Comparison of the effect of massage compared to regular bedtime routines on the sleep status of 15-20 day old infants and the quality of sleep of their mothers
Determining infant massage on the infant and mother's night sleep status
Design
The present study is a clinical trial with a control group , single blind randomized on 140 neonates.
The randomization process will be a lottery with a card.
Settings and conduct
An information form will be filled out for all eligible people selected from the postpartum ward of Imam Ali Hospital in Amol. For the experimental group, the infant massage method will be explained and an instructional video on how to massage and instructions related to filling out the questionnaire will be given, and the control group will be given explanations and videos related to how and when to fill out the questionnaire. Individuals in both control and intervention groups completed the infant and mother sleep status questionnaire for 1 week without any intervention. Breastfeeding will be done. The control group will perform only the usual measures before going to bed and after starting the intervention at the end of the first and second week, both groups will fill in the questionnaire again.
Assessment of maternal and infant sleep status is done with the help of a separate researcher who does not know the allocation of groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Term singleton infants , birth weight 2500-4000 g
exclusive breastfeeding,
Exclusion criteria: no history of hospitalization of the infant due to illness,lack of obvious diseases or abnormalities of infant mother does not suffer from postpartum depression
Intervention groups
For the intervention group, a two-week period of massage 15 minutes before bedtime is performed, in addition to the usual pre-sleep procedures such as changing diapers, breastfeeding. For the control group, only the usual pre-sleep procedures are performed as above .
Main outcome variables
the sleep status of infants and mothers at night
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140924019277N3
Registration date:2022-01-17, 1400/10/27
Registration timing:retrospective
Last update:2022-01-17, 1400/10/27
Update count:0
Registration date
2022-01-17, 1400/10/27
Registrant information
Name
Sussan Saatsaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4422 1919
Email address
s.saatsaz@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-05-31, 1400/03/10
Actual recruitment start date
2020-11-22, 1399/09/02
Actual recruitment end date
2021-07-01, 1400/04/10
Trial completion date
2021-07-01, 1400/04/10
Scientific title
Comparison of the effect of massage compared to regular bedtime routines on the sleep status of 15-20 day old infants and the quality of sleep of their mothers
Public title
The effect of massage on the sleep status of infants and mothers
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
all healthy newborn
breastfeed exclusively
singleton
The first child
weight 2500-4000 gr
healthy mothers
No postpartum depression Taking antidepressants
Exclusion criteria:
Sick babies need treatment
formula feeding
anomali
Age
From 15 days old to 20 days old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
140
More than 1 sample in each individual
Number of samples in each individual:
2
Mother and her newborn
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The card drawing technique was used to randomize the assignment of subjects to the groups. A total of 140 identical cards were first prepared and 70s were labeled A (routine night time ), 70 B( newborn massage ). A card was randomly drawn for each participant who entered the study by an independent assistant researcher (engaged only in the randomization process) and the type of intervention written on the card was announced by another researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
Randomization process and assessment of the form of maternal and infant sleep status is performed by the researcher without the knowledge of the allocation of groups
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandran university of medical sciences
Street address
Sari-serah joibar
City
Sari
Province
Mazandaran
Postal code
4615861467
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.MAZUMS.REC.1398.545
Health conditions studied
1
Description of health condition studied
infant sleep condition and mother sleep quality
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maternal sleep quality score
Timepoint
From 7 days before the intervention, the end of the first week and the end of the second week of the intervention
Method of measurement
The Pittsburgh sleep quality index
2
Description
Infant sleep status markers
Timepoint
From 7 days before the intervention, the end of the first week and the end of the second week of the intervention
Method of measurement
The Brief Infant Sleep Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group :Massage the baby before going to bed every night for 2 weeks, 15 minutes each time, plus the usual bedtime interventions such as changing diapers and breastfeeding.Massaging the infant would be done in three 5-minute cycles. At first and to prevent skin friction, the mother would moisturize her hands with baby lotion and begin massaging according to the following procedures:1. In the first 5 minutes, the mother would lay the baby on the stomach, and the massage would begin by applying, in a pat-like manner, moderate pressure on the head, shoulders, back, arms, and legs (each part would be massaged for 6-10 seconds).2. In the second cycle, the baby would be laid on the back for 5 minutes, and the arms and legs would be first given ten extensions and flexions on their own, then both hands and feet.3. In the third 5 minutes, a massage would be given in similar conditions to the first 5 minutes.
Category
Other
2
Description
Control group: Common bedtime interventions such as diaper changes and breastfeeding
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital in Amol
Full name of responsible person
Sussan Saatsz
Street address
Serah Joibar
City
Srie
Province
Mazandaran
Postal code
4615861467
Phone
+98 11 4422 1919
Email
s.saatsaz@mazums.c.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
majid saeedi
Street address
Serah Joibr
City
Sri
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 4422 1919
Email
publicrel@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
sussan saatsaz
Position
Midwifery phd student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery of Amol,Mazandaran University of Medical Sciences, Sari, Iran
City
Amol
Province
Mazandaran
Postal code
579692442
Phone
+98 11 4422 1919
Fax
Email
s.saatsaz@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
sussan saatsaz
Position
, Faculty of Nursing and Midwifery of Amol, Mazandaran University of Medical Sciences, Sari, Iran
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
, Faculty of Nursing and Midwifery of Amol, Mazandaran University of Medical Sciences, Sari, Iran
City
sari
Province
Mazandaran
Postal code
0579692442
Phone
+98 11 4422 1919
Fax
Email
s.saatsaz@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sussan Saatsaz
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Sari Serahe Joybar
City
Sari
Province
Mazandaran
Postal code
4615861467
Phone
+98 11 4422 1919
Fax
+98 11 4415 1222
Email
s.saatsaz@mazums.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