Determining the effect of the four-handed method on the pain caused by gastric tube insertion in premature infants admitted to the neonatal intensive care unit.
Design
A clinical trial with control group, with parallel groups, single-blind, randomized, will be conducted on 80 premature babies.
Settings and conduct
The researcher will measure the pain level of premature babies during oral-gastric tube insertion using PIPP tool in two control and intervention groups. In the control group, oral-gastric tube insertion will be done by the routine method of the department, in the intervention group, the oral-gastric tube will be inserted using the four-hand method, and then the pain level will be compared in the two groups. The environment of this research is the NICU of Valiasr Hospital and Shariati Hospital.
Participants/Inclusion and exclusion criteria
Age at birth less than 37 weeks; lack of congenital abnormalities or genetic disorders; not having mechanical ventilation; not receiving drugs affecting the physiological and behavioral state such as anticonvulsants, sedatives, and narcotics at least in the last 24 hours; not having the painful procedure is at least half an hour before the intervention and there is no history of drug use by the mother.
Intervention groups
In the control group, oral-gastric tube placement will be done by the routine method, i.e. two-handed method, by one person, and the researcher will not do any intervention, and in the intervention group, oral-gastric tube placement will be done by the four-handed method.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220921056009N1
Registration date:2022-10-16, 1401/07/24
Registration timing:prospective
Last update:2022-10-16, 1401/07/24
Update count:0
Registration date
2022-10-16, 1401/07/24
Registrant information
Name
Maryam Shirdel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2248 5708
Email address
marish161072@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of four-handed method on the pain due to gastric tube insertion in premature infants in Neonatal Intensive Care Unit
Public title
Investigation of the effect of four-handed method on the pain due to gastric tube insertion in premature infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All infants admitted to the NICU who are less than 37 weeks of age at birth.
Exclusion criteria:
Having a congenital abnormality or genetic disorder
Receiving drugs affecting the physiological and behavioral state in the last 24 hours
Having a painful procedure up to half an hour before the intervention
History of drug use by mother
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Infants will be placed in two control and intervention groups in a simple random fashion by tossing a coin.
One of the groups is head and the other is tail. A coin is tossed according to the sample size and people are randomly assigned to two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that the participants in the research are infants, so they do not know about the study, so the study is considered a blind strain.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Ethics Faculty of Nursing and Midwifery TUMS
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat East St., Toheed Square, Tehran
City
Tehran
Province
Tehran
Postal code
Ethics@sina.tums.ac.
Approval date
2022-08-17, 1401/05/26
Ethics committee reference number
IR.TUMS.FNM.REC.1401.068
Health conditions studied
1
Description of health condition studied
Premature infants
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services
Before, during and 30 seconds after the intervention
Method of measurement
PIPP tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: oral-gastric tube insertion will be done by four-handed method and then the pain level will be compared in two groups. In four-handed care, in addition to the nurse inserting the gastric tube, another person also helps in this process, and this person actually provides supportive care for the baby and supports the baby's head and limbs with his two hands. When the baby is restless, he supports and maintains the baby's position by gently and gently touching the baby, and during the process of inserting the gastric tube, he can help the nurse inserting the gastric tube to improve its efficiency.
Category
Prevention
2
Description
Control group: In the control group, oral-gastric tube placement will be done by the routine method of the department, i.e. two-handed method, by one person, and the researcher will not do any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital and Imam Khomeini Hospital
Full name of responsible person
Batul Puraboli
Street address
Tehran University, Faculty of Nursing and Midwifery, Dr. Mir Khani St., Toheed Square (East Nusrat), Tehran.
City
Tehran
Province
Tehran
Postal code
b-pouraboli@ sina.tu
Phone
+98 913 397 8059
Email
b-pouraboli@ sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Geranmayeh
Street address
Tehran University of Medical Sciences Headquarters, Qods Corner, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
tumspr@tums.ac.ir
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Shirdel
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran University, Faculty of Nursing and Midwifery, Mirkhani St., Nosrat East St., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
0098 66421685
Email
marish161072@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batul Puraboli
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Dr. Mir Khani St., Toheed Square (East Nusrat), Tehran
City
Tehran
Province
Tehran
Postal code
b-pouraboli@ sina.tu
Phone
+98 21 6105 4411
Email
b-pouraboli@ sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Shirdel
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran University of Medical Sciences, School of Nursing and Midwifery, Mirkhani St., Nosrat East St., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 1685
Email
marish161072@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
In the form of theses and articles
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Only with the permission of the supervisor and University of Tehran
From where data/document is obtainable
Supervisor
What processes are involved for a request to access data/document