Determining the effect of using an octopus doll in reducing pain in premature babies hospitalized in the neonatal intensive care unit (NICU) and using it as a relatively easy and cost-effective method in the NICU
Design
80 infants are randomly entered into the intervention or control groups using the block randomization method. Blocks are determined based on a random allocation list using the site www.sealedenvelope.com. Pain scoring will be done by a trained nurse. After determining the baseline pain score in the first blood sampling, in the subsequent blood samplings, 5 minutes before the intervention, two cc of 50% dextrose is given to the infants. In the intervention group, the octopus doll is given to the infant before and after the blood collection and is placed next to the infant during the procedure.
Settings and conduct
This clinical trial will be conducted on premature babies who were born in BuAli Hospital in Sari and will be admitted to the NICU. Due to the nature of the octopus doll, which is given to the baby at the time of blood sampling, and the pain score is based on the changes in the baby's face, blinding is not applicable in this study.
Participants/Inclusion and exclusion criteria
Premature infants with a gestational age of less than 37 weeks, with a minimum birth weight of 500 grams, who are admitted to the NICU and require at least one blood sampling per day will be included in the study.
Intervention groups
In the intervention group, an octopus doll and feeding with 50% dextrose solution are used during blood sampling with a glucometer from the baby's heel.
In the control group, only feeding with 50% dextrose solution is used at the time of blood sampling with a glucometer from the baby's heel.
Main outcome variables
The main outcome of the study is the reduction of the average pain score in both intervention and control groups at the time of blood sampling.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230926059528N1
Registration date:2023-10-12, 1402/07/20
Registration timing:prospective
Last update:2023-10-12, 1402/07/20
Update count:0
Registration date
2023-10-12, 1402/07/20
Registrant information
Name
Shahrokh Mehrpisheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
sh.mehrpishe@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using octopus crochet doll in reducing pain score after blood sampling in premature infants
Public title
The effect of using octopus crochet doll in reducing blood sampling pain in premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age less than 37 weeks
Admission to the neonatal intensive care unit
Minimum birth weight of 500 grams
At least need blood sampling once a day
Exclusion criteria:
Congenital abnormalities such as heart, kidney or blood abnormalities or cancer
Performing surgery on the baby
The presence of disorders that require treatment with opioids, muscle relaxants, antiepileptic drugs, and analgesics
Birth trauma
Respiratory distress, pneumoperitoneum, atelectasis
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Neonates are randomly entered into each of the intervention or control groups using the block randomization method. Blocks are determined based on a random allocation list using www.sealedenvelope.com website (block of 4).
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 Mazandaran University of Medical Sciences
Street address
Vice chancellor for Research, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Approval date
2023-09-23, 1402/07/01
Ethics committee reference number
IR.MAZUMS.REC.1402.392
Health conditions studied
1
Description of health condition studied
Blood sampling pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
The average pain score of in two intervention and control groups
Timepoint
10 minutes before blood collection, during blood collection and 10 minutes after blood collection
Method of measurement
The Premature Infant Pain Profile (PIPP)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, an octopus doll and feeding with 50% dextrose solution are used during blood sampling with a glucometer from the infant's heel.
Category
Treatment - Other
2
Description
Control group: In the control group, only feeding with 50% dextrose solution is used at the time of blood sampling with a glucometer from the infant's heel.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina Hospital
Full name of responsible person
Dr. Shahrokh Mehrpisheh
Street address
Bu-Ali Sina Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
sh.mehrpishe@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mazandaran University of Medical Sciences
Street address
Vice chancellor for Research and Technology, Moallem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
p.ebrahimnezhad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Iran University of Medical Sciences
Full name of responsible person
Hani Rostami Rad
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Bu-Ali Sina Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
hanirostamirad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Roya Farhadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neonatology
Street address
Pediatric Infectious Diseases Research Center, Buali hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Fax
Email
r.farhadi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hani Rostami Rad
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Bu-Ali Sina Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
hanirostamirad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data is accessible
When the data will become available and for how long
Starting in January 2025
To whom data/document is available
Everybody
Under which criteria data/document could be used
Systematic review articles
From where data/document is obtainable
Contact Dr. Shahrokh Mehrpisheh: shahrokhmehrpisheh@yahoo.com
What processes are involved for a request to access data/document
After contact, information is sent within a few days