1. Home
  2. Approved trials
  3. » فارسی

The effect of the nurse's compassionate speech on the pain and stress of intravenous catheter insertion in premature neonates

Protocol summary

Study aim
Determining the effect of the nurse's compassionate speach on the pain and stress of premature neonats caused by intravenous catheter insertion
Design
A clinical trial with a control group, with single blinded and non randomized parallel groups on 60 premature neonate.
Settings and conduct
Neonatal intensive care unite of Ghaem and Imam Reza Mashhad hospitals. with blinding of outcome assessors and data analysts.
Participants/Inclusion and exclusion criteria
Entry requirements for infants: A premature neonates with a gestational age of 28 to 34 weeks , A neonate's weighing at least 1 kg , At least one hour has passed since feeding the neonates , Parents' consent to participate in the research , The neonate should be calm and alert , The neonate should be healthy in terms of hearing with the OEA test. Entry requirements for nurses: Willingness to cooperate in this research , At least 3 years of work experience in the neonatal intensive care unit. Conditions for non-entry of infants: A neonate with a history of surgery , A neonate with an Apgar score of 5 minutes below 6 , neonates with major congenital malformations , neonates requiring CPAP or connected to a tracheal tube , A neonate with an addicte mother , A neonate with a history of taking painkillers and sleeping pills in the last 24 hours. Conditions for non-entry of nurses: Violence and tightness of the vocal cords
Intervention groups
In the intervention group, in case of need for venipuncture, in addition to performing routine pain-reducing interventions such as using non-nutritive sucking and a nest, the nurse will talk compassionately with the neonate. In the control group, in case of need for venipuncture routine pain-reducing measures such as using non-nutritive sucking and nests will be performed.
Main outcome variables
Neonatal pain , Neonatal stress , The success rate of nurses in venipuncture.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230529058335N1
Registration date: 2023-07-19, 1402/04/28
Registration timing: prospective

Last update: 2023-07-19, 1402/04/28
Update count: 0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Reyhaneh Omidvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 1658
Email address
omidvarr4012@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the nurse's compassionate speech on the pain and stress of intravenous catheter insertion in premature neonates
Public title
The effect of the nurse's speech on the pain and stress of neonates
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Entry requirements for neonates : Neonats weighing more than 1 kg Premature neonats with a gestational age of 28 to 34 weeks Since feeding the neonate at least one hour has passed The neonat should be calm and alert The neonats 's hearing is healthy with the OAE test The parents of the neonat must consent to participate in the research Entry requirements for nurses : Willingness to cooperate in this research At least 3 years of work experience in the neonatal intensive care unit
Exclusion criteria:
Conditions for non-entry of neonates : The Apgar score of the fifth minute of the neonat should be less than 6 have a major congenital anomaly The neonat need CPAP or connected to a tracheal tube have a history of taking analgesic and sedative medicine in the past 24 hours The neonat's mother should be addict Have a history of surgery Conditions for non-entry of nurses : Violence and tightness of the vocal cords
Age
From 112 days old to 136 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors, analysts are blinded. The evaluator, who is made up of professors and experts, only performs the grading by watching the movie without sound, and the data analyzer analyzes only through the given numbers from the scales. it is necessary to mention each neonat's form has a code for the control and intervention group, and only I, who record the procedure, know the classification of the codes.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
University Street, Central Building of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2023-06-24, 1402/04/03
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.046

Health conditions studied

1

Description of health condition studied
The study is about the pain and stress of premature neonats during intravenous catheter insersion.
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
The amount of pain in neonates of the intervention and control groups will be evaluated.
Timepoint
1 minute before the start of the intervention, the first 30 seconds of the start of the intervention, 1 and 5 minutes after the end of the intervention
Method of measurement
Registering ،the amount of pain in neonates using the (PIPP) premature infant pain profile

2

Description
The amount of stress in neonates of the intervention and control groups will be evaluated.
Timepoint
1 minute before the start of the intervention, the first 30 seconds of the start of the intervention, 1 and 5 minutes after the end of the intervention
Method of measurement
Registering the amount of stress in neonates using the (NISS) newborn infant stress scale

Secondary outcomes

1

Description
Success rate in venous catheter placement
Timepoint
After each intervention
Method of measurement
The number of unsuccessful attempts to insert a venous catheter

Intervention groups

1

Description
Intervention group: 6 nurses who meet the entry criteria are trained in compassionate talking with neonate.And one day, during a shift, they talk to their neonate for at least 45 minutes alternately while taking care. From the second day onwards, whenever the neonate needs veinpuncture, in addition to the usual pain control measures, the nurse will have a compassionate conversation from 5 minutes before the procedure to the end of the procedure. Examinations are done 1 minute before the intervention and the nurse's speech, 30 seconds after the nurse's speech, 1 and 5 minutes after the procedure is finished. the neonate's stress level with the newborn infant stress scale (NISS) and the neonate 's pain level with the premature infant pain profile (PIPP) will be measured.
Category
Behavior

2

Description
Control group: For the control group, whenever veinpuncture is needed, the usual pain control measures such as non-nutritive sucking and nesting will be performed. And the examinations are done 1 minute before the start of the intervention, 30 seconds after the insertion of the catheter, 1 and 5 minutes after the procedure is finished. the neonate's stress level with the newborn infant stress scale (NISS) and the neonate's pain level with the premature infant pain profile (PIPP) will be measured.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Reyhaneh Omidvar
Street address
Ebne sina Street ,Imam reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91379113316
Phone
+98 51 3854 3031
Email
IRH.p.relations@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Reyhaneh Omidvar
Street address
Ahmad abad Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
b.ghaem@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour
Street address
Daneshgah Street, Central building of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Reyhaneh Omidvar
Position
Master Of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Doctora Junction, Eibn-sina st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
omidvarR4012@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naghmeh Razaghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051338591511
Email
RazaghiN@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reyhaneh Omidvar
Position
Master Of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Doctora Junction, Eibn-sina st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
omidvarR4012@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
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
At the end of the work and after printing the article, with permission from the Mashhad Nursing and Midwifery Faculty and the relevant professors, the information will be accessible in the central library of the Mashhad Nursing and Midwifery Faculty in the student thesis.
When the data will become available and for how long
Access starts 2 months after results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Researchers with related fields can use the data and results by mentioning the reference.
From where data/document is obtainable
Correspondence with project manager Dr. Naghme Razaghi RazaghiN@mums.ac.ir Postal code: 91778-99191
What processes are involved for a request to access data/document
Apply by email
Comments
Loading...