Studying the effect of light and sound stimulus modulation on pain caused by venous blood sampling in premature infants admitted to the neonatal intensive care unit.
Studying the effect of light and sound stimulus modulation on pain caused by venous blood sampling in premature infants admitted to the neonatal intensive care unit.
Design
A controlled clinical trial with parallel groups, consisting of two intervention groups and a control group, will be conducted in a randomized on 90 infants. Non-random sampling of the "available" type will be used to enter the study. They will be divided into three intervention groups: A, B, and a control group, using the random block method, using the site http://www.graphpad.com/quickcalcs/index.cfm.
Settings and conduct
In this study, 90 newborns with a gestational age of 28 to 32 weeks will be enrolled based on the newborn's medical records and admitted to the intensive care unit of Imam Khomeini Hospital in Dargaz. Blinding will not be performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: parental consent to participate in the intervention; preterm infant from 32 to 37 weeks according to the record. Exclusion criteria: use of analgesics and sleeping pills in the past 24 hours; infant Apgar score less than 6.
Intervention groups
In this study, we will have two intervention groups and a control group. The first intervention group: to modify the sound stimulus, an earplug will be placed on the infant 15 minutes before the procedure and will remain until 15 minutes after the procedure. The second intervention group: to modify the light stimulus, an eye mask will be placed over the infant's eyes 15 minutes before the procedure and will be removed 15 minutes after the blood draw. The control group: routine care will be provided during the blood draw.
Main outcome variables
Crying duration; Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211211053351N4
Registration date:2025-06-12, 1404/03/22
Registration timing:prospective
Last update:2025-06-12, 1404/03/22
Update count:0
Registration date
2025-06-12, 1404/03/22
Registrant information
Name
sadeghi tahereh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 7313
Email address
sadeghit@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-01, 1404/04/10
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of light and sound stimulus modulation on pain caused by venous blood sampling in premature infants admitted to the neonatal intensive care unit.
Public title
Study of light and sound stimuli on pain in newborns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Newborns with a gestational age of 28 to 32 weeks
Newborn hospitalization
Needing venous blood sampling
Exclusion criteria:
The infant's 5-minute Apgar score less than 6
Use of sedatives and hypnotics in the past 24 hours
Failed to obtain a vein during the first injection
Age
From 1 day old to 7 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method was utilized for allocating samples to two groups. To generate the random sequences, we used the website http://www.graphpad.com/quickcalcs/index.cfm. We employed six types of four-pair blocks as follows: AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), and BAAB (6). Thus, the allocation of samples to the two groups was carried out using the block randomization method, which helps enhance balance and reduce bias in the selection of samples.
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
Research Ethics Committees of School of Nursing & Midwifery - Mashhad University of Medical Sciences
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate ofFerdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-03-05, 1402/12/15
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.004
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Duration of baby's crying after opening an IV line
Timepoint
Immediately after injection
Method of measurement
By means of a timer
2
Description
Neonatal pain scale
Timepoint
During injection, after injection
Method of measurement
The Neonatal Pain, Agitation and Sedation Scale (N-PASS): is used to assess pain, agitation, and sedation in neonates. It consists of two scales: a pain/agitation scale and a sedation scale. The pain/agitation scale ranges from 0 to 10, with higher scores indicating greater pain or agitation. The sedation scale ranges from 0 to -10, with lower scores indicating deeper sedation.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To adjust the sound stimulus, an earmuff will be placed on the infant 15 minutes before the procedure and will remain on for 15 minutes after the procedure.
Category
Treatment - Other
2
Description
Intervention group: To adjust the sound stimulus, an earmuff will be placed on the infant's eye 15 minutes before the procedure and will remain on for 15 minutes after the procedure.
Category
Treatment - Other
3
Description
Control group: First, the injection site will be identified, cleaned with alcohol, and the catheter will be inserted.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dargaz Imam Khomeini Hospital, Razavi Khorasan Province
Full name of responsible person
Tahereh Sadeghi
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate ofFerdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3884 6730
Email
tahereh.sadeghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Deputy- Ghorashi Building- Next to Hoveyzeh Cinema- Daneshgah Street- Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
University grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School , Martyr Dr. Kharazmi Educational Building, University Campus, East Gate ofFerdowsi University of Mashhad, Azadi Square , Mashhad, Razavi Khorasan, Iran.
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
tahereh.sadeghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate ofFerdowsi University of Mashhad, Azadi Square
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
tahereh.sadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School , Shahid Dr. Kharazmi Educational Building, University Campus, East Gate ofFerdowsi University of Mashhad, Azadi Square
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
tahereh.sadeghi@yahoo.com
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