@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/#

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Afsane Arzani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ganj Afrouz Avn., Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0557
Fax
+98 11 3219 0181
Email
a.arzani@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/#

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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
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