Objectives: The Effect of massage on preterm newborns has been shown in many studies, but has not been adequately studied in their mothers.This study will be undertaken to determine if infant massage will be decreased state anxiety or improved mood state in mothers of preterm newborns.
Design: In a semi experimental study, 70 Iranian mothers who will be discharged their preterm newborns from the Neonatal Intensive Care Unit (NICU) will be participated in this study. To avoid data transfer, sampling will be done for the control or intervention group within a week.
Participants: 70 Iranian mothers 18- 40 years old and singleton pregnancy with their preterm infants who are born at 32-37 weeks gestational age.
Exclusion criteria including the mother's unwillingness to continue participation in the trial and Re-hospitalization of neonate.
Intervention: Intervention will be done for mother-infant dyads in case group as 8 min massage session consisted of two identical standardized 4-min .The first 4 min will be involved the researcher demonstrating the massage and for the second 4 min, the mother will be performed the massage. Then interventions will be repeated in the day of discharge. No intervention will be done in control group.
Intervention: Using the palms of her hands, and with the infant in a prone position, she firmly stroked with moderate pressure for four 1-min periods (12 strokes at approximately 5 s per stroking motion) the infant’s head and the back in the following sequence: (1) from the top of the head to the neck and back to the top of the head; and (2) from the upper back to the waist and back to the upper back. The mother then repeated the same moderate pressure stroking procedure modeled by the researcher.
Main outcome: State anxiety and mood state.
The day before discharge, maternal state anxiety (MSA) will be measured using the State-Trait Anxiety Inventory (STAI) Scale (Spielberger) and will be measured mood state using The profile of mood states (POMS) .After intervention, the MSA will be re-measured using Spielberg’s and mood state scale for all mothers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305262324N10
Registration date:2014-03-25, 1393/01/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-25, 1393/01/05
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2013-06-24, 1392/04/03
Expected recruitment end date
2013-10-12, 1392/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage infant on state anxiety and mood state in mothers with preterm infants, discharged from the Neonatal Intensive Care Unit
Public title
The effect of massage infant on state anxiety and mood state in mothers with preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian singleton preterm infants with gestational age 32-37 weeks; no congenital anomalies; the newborn's discharge until next 24 hours; no history of mental health in mother; no history of addiction in mother
Exclusion criteria: The mother's unwillingness to continue participation in the trial; Re-hospitalization of neonate
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
no
Secondary trial Id
no
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitment of Tehran University of Medical Sciences
mild mental and behaviorl disorders associated with the puerperium , not elsewhere classified
Primary outcomes
1
Description
The State anxiety in mothers of preterm infants
Timepoint
The day before discharge and the day of newborn's discharge
Method of measurement
The State-Trait Anxiety Inventory (STAI) Scale (Spielberger)
2
Description
Effect on mother’s mood state
Timepoint
The day before discharge and the day of discharge infant
Method of measurement
The Profile of Mood States (POMS)(McNair)
Secondary outcomes
1
Description
no
Timepoint
no
Method of measurement
no
Intervention groups
1
Description
The intervention is provided the 8-min massage session consisted of two identical standardized 4-min segments. The first 4 min will be done by researcher and then the second 4 min, will be done by the mother. Using the palms of her hands, and with the infant in a prone position, she firmly stroked with moderate pressure for four 1-min periods (12 strokes at approximately 5 s per stroking motion) the infant’s head and the back in the following sequence: (1) from the top of the head to the neck and back to the top of the head; and (2) from the upper back to the waist and back to the upper back. The mother then repeated this massage for 4min
Category
Prevention
2
Description
Intervention Will not be done in the control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi treatment & education center
Full name of responsible person
Maryam Keshavarz
Street address
Molavi street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences