Protocol summary
-
Study aim
-
To examine the effect of skin to skin (STS) contact on first IM injection pain in newborns
-
Design
-
Randomized controlled single blind clinical trial in newborns with a sample size of 60.
-
Settings and conduct
-
Place of the study: Zeynep Kamil Hospital, Itanbul.
Blinding method and process: In the intervention group, the mothers (and their babies) will not be informed about why IM injection is administered during STSC.
-
Participants/Inclusion and exclusion criteria
-
Inclusion: Literate mother, Mother aged between 18-35 years, Mother giving birth to between 37-41 weeks of gestation, Mother having no chronic disease, Mother delivering her baby in a cephalic position, Mother giving birth through vaginal delivery, Mother having no mental or psychological problem, Newborn having 1st-minute APGAR score of 7 or above, Newborn weighing 2500-4000 gr.
Exclusion: Mother having breech delivery, having kiwi, vacuum and forceps-assisted delivery, Multiparous,
having an APGAR score of 7 or above after any intervention, needing to be observed in the intensive care unit, having congenital anomaly, receiving oxygen treatment, rejecting skin to skin contact after birth
-
Intervention groups
-
Intervention Group: Vitamin K will be IM administered from the left leg of newborn at 6th minute after STS. The STS contact procedure will be continued after IM injection. Pain, oxygen saturation, and cardiac apex beat will be assessed in newborn before STS contact (I), at 5th minute of the contact ( II), at 5th minute after injection ( III) and 5 minutes after the end of STS contact ( IV). Control group. STS contact will not be applied. Routine clinical practices will be continued.
-
Main outcome variables
-
Pain,
Duration of crying
General information
-
Reason for update
-
We applied with the public title " The effect of postpartum skin to skin contact on the pain of first -Intramuscular injection to a newborn" However, we changed the public title to "The effect of skin to skin contact on first IM injection pain in newborns" in line with the criticism from you. But we got the institution and ethical permission with the first title we uploaded to the system. These heading differences are stated by the institutions as a problem.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200115046139N1
Registration date:
2020-04-24, 1399/02/05
Registration timing:
prospective
Last update:
2020-06-24, 1399/04/04
Update count:
1
-
Registration date
-
2020-04-24, 1399/02/05
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-05-01, 1399/02/12
-
Expected recruitment end date
-
2021-05-01, 1400/02/11
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Comparison of the Response To First-Intramuscular (IM) Injection Pain In Newborns With And Without Skin To Skin Contact
-
Public title
-
The Effect of Postpartum Skin to Skin Contact on the Pain of First Intramuscular Injection to Newborn
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Literate mother and her newborn infant
Mother aged between 18-35 years and her newborn infant
Mother giving birth to between 37-41 weeks of gestation and her newborn infant
Mother having no chronic disease and her newborn infant
Mother delivering her baby in a cephalic position and her newborn infant
Mother giving birth through vaginal delivery and her newborn infant
Mother having no mental or psychological problem and her newborn infant
Newborn having 1st-minute APGAR score (scoring system indicating health of newborn) of 7 or above and mother
Newborn weighing 2500-4000 gr and mother
Exclusion criteria:
Mother having breech delivery and her newborn infant
Mother having kiwi, vacuum and forceps-assisted delivery and her newborn infant
Multiparous mother and her newborn infant
Newborn having an APGAR score of 7 or above after any intervention and mother
Newborn needing to be observed in the intensive care unit and mother
Newborn having congenital anomaly and mother
Newborn receiving oxygen treatment and mother
Mother rejecting skin to skin contact after birth and her newborn infant
-
Age
-
From 1 day old to 1 day old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Block randomization will be used. Newborns and their mothers will be assigned to intervention and control groups through block randomization (block size of three). MedCalc program will be used to determine order of randomization.
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
The mother and baby will not be informed about why skin-to-skin contact occurs
-
Placebo
-
Not used
-
Assignment
-
Single
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-12-04, 1398/09/13
-
Ethics committee reference number
-
107
Health conditions studied
1
-
Description of health condition studied
-
Pain of First Intramuscular Injection to Newborn
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Pain
-
Timepoint
-
Before the procedure, the 5th minute before the procedure, the 10th minute after the procedure, and the 15th minute after the procedure
-
Method of measurement
-
Neonatal Infant Pain Scale (NIPS)
2
-
Description
-
Crying time
-
Timepoint
-
Before the procedure, the 5th minute before the procedure, the 10th minute after the procedure, and the 15th minute after the procedure
-
Method of measurement
-
Crying time will be evaluated by timer.
Secondary outcomes
1
-
Description
-
Cardiac apex beat
-
Timepoint
-
Before the procedure, the 5th minute before the procedure, the 10th minute after the procedure, and the 15th minute after the procedure
-
Method of measurement
-
Cardiac apex beat and saturation shall be recorded through a pulse oximeter probe
2
-
Description
-
Oxygen saturation
-
Timepoint
-
Before the procedure, the 5th minute before the procedure, the 10th minute after the procedure, and the 15th minute after the procedure
-
Method of measurement
-
Oxygen saturation shall be recorded through a pulse oximeter probe
Intervention groups
1
-
Description
-
Experimental Group: When the baby is born, she/he shall be taken under the radiant heater at the mother’s room, the umbilical clamp shall be put, and the umbilical care shall be provided. After the mother and her baby wear a bracelet, the nappy shall be fastened, the baby cap shall be placed, the baby shall be covered with a preheated cover, and the STSC of the mother and her baby shall be provided. Before the mother takes the baby on her lap, the pulse oximeter probe shall be put on the right hand, and the cardiac apex beat and saturation shall be recorded through this method. Then, the NIPS (Neonatal Infant Pain Scale) shall be applied for pain assessment. The duration of crying, pain, cardiac apex beat and saturation shall be recorded before the STSC. when the baby is taken on her mother’s lap, the duration of crying, pain, cardiac apex beat and saturation shall be recorded after 5-minute STSC. Vitamin K support shall be given from the left leg, intramuscularly. After the Vitamin K support and additional 5-minute STSC, the duration of crying, pain, cardiac apex beat and saturation shall be recorded. After 10-minute STSC in total, the baby shall be taken under the radiant heater. After 5-minute observation under the radiant heater, the duration of crying, pain, cardiac apex beat and saturation shall be recorded, and the procedure shall be ended.
-
Category
-
Behavior
2
-
Description
-
Control group: When the baby is born, s/he shall be taken under the radiant heater at the mother’s room, the umbilical clamp shall be put, and the umbilical care shall be provided. After the mother and her baby wear a bracelet, the nappy shall be fastened, and the baby shall stay under the radiant heater. The pulse oximeter probe shall be put on the right hand, and the cardiac apex beat and saturation shall be recorded through this method. Then, the NIPS (Neonatal Infant Pain Scale) shall be applied for pain assessment. The duration of crying, pain, cardiac apex beat and saturation shall be recorded before STSC. After 5-minutes, Vitamin K support shall be given intramuscularly from the left leg immediately after recording of pain, cardiac apex beat and saturation. 5-minutes later, the duration of crying, pain, cardiac apex beat and saturation shall be recorded.
-
Category
-
N/A
1
-
Sponsor
-
-
Grant name
-
none
-
Grant code / Reference number
-
none
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Faculty of Health Sciences, University of Health 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
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