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The effect of environmental and behavioral interventions on physiological and behavioral responses of preterm infants candidate for intravenous catheterization in neonatal intensive care units

Protocol summary

Summary
41 preterm infants whose parents agreed with their participation in the present study, were selected. The infants were randomly assigned into two experimental and control groups. In the experimental group, demographic, basic and physiological information questionnaire was completed with NIPS & EDIN Scale before implementing any intervention. Then, environmental and behavioral interventions such as closing the infants’ eyes to reduce the light using eye pad, closing the infants’ ears to reduce auditory simulations using ear plugs and placing the baby in an embryonic state to reduce environmental simulations using the nests prepared by the researcher, were implemented by researcher. 30 minutes after intervention, while the intervention was going on, intravenous catheter placement was performed by a qualified nurse. At the same time, a graduate student who knew how to fill the measuring tools and had at least one year working experience in the neonatal ward, filled the related checklist at the times of 2 minutes before, during and 5 minutes after intravenous catheter placement. Then, 30 minutes after intravenous catheter placement, while the intervention was going on, the physiologic information form and related checklists were filled again and the infant was removed from the study after an hour. No environmental and behavioral interventions were implemented on the infants in the control group, but, like the first time, all the stages of collecting information and filling the checklists were performed and recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011231892N1
Registration date: 2017-09-24, 1396/07/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-24, 1396/07/02
Registrant information
Name
Anahita Masoumpoor
Name of organization / entity
Martyr Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
masoumpoor.a@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Researcher
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of environmental and behavioral interventions on physiological and behavioral responses of preterm infants candidate for intravenous catheterization in neonatal intensive care units
Public title
The effect of environmental and behavioral interventions on physiological and behavioral responses of preterm infants candidate for intravenous catheterization in neonatal intensive care units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria; gestational age of 30-37 weeks;admission to neonatal intensive care unit; requiring administration of intravenous fluids and catheter; constant positive airways pressure (N-CPAP); no use of sedatives، anticonvulsants، or anesthetics; no comorbidities such as congenital abnormalities, neurological problems, or cerebral intra-ventricular hemorrhage and seizures and;fully conscious infant; Exclusion criteria; parents withdrawing participation of their infant; failure to insert intravenous catheter in two attempts; critical illness of infant in the process of its disease interfering with interventions; lack of response to N-CPAP .
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using colored beads

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Martyr Beheshti University of Medical Sciences
Street address
Tehran, Vali Asr intersection of prayer, the Heart Hospital Rajai martyr, martyr Beheshti University of Medical Sciences
City
Tehran
Postal code
1985717443
Approval date
2016-11-13, 1395/08/23
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.587

Health conditions studied

1

Description of health condition studied
Premature infants
ICD-10 code
p07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.

Primary outcomes

1

Description
physiological responses
Timepoint
2 minutes before venipuncture, during venipuncture, 5 and 30 minutes after venipuncture
Method of measurement
Pulse monitoring, observation

Secondary outcomes

1

Description
Behavioral responses
Timepoint
2 minutes before venipuncture, during catheter insertion, 5 and 30 minutes after venipuncture
Method of measurement
NIPS scale & EDIN scale

Intervention groups

1

Description
The intervention implemented in the experimental group: “environmental and behavioral interventions such as closing the infants’ eyes to reduce the light using eye pad, closing the infants’ ears to reduce auditory simulations using ear plugs and placing the baby in an embryonic state to reduce environmental simulations using the nests prepared by the researcher, are implemented by researcher. 30 minutes after intervention, while the intervention is going on, intravenous catheter placement is performed by a qualified nurse. At the same time, a nurse who knows how to fill out the measuring tools and has at least one year working experience in the neonatal ward, fills out the related checklist at the time of 2 minutes before, during and 5 minutes after intravenous catheter placement. Then, 30 minutes after intravenous catheter placement, while the intervention is going on, the physiologic information form and related checklists are filled out again and the infant is removed from the study after an hour.”
Category
Behavior

2

Description
The intervention implemented in the control group: “no environmental and behavioral interventions, except for routine cares, are implemented on the infants in the control group, but all the stages of collecting information and filling out the checklists are done and recorded like the first time.”
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Al zahra Isfahan
Full name of responsible person
Shohreh Taheri Karchegani , Nursing Graduate Student newborns
Street address
Hospital Alzahra, Sofe Blvd, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Martyr Beheshti University of Medical Sciences
Full name of responsible person
Shohreh Taheri Karchegani
Street address
School of Nursing and Midwifer, The intersection of prayer, Valiasr Street, The martyr Rajai Hospital Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Martyr Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Martyr Beheshti University of Medical Sciences
Full name of responsible person
Shohreh Taheri Karchegani
Position
Master's student nursing specialist neonates
Other areas of specialty/work
Street address
School of Nursing and Midwifer, The intersection of prayer, Valiasr Street, The martyr Rajai Hospital Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 218822521
Email
sbnmf@sbmu.ac.ir
Web page address
sbnmf@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Martyr Beheshti University of Medical Sciences
Full name of responsible person
Anahita Masoumpoor
Position
Phd
Other areas of specialty/work
Street address
School of Nursing and Midwifer, The intersection of prayer, Valiasr Street, The martyr Rajai Hospital Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 218822421
Email
anahitakasra@yahoo.co.in
Web page address
www.sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Martyr Beheshti University of Medical Sciences
Full name of responsible person
Anahita Masoumpoor
Position
Phd
Other areas of specialty/work
Street address
School of Nursing and Midwifer, The intersection of prayer, Valiasr Street, The martyr Rajai Hospital Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 218822521
Email
anahitakasra@yahoo.co.in
Web page address
www.sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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