Effect of foot reflexology on a preterm newborn's pain and physiological parameters during leader flex
Design
Clinical trial with control group, with parallel groups, two-sided, randomized, without phase on 60 neonate.Random Allocation Software was used for randomization.
Settings and conduct
This research is a two-group clinical trial and is conducted on 60 premature neonate in Akbar Hospital's neonatal intensive care unit. Solar plexus sole reflex massage will be performed by the researcher for a total of 6 minutes. A pulse oxymeter will be placed on the babies right wrist, they will be monitored Heart rate, oxygen saturation, and breathing rate 5 minutes before, during and 1 minute after the operation will be recorded by the research assistant. The amount of pain in babies will also be recorded and checked by the help of the researcher using the NIPS tool when the needle enters.
Participants/Inclusion and exclusion criteria
Premature neonate with a gestational age of 28 to 37 weeks, 1 to 5 days old, who require hospitalization for more than 5 days.
Intervention groups
Control group neonate are swaddled 30 minutes before Leader Flex insertion.
In addition to swaddling, neonate in the intervention group receive foot massage.
Main outcome variables
in, heart rate, breathing rate, blood oxygen level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231224060513N1
Registration date:2024-06-03, 1403/03/14
Registration timing:prospective
Last update:2024-06-03, 1403/03/14
Update count:0
Registration date
2024-06-03, 1403/03/14
Registrant information
Name
somayeh Bagherzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
bagherzadehs4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2024-11-10, 1403/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of foot reflexology on a preterm newborn's pain and physiological parameters during leader flex
Public title
foot reflexology on a preterm newborn's pain and physiological parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parents have informed consent to participate in the intervention.
neonatal 28-37 weeks, 1-5 days old, who need hospitalization for more than 5 days
Before intervention, the neonate should be awake
The duration of the Leader-flex embedding process should not last more than 20 minutes
Exclusion criteria:
Parents' lack of consent to continue the research
Failure to open a vein for the first time
The duration of the Leader-Flex installation process takes more than 20 minutes
Age
From 196 days old to 259 days old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this way, the allocation of samples to the intervention or control groups will be done by random allocation (lottery using block design).
First, by giving codes to the groups, group A: foot reflex massage and group B is the control 4 blocks of 4 are specified: ABAB (1) - AABB (2) - BBAA (3) - BABA (4) -and; finally, the treatment allocation list will be determined based on "random allocation software" and the previous steps will continue until the end of sampling.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, neonate and parents of neonate, as well as researchers or outcome assessors, are unaware of the allocation of study groups.The baby's parents are fully aware of the study and intervention and they are satisfied, but they do not know whether the intervention will be done on their baby or not.Assessors who collect data from 60 infants have information about which infants the intervention was performed on.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Nursing and Midwifery Faculty of Mashhad University of Medical Sciences
Street address
Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-03-05, 1402/12/15
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.003
Health conditions studied
1
Description of health condition studied
Investigating the effect of foot reflexology massage on the amount of pain caused by leader flex insertion in preterm babies.
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Investigating the effect of foot reflexology massage on the number of heartbeats caused by Leader flex implantation in preterm infants.
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Investigating the effect of foot reflexology massage on the number of breaths caused by Leader flex insertion in preterm infants.
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Investigating the effect of foot reflexology massage on blood oxygen level caused by Leader flex insertion in preterm babies.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Neonatal pain measurement with the NIPS scale
Timepoint
Measurement of pain in 5 minutes before, during and 1 minute after Liderflex installation.
Method of measurement
NIPS (Neonatal Infant Pain Scale)To measure pain and vital signs monitoring device to measure heart rate, breathing rate and blood oxygen level.
2
Description
Measurement of physiological parameters
Timepoint
Measurement of physiological parameters in 5 minutes before, during and 1 minute after installation of Leaderflex.
Method of measurement
Vital signs monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Reflex massage of the soles of the solar plexus (which is located at the junction of the anterior third and the posterior two thirds of the sole in the mid line, which is located just below the protrusion of the sole) and the heart area (the center of which is between the necks of the 4th and 5th metatarsals of the left foot somehow It is located where its upper surface is covered by the lung area and its lower surface is covered by the spleen area) and the kidney area (the size of a knuckle on the sole of the foot just below the adrenal area) in the left leg and the area of the solar plexus and kidney and adrenal (if the border between Consider the pads under the thumb and other toes as a vertical line of the letter T, and consider the base of these pads as a transverse section and consider an inverted T, this reflective area in the posterior recess up to the intersection point in the T lying on the sole of the foot, between the neck of the bone. The second and third metatarsals are placed on the sole of the foot) on the right foot for 3 minutes in each foot for a total of 6 minutes, each area will be massaged for 1 minute with the fist-propping technique of the index finger on the lateral part of the distal tendon of the finger by the researcher.
Category
Prevention
2
Description
Intervention group: Babies will be swaddled for 30 minutes before the start of the Leader Flex installation process.
Category
Prevention
3
Description
Control group: Babies will be swaddled for 30 minutes before the start of the Leader Flex installation process.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar hospital
Full name of responsible person
Tahereh Sadeghi
Street address
Shahid Kaveh Blvd,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Email
ak.pr@mums.ac.ir
Web page address
https://akbar.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
Daneshgah Ave,GHoreyshi Bldg,Vice President of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
sadeghit@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad,Mashhad Town
City
Mashhsd
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Web page address
https://mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Web page address
https://mums.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
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