Comparing the effect of swaddling and facilitated tucking position on pain intensity and changing in Physiological parameters of premature infants during non-invasive application with NCPAP
Comparing the effect of swaddling and facilitated tucking position on pain intensity and changes in Physiological parameters of premature infants during non-invasive application with NCPAP
Design
Premature infants hospitalized in the cardiac intensive care unit between 28 and 32 weeks were randomly assigned to one of three groups: swaddling, fetal position, and control. In all three groups, variables of pain intensity, heart rate, and percentage of oxygen saturation were measured before the start of the study. Then, after random allocation to the study groups, pain intensity, pulse, and oxygen saturation percentage were measured during nasal tube insertion, after the nasal tube was fixed, and every half hour for up to two hours.
Settings and conduct
Neonatal intensive care unit of Kamali's hospital inN Karaj, Iran
Participants/Inclusion and exclusion criteria
Premature newborns between 28 to 32 weeks of gestational age
Inclusion criteria: APGAR score higher than 7; birth weight between 1000 to 2000 gr.
Exclusion criteria: Asphyxia during delivery; Addiction in newborn's mother
Intervention groups
Groups of study:
1. Swaddling
2. Facilitated tucking positioning
3. Control group
Main outcome variables
1. Pain intensity due to nasal tube for NCPAP mode
2. Heart rate
3. Spo2 saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101108005134N14
Registration date:2023-04-18, 1402/01/29
Registration timing:prospective
Last update:2023-04-18, 1402/01/29
Update count:0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Ali Fakhr-Movahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4192
Email address
Alimovi49@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-29, 1402/02/09
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of swaddling and facilitated tucking position on pain intensity and changing in Physiological parameters of premature infants during non-invasive application with NCPAP
Public title
Comparing of swaddling and facilitated tucking positioning on pain intensity of preterm newborns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
APGAR score higher than 7
Birth weight between 1000 to 2000 gr
Newborn's parent consent
Exclusion criteria:
Perinatal asphyxia
Congenital anomalies in newborn
Addiction of newborn's mother
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the study, infants are divided into swaddle, facilitated tucking position, and control groups based on a 6-block randomized design. The randomization unit is individual. The number of infants in each of the three groups is equal. Randomization will be done by https://www.sealedenvelope.com.
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 commitee of Semnan university of medical sciences
Street address
Basij Blvd; The central headquarters of the mobilization of the Boulevard, Semnan University of medical sciences, Vice President for research and technology
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.SEMUMS.REC.1402.001
Health conditions studied
1
Description of health condition studied
Premature neonate
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Pain intensity
Timepoint
Beginning of the study, during insertion of the nasal tube, after fixation of the nasal tube, every 30 minutes until 2 hours.
Method of measurement
Neonatal Infant Pain Scale
2
Description
Heart rate
Timepoint
Beginning of the study, during insertion of the nasal tube, after fixation of the nasal tube, every 30 minutes until 2 hours.
Method of measurement
Pulse oximeter
3
Description
O2 saturation percent
Timepoint
Beginning of the study, during insertion of the nasal tube, after fixation of the nasal tube, every 30 minutes until 2 hours.
Method of measurement
پالس اکسی متر
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: swaddling, so that the infant is completely wrapped in a thin rectangular blanket. In this case, only the infant's head and neck are out of the swaddle.
Category
Treatment - Other
2
Description
Intervention group: facilitated tucking position, which includes keeping the infant's arms and legs in a flexed position, head and legs gathered towards the abdomen, and in a lateral lying position.
Category
Treatment - Other
3
Description
Control group: routine actions, that infant is receive routine's care
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Dr. Maryam Hashemnejad
Street address
Shohada Sq. Kamali St. Kamali Hospital, Karaj
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 3021
Email
Kamali@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid Mirmohammadkhani
Street address
Basij Blvd, Semnan University of Medical Sciences, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ali Fakhr-Movahedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kilometer 5, Damghan road, Nursing and allieh health faculty, Semnan university of medical sciences, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4192
Email
Alimovi49@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Fakhr-Movahedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kilometer 5, Damghan road, Nursing and allieh health faculty, Semnan university of medical sciences, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4192
Fax
Email
Alimovi49@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Fakhr-Movahedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kilometer 5, Damghan road, Nursing and allieh health faculty, Semnan university of medical sciences, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
009833654192
Email
Alimovi49@semums.ac.ir
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