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
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046139N1
Registration date:2020-04-24, 1399/02/05
Registration timing:prospective
Last update:2020-04-24, 1399/02/05
Update count:1
Registration date
2020-04-24, 1399/02/05
Registrant information
Name
Leyla Kaya
Name of organization / entity
Faculty of Health Sciences, University of Health Sciences Turkey
Country
Turkey
Phone
+90 216 418 96 16
Email address
leylakaya02@gmail.com
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 skin to skin contact on first IM injection pain in newborns
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
Participant
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Clinical Research Ethics Committee of Zeynep Kamil Women's and Children's Diseases Training and Rese
Street address
Op. Dr. Burhanettin Üstünel street No: 10 Üsküdar
City
Istanbul
Postal code
34668
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
Full name of responsible person
Neriman Zengin
Street address
Op. Dr. Burhanettin Üstünel street No: 10 Üsküdar
City
Istanbul
Postal code
34668
Phone
+90 216 391 06 80
Fax
+90 216 391 06 90
Email
zkhetikkurulsekreterya@gmail.com
Web page address
https://zeynepkamilkdch.saglik.gov.tr/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Health Sciences, University of Health Sciences