The effect of massage by mothers on the baby's weight and perceived Self-efficacy of mothers who have low birth weight babies in neonatal intensive care unit
The effect of maternal infant massage on neonatal weights and perceived self-efficacy of mothers with low birth weight infants.
Design
The present study is a semi-experimental clinical trial. There is a control group.
Sampling was done randomly and blocked. The sample size in each intervention group was 40 and control group.
Settings and conduct
This is a quasi-experimental clinical trial. Research environment
Using random allocation, two hospitals are selected as intervention and control in educational centers in Ahwaz. In the intervention group, the babies are given massage for sixty days. The control group is only routine care.
Participants/Inclusion and exclusion criteria
Maternal entry criteria:
- The mother of Iran, the presence of the mother with the baby in all the days prescribed for massage, mothers of drugs and alcohol addiction is not addictive.
- The mother has no contagious skin disease in her hands.
- Mother's pregnancy is wanted on its own.
Neonatal Criteria:
- The baby is asked for a pregnancy, the birth weight of the infant is 2499-1500 grams.
- The gestational age of babies is between 30 and 36 (32) weeks. The incidence of intrauterine gestational age is considered to be 32 weeks, however, if the number of babies born in 32 weeks is low, neonates will be sampled from 30 to 36 weeks.
- The baby has no contagious skin disease and genetic and congenital anomalies.
- The baby has constant clinical conditions.
- The baby does not have an interventional treatment such as chest tube and surgery.
- At least ten days in hospital.
Intervention groups
The baby's intervention group is massaged for sixty days by the mother who has been trained. In the control group, mothers and infants will receive only the usual care of the department.
Main outcome variables
Baby weight gain and self-efficacy of mothers with low birthweight.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090405001788N19
Registration date:2018-04-08, 1397/01/19
Registration timing:registered_while_recruiting
Last update:2018-04-08, 1397/01/19
Update count:0
Registration date
2018-04-08, 1397/01/19
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage by mothers on the baby's weight and perceived Self-efficacy of mothers who have low birth weight babies in neonatal intensive care unit
Public title
The effect of massage by mothers on the baby's weight and perceived Self-efficacy of mothers who have low birth weight babies in neonatal intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Neonatal Criteria:
The baby is asked for a pregnancy.
The birth weight of the infant is 2499-1500 grams
The gestational age of the infants is between 30 and 36 (32) weeks.
The baby has no contagious skin disease and genetic and congenital anomalies.
The baby has constant clinical conditions.
The baby does not have an interventional treatment such as chest tube and surgery.
At least ten days in hospital.
Maternal Entry Criterion:
The presence of the mother with the baby on all the days prescribed for massage.
Mother of iran.
Mother has no contagious skin disease in her hands.
Pregnancy is your mother's will.
Mothers are not addicted to drugs and alcohol.
Exclusion criteria:
Age
To 60 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation, two hospitals in Ahvaz educational centers will be selected as intervention and control, then newborns with entry criteria will be studied.
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 Iran University of medical Seinces
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-12-26, 1396/10/05
Ethics committee reference number
IR.IUMS.REC1396.9411451012
Health conditions studied
1
Description of health condition studied
Premature infants
ICD-10 code
P07.1
ICD-10 code description
Other low birth weight newborn
Primary outcomes
1
Description
Baby weight
Timepoint
Weight gain on days 3, 10 and 60.
Method of measurement
Weight of newborns using the German Seca digital scale with a precision of 10 ± g.
2
Description
Self-efficacy of mothers with preterm infants
Timepoint
At the end of the 2nd month of the baby
Method of measurement
Farsi version of the Self-efficacy Questionnaire (PMP S-E) Barnes and Adamson-Macedo (2007) will use maternal self-efficacy measurements.
Secondary outcomes
empty
Intervention groups
1
Description
In order to evaluate the effect of massage on weight loss in low birthweight and self-efficacy of mothers, massage will be performed for 60 days. Sampling is done in randomized blocks and participants will be asked to fill out the informed consent form, then the mothers who will be satisfied with the participation in the study will be selected. Interviews include: a) Presenting a booklet And a training DVD that is provided by the Neonatal Health Department and the Ministry of Health and Medical Education, 2015, with the collaboration and participation of the Neonatal Health Department of the Ministry of Health and Medical Education (Massage of Infants and Infants). It should be noted that the way the massage steps are performed on the DVD will be explained by the researcher in a comprehensible language for mothers. B) Presentation of massage training for mothers; c) conducting 2 one-hour training sessions by the researcher; d) practicing a mother in the presence of a researcher on a simple neonatal model that is available for routine training at the nursing school. An occupational therapist, along with a researcher, will be available to massage and confirm the correct way of massage at all stages of massage. If the mother needs more sessions and more hours for massage training, these trainings will be continued by the researcher until a proper massage is completed. Performing good massage and ensuring that all mothers have the right impression of massage therapy will be controlled by the researcher and occupational therapist through the observation of the massage performed by the moms on the moth. In all phases of film play for massage therapy and practical massage practice, the researcher will be presenting more explanations and solving the problems and questions of mothers along with them. The researcher's contact number is also available to answer questions from mothers 24 hours a day. Massage from the head to the tip of the baby while the baby's body is uncovered or if it has only a cover. Each mother will massage her baby with olive oil for 15 minutes (used for all samples of a commercial type), the study will continue for 60 days.
Category
Behavior
2
Description
In the control group, mothers and newborns will receive only the usual care of the department (these include: physician's examination, daily weighting of the baby, drug therapy, serum therapy, training on the correct breast feeding to mothers, controlling the absorption and excretion of the baby, training and follow up Vaccination, training for the discharge of the baby and assessment of the correct nutrition of the infant).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeyni hospital
Full name of responsible person
Dr.Kambiz Masomi
Street address
Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
06193673111
Phone
+98 61 3222 2922
Fax
+98 61 3222 5763
Email
himam@ajums.ac.ir
Web page address
http://himam.ajums.ac.ir
2
Recruitment center
Name of recruitment center
Abozar hospital
Full name of responsible person
Dr. Mehran Hakimzadeh
Street address
Pasdaran Highway
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 9003
Fax
+98 61 3444 4711
Email
aboozar-hos@ajums.ac.ir
Web page address
http://haboozar.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Seyed Kazem Malakoti
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
+98 21 8820 1488
Email
PR@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Leili Borimnejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi St..
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1708
Fax
+98 21 8820 1488
Email
borimnejad.l@iums.ac.ir
Web page address
htpp://fnm.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Leili Borimnejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi St.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1708
Fax
+98 21 8820 1488
Email
borimnejad.l@iums.ac.ir
Web page address
htpp://fnm.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Leili Borimnejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mirdamad
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1708
Fax
+98 21 8820 1488
Email
borimnejad.l@iums.ac.ir
Web page address
htpp://fnm.iums.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
Not applicable
Title and more details about the data/document
After Data coding In order to keep confidentiality of the participants in the research
When the data will become available and for how long
the end of sampling till six month after article publishing.
To whom data/document is available
ethical , reviewer and editorial committees, researchers
Under which criteria data/document could be used
systematic review and meta analysis or secondary analysis
citation
From where data/document is obtainable
Leili Borimnejad , borimnejad.l@iums.ac.ir
What processes are involved for a request to access data/document
After sending request by academic email, we will send them data files up to one week.