Determining the effect of nesting and positioning on the amount of pain and physiologic measurements of surgical term neonates.
Design
In this study, 75 neonates who undergo surgery and have the inclusion criteria are randomly divided into two groups: intervention and control group
Settings and conduct
.This study is conducted in Sheikh Hospital on postoperative neonates in order to assess the effect of the nest and lateral position on pain score
Participants/Inclusion and exclusion criteria
Inclusion criteria:37-week-old fetal, severe cardiac and vascular disorders ,Surgery without restraint,
Exclusion criteria: newborn of addicted mother,
Intervention groups
Intervention group: After the admission of the newborn in the nest, the neonate is placed in the lateral position. After the intervention, physiological parameters and pain score are measured. The interval of measurement is 15 min and 30 min after the intervention. Then, the measurement of physiological parameters and pain score are done every 6 hours for up to 24 h. There is no intervention in the control group.
Main outcome variables
The pain is measured by physiological indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161219031469N2
Registration date:2018-03-12, 1396/12/21
Registration timing:retrospective
Last update:2018-03-12, 1396/12/21
Update count:0
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
Elahe momenie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 4785
Email address
momenie2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Mashhad University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Nesting and Posture on Pain and Physiological Criteria in Post-operative Term Neonates
Public title
The effect of nesting on neonates pain control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining informed consent from parents in order to participate in the intervention
pregnant women with gestational age of 37 weeks
Apgar Score 7 and higher
The absence of severe cardiac and vascular disorders
Surgeries without mobility limitation (Hirschsprung, Imperforated Anus, Types of atresia, Malrotion, Pyloric stenosis, Gastric atresia)
Exclusion criteria:
Parental dissatisfaction to participate in the intervention
newborn death
Addicted mother
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
75 admitted infants enter the study. the study population are divided to three groups. Samples are selected by simple random sampling method. In this way, by making a draw, the first group is identified.
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
Faculty of Nursing andMidwifery
Street address
Mashhad facutlty of Nursing and Midwifery;ibn-e sina st;Doktora crossing
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2017-02-06, 1395/11/18
Ethics committee reference number
ir.mums.rec.1395.512
2
Ethics committee
Name of ethics committee
Faculty of Nursing andMidwifery
Street address
Mashhad facutlty of Nursing and Midwifery;ibn-e sina st;Doktora crossing
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
ir.mums.rec.1395.512
Health conditions studied
1
Description of health condition studied
pain of surgery
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Physiological parameters
Timepoint
At the start of intervention, then up to 24 hours
Method of measurement
Measurement of physiological parameters
2
Description
pain
Timepoint
After the intervention,
Method of measurement
Pain assessment scale nips, cries
Secondary outcomes
1
Description
Oxygen saturation
Timepoint
After intervation
Method of measurement
Monitoring
2
Description
Respiratory
Timepoint
After intervation
Method of measurement
Monitoring
3
Description
Blood pressure
Timepoint
After intervation
Method of measurement
Measuring blood pressure
4
Description
Heart rate
Timepoint
Starting the intervention and up to 24 hours
Method of measurement
Monitoring
Intervention groups
1
Description
First group: First intervention group: The newborn is placed in the nest after the admission. The physiological criteria are measured 8 times for 24 hours.
Category
Prevention
2
Description
The second experimental group: Second intervention group: The newborn is placed in lateral position after admission.
Category
Prevention
3
Description
Control group: There is no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikh hospital
Full name of responsible person
Elaheh Momenie
Street address
Mashhad Faculty of nursing and Midwifery,Ibn-e Sina St;Doktora Crossing
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3859 1511
Email
Momenie2@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
University of Medical Sciences
Street address
Street University Building Qureshi
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3859 1511
Email
momenie2@mums.ac.ir
Grant name
Grant code / Reference number
950875
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
Momenie elahe
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3846 4785
Fax
Email
Momenie2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
DR.T.Sadeghy
Position
Phd in pediatrics
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mashhad School of Nursing and Midwifery Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3859 1511
Fax
Email
Momenie2@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Momenie Elahe
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad faculty of nursing and midwifery,ebn-sinaSt;Doktora crossing
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3846 4785
Fax
Email
Momenie2@mums.ac.ir
Web page address
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
Clinical Study Report
Yes - There is 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
Some of the data can be shared
When the data will become available and for how long
Get started six months after printing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Data access is allowed
From where data/document is obtainable
momenie-09155025202
What processes are involved for a request to access data/document