Comparison of the effect of touch by mother and nurse on the intensity of pain and physiological responses caused by venipuncture
Design
A clinical trial with control and parallel groups, without blinding, randomized, phase 2 on 60 patients. The following website is used for randomization:
www.sealedenvelope.com
Settings and conduct
The study field is the neonatal ward of the Velayat Hospital in Damghan, Semnan, Iran; The studied population is infants in the age range from birth to 28 days; Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age from birth to 28 days; newborn's parent consent; Maturity of newborn. Exclusion criteria: Lack of consciousness of the newborn; High risk newborns; Addiction in newborn's mother
Intervention groups
Intervention group 1: nurse's touching on the venipuncture site; Intervention group 2: mother's touching on the venipuncture site; Control group: the routine practices
Main outcome variables
Intensity of pain; Respiration rate; Heart rate; Oxygen saturation percent
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101108005134N16
Registration date:2024-07-25, 1403/05/04
Registration timing:prospective
Last update:2024-07-25, 1403/05/04
Update count:0
Registration date
2024-07-25, 1403/05/04
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
recruiting
Funding source
Expected recruitment start date
2024-08-20, 1403/05/30
Expected recruitment end date
2025-08-21, 1404/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of mothers’ and nurses’ touch effect on the severity of pain and physiological responses of neonates during venipuncture
Public title
The effect of nurse's touch on the reducing of pain due to venipuncture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age from birth to 28 days
Complete gestational age of newborn (being term)
Newborn's parent consent
Exclusion criteria:
Lack of consciousness of the newborn
High risk newborns
Addiction of newborn's mother
Diabetic mother's newborn
Age
From 1 day old to 30 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible newborns are assigned to the intervention and control groups by randomized block design using blocks of size 4. Randomization is done by the website www.sealedenvelope.com. At first the interventions and control groups will be defined. Then the block size is considered 4 with the list length of 60. Also, the randomization unit is individual and the number of newborns in each of the two groups is equal. There is also no stratification and allocation concealment.
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
Vice chancellor for research and Technology, Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2024-06-10, 1403/03/21
Ethics committee reference number
IR.SEMUMS.REC.1403.030
Health conditions studied
1
Description of health condition studied
Venipuncture related pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity
Timepoint
Beginning of the study, during and 3 minutes after end of intervention
Method of measurement
Neonatal Infant Pain Scale
2
Description
Heart rate
Timepoint
Beginning of the study, during and 3 minutes after end of intervention
Method of measurement
Pulse oximeter
3
Description
Respiration rate
Timepoint
Beginning of the study, during and 3 minutes after end of intervention
Method of measurement
Clinical assessment (counting respiration number in one minute)
4
Description
Oxygen saturation percent
Timepoint
Beginning of the study, during and 3 minutes after end of intervention
Method of measurement
Pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Touching the venipuncture location by nurse's hand for one minute
Category
Treatment - Other
2
Description
Intervention group 2: Touching the venipuncture location by mother's hand for one minute
Category
Treatment - Other
3
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
Damghan's Velyat hospital
Full name of responsible person
Dr. Faeze Zarezadeh
Street address
After Islamic Azad University, Cheshmeh Ali Bvld
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5120
Email
velayathos@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid Mirmohammadkhani
Street address
Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@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
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
009833654192
Email
Alimovi49@semums.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
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@semums.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
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Paramedicine, Semnan University of Medical Sciences, 5th Kilometer of Damghan road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4192
Fax
+98 23 3365 4192
Email
Alimovi49@semums.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