Investigating the effect of non-nutritive feeding and olfactory stimulation with breast milk on pain and behavioral responses caused by PICC implantation in premature infants.
Determining the effect of non-nutritive feeding and olfactory stimulation of breast milk on pain and behavioral responses caused by peripheral central catheter implantation of premature infants hospitalized in the neonatal intensive care unit
Design
Sample selection is done in such a way that all the qualified samples are listed, then each of them is given a number that is set by chance. There was no particular order in writing these numbers. In the following, the necessary number of samples will be randomly selected from among the numbers. In replacing people in the control and intervention groups, the method of randomly transformed blocks is used. In this way, the samples eligible to enter the study are selected and randomly placed in two intervention and control groups
Settings and conduct
NICU research site, Imam Khomeini Hospital, Ahvaz
Pain in these babies will be measured in three stages before, during and after the intervention using the PIPP tool.
20 seconds to evaluate behavioral indicators
30 seconds to evaluate physiological indicators
Participants/Inclusion and exclusion criteria
Inclusion criteria: the gestational age is at least 28 weeks and at most 36 weeks and 6 days; birth weight above 1500 grams; mother's willingness to participate in the study; stability of clinical and physiological status. Non-entry criteria: refusal of parents to sign the consent form; use of peripheral IV catheters.
Intervention groups
2 minutes before PICC insertion, a 2 x 2 cm cotton ball containing 2.5 ml of breast milk is placed 3 cm from the baby's nose.
. In order to perform non-nutritive sucking, a pacifier suitable for the baby's mouth size is used 5 minutes before PICC insertion.
In the control group, pain is measured 2-3 minutes before PICC insertion, during work and 30 seconds after.
Main outcome variables
Reducing pain and modulating behavioral responses
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230724058904N2
Registration date:2023-08-08, 1402/05/17
Registration timing:prospective
Last update:2023-08-08, 1402/05/17
Update count:0
Registration date
2023-08-08, 1402/05/17
Registrant information
Name
sara Faramarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3225 7028
Email address
sara.faramarzi.1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of non-nutritive feeding and olfactory stimulation with breast milk on pain and behavioral responses caused by PICC implantation in premature infants.
Public title
Investigating the effect of non-nutritive feeding and olfactory stimulation with breast milk on pain and behavioral responses caused by PICC implantation in premature infants.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infants admitted to the NICU and requiring intravenous (IV) therapy through a PICC
The need for TPN or antibiotic therapy for at least 7 days and infants with 1 poor or difficult venous access
Birth weight above 1500 grams
Absence of mother's addiction and use of drugs related to epilepsy and neuropsychiatric disorders
Mother's desire and consent to participate the baby in the study
The stability of the clinical and physiological condition of the baby
No mechanical ventilation
The absence of central nervous system damage, convulsions and other cases), congenital anomalies, genetic and metabolic disorders based on the patient's file
The baby has an order to fix PICC.
Exclusion criteria:
Patients for whom central access has already been fixed
Use of peripheral IV catheters and umbilical cord catheters or surgically implanted catheters
Significant change in hemodynamic stability and restlessness
Age
From 7 months old to 9 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Sample selection is done in such a way that all eligible samples are listed, then each of them is given a number that is set according to coincidence.
There was no particular order in writing these numbers.
In the following, the necessary number of samples will be randomly selected from among the numbers.
In replacing people in the control and intervention groups, the method of randomly transformed blocks is used.
In this way, the samples eligible to enter the study are selected and randomly placed in two intervention and control groups.
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 Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Esfand St., Golestan Boulevard
City
ahvaz
Province
Khouzestan
Postal code
15794- 61357a
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.AJUMS.REC.1402.211
Health conditions studied
1
Description of health condition studied
Pain in premature babies
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
2
Description of health condition studied
Premature infants
ICD-10 code
P05.0
ICD-10 code description
Premature infants
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention - during the intervention - and up to 30 seconds after the intervention
Method of measurement
PIPP tool
Secondary outcomes
1
Description
Behavioral responses
Timepoint
Before the intervention - during the intervention - and up to 30 seconds after the intervention
Method of measurement
PIPP tool
Intervention groups
1
Description
Intervention group: After wearing a clean gown, wash your hands and arms completely with antimicrobial cleaning materials for three minutes. Then warm your hands with a warmer to get the right temperature. The researcher must make sure that no painful procedures and other pain relieving interventions have been performed 30 minutes before the PICC insertion and the implementation of interventions to prevent bias in the conclusions. Also, the mother was present at the baby's bedside half an hour before. No nutrition has been done. PICC insertion will be done by one of the trained and experienced and licensed personnel in the department. 2 minutes before PICC insertion, a 2 x 2 cm cotton ball containing 2.5 ml of breast milk is placed 3 cm from the baby's nose. The breast milk used in the intervention group was from their own mother, milked by hand and collected before breakfast to avoid the effect of food consumption on its smell, and then frozen. And it is heated to room temperature before intervention and used. In order to perform non-nutritive sucking, a pacifier suitable for the size of the baby's mouth is used 5 minutes before the insertion of the PICC. It should be noted that premature babies admitted to the special department for babies of Imam Khomeini Hospital are continuously under heart monitoring and pulse oximetry. And with continuous measurement of vital signs and indicators such as breathing rate and breathing depth - breathing sounds and breathing patterns - pulse quality and checking for symptoms of respiratory distress including jumping of nasal fins - retraction and increased breathing rate and also according to the history of the disease And the current condition of the patient can estimate the stability of the clinical and physiological condition. Pain in these babies will be measured in three stages before, during and after the intervention using the PIPP tool. Considering that PIPP evaluates the behavioral and physiological indicators of the baby, therefore, the time required to observe the behavior of the baby is 20 seconds and the behavioral and physiological indicators are considered 30 seconds.
Category
Rehabilitation
2
Description
Control group: The method of doing work in the control group is that 2-3 minutes before PICC insertion, during work and 30 seconds after, pain is measured. Parallel to the intervention group, pain score and physiological and behavioral indicators will be measured in the control group using PIPP.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Special Care Department of Imam Khomeini Hospital, Ahvaz
Full name of responsible person
Nahid Naseri
Street address
Imam Khomeini Medical Education Center, Azadegan St.