Effect of local heat on the pain severity due to urine bag removal in the preterm newborns
Design
This is a phase 2 clinical trial study with the control group and one blinded. The groups of the study are paralleled. The sample size for each group is 30 newborns. The newborns are assigned to each group by permuted 4 randomized blocks. Randomization is performed on the following website: www.sealedenvelope.com
Settings and conduct
This study is performed on premature newborns with a gestational age of 34 to 36 weeks that is hospitalized in the neonatal intensive care of Amir-al-Momenin Hospital in Semnan, Iran. The eligible premature newborns are randomly assigned to one of the two groups of local heat and control. First, in both groups, variables of pain intensity, body temperature, heart rate, and percentage of oxygen saturation are measured before the start of the study. Then, in the intervention group, in addition to routine measures, local heat is applied to the newborn's pubic area for 5 minutes. Routine measures are also performed in the control group. Then after 5 minutes, pain intensity, temperature, pulse, and percentage of oxygen saturation will be measured again. This is a single-blinded study.
Participants/Inclusion and exclusion criteria
Premature newborns between 34 to 36 weeks of gestational age
Inclusion criteria: APGAR score higher than 7; birth weight between 2200 to 2800 gr.
Exclusion criteria: Lack of consciousness of the newborn; Addiction in newborn's mother
Intervention groups
Groups of study:
1. Local heats
2. Control group
Main outcome variables
1. Pain severity due to urine bag removal
2. Body temperature
3. Heart rate
4. Spo2 saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101108005134N15
Registration date:2023-07-11, 1402/04/20
Registration timing:prospective
Last update:2023-07-11, 1402/04/20
Update count:0
Registration date
2023-07-11, 1402/04/20
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
2023-07-16, 1402/04/25
Expected recruitment end date
2024-02-14, 1402/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local heat on the pain severity due to urine bag removal in the preterm newborns
Public title
Effectiveness of local heat on newborns' pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
APGAR score higher than 7
Birth weight between 2200 to 2800 gr
Newborn's parent consent
Exclusion criteria:
Lack of consciousness of the baby
Congenital anomalies in newborn
Addiction of newborn's mother
Diabetics' mothers newborn
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the study, infants are divided into the intervention and control groups based on a 4-block randomized design. The randomization unit is individual. The number of newborns is equal in each group. There isn't stratified randomization and allocation concealment. Randomization is performed by following the website:
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
2023-05-22, 1402/03/01
Ethics committee reference number
IR.SEMUMS.REC.1402.028
Health conditions studied
1
Description of health condition studied
Premature newborn
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]
Primary outcomes
1
Description
Pain intensity
Timepoint
Beginning of the study, and 5 minutes after end of intervention
Method of measurement
Neonatal Infant Pain Scale
Secondary outcomes
1
Description
Heart rate
Timepoint
Beginning of the study, and 5 minutes after end of intervention
Method of measurement
Pulse oximeter
2
Description
O2 saturation percent
Timepoint
Beginning of the study, and 5 minutes after end of intervention
Method of measurement
Pulse oximeter
3
Description
Body temperature
Timepoint
Beginning of the study, and 5 minutes after end of intervention
Method of measurement
Digital temperature
Intervention groups
1
Description
Intervention group: Applying local heat using a heating pad with dimensions of 16 x 8 and a temperature of 34 to 37 degrees Celsius for 5 minutes on the pubic area. The heating pad has a cover so that the baby's skin is not damaged.
Category
Treatment - Other
2
Description
Control group: No special action is taken in this group and it serves as a witness for the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir -al- Momenin
Full name of responsible person
Dr. Sati Nik Darzi
Street address
Imam Hussein Square, in front of the 400 -unit apartment complex
City
Semnan
Province
Semnan
Postal code
3514734731
Phone
+98 23 3346 0066
Email
amir.hospital@semums.ac.ir
Web page address
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
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1021
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
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4192
Fax
+98 23 3365 4192
Email
alimovi49@sem-ums.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
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4192
Fax
+98 23 3365 4192
Email
alimovi@sem-ums.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
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4192
Fax
+98 23 3365 4192
Email
alimovi@sem-ums.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