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The effect of positioning with an octopus doll on the behavioral responses of premature infants under non-invasive ventilation

Protocol summary

Study aim
Determining the effect of positioning with an octopus doll on the behavioral responses of preterm infants under non-invasive ventilation
Design
Clinical trial with control group, crossover, double-blind, randomized using envelope method and with a sample size of 25.The study is a cross-sectional design and 25 infants under study are also in their control group.
Settings and conduct
Twenty-five preterm infants between the ages of 28 and 34 weeks will be admitted to the NICU of Ommolbanin Hospital under non-invasive ventilation who meet the inclusion criteria. Behavioral reactions are recorded during the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: parental consent, infant 28 to 34 weeks, maximum 24 hours after the start of non-invasive ventilation, No invasive procedure was performed on the infant 2 hours before admission to the study, no contraindications to change position, no drug use in the mother during pregnancy and after Delivery, not using drugs that affect the sleep-wake cycle of the baby, not prescribing sedatives, having a 5 minute Apgar score higher than 6, not having surgery on the baby after birth.exclusion criteria: Congenital and chromosomal abnormalities, asphyxia, intracerebral hemorrhage more than first grade, sepsis, heart disease, metabolic, anemia. SGA and IUGR.
Intervention groups
To perform the intervention, in the supine position, the octopus doll will be placed in the baby's arms and the doll's feet will be in contact with the baby's body and hands. The babies of the first group will be placed in the fetal position for the first 2 hours. In the second 2 hours, they will be placed in the fetal position with the touch of an octopus doll, and in the babies of the second group, the opposite will be done. The neonates under study are also used as their control group.
Main outcome variables
Behavioral responses

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201007048967N1
Registration date: 2020-12-20, 1399/09/30
Registration timing: registered_while_recruiting

Last update: 2020-12-20, 1399/09/30
Update count: 0
Registration date
2020-12-20, 1399/09/30
Registrant information
Name
Kimia Razi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
razik961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-23, 1399/08/02
Expected recruitment end date
2021-04-22, 1400/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of positioning with an octopus doll on the behavioral responses of premature infants under non-invasive ventilation
Public title
The effect of positioning with an octopus doll on the behavioral responses of premature infants under non-invasive ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Guardian parent's consent for the infant to participate in the study infant age in the range of 28 to 34 weeks (based on LMP or sonography of the first trimester of pregnancy) under non-invasive ventilation maximum 24 hours after the start of non-invasive ventilation No invasive procedure was performed on the infant 2 hours before admission to the study no contraindications to change position no drug use in the mother during pregnancy and postpartum no use of drugs that affect the sleep and wake cycle of the baby such as theophylline, phenobarbital lack Prescribing sedatives such as midazolam and fentanyl Having an Apgar score of 5 minutes above 6 no surgery on the infant after birth
Exclusion criteria:
Congenital and chromosomal abnormalities asphyxia intracerebral hemorrhage more than first grade sepsis heart disease metabolic disease anemia SGA and IUGR
Age
From 7 months old to 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly assigned to two groups using the envelope method. This is how the envelopes will be prepared and printed by one of the members of the research team and random numbers with the help of Randomaize.com site and will be placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is first explained to the infant's parents, and if they wish, they sign the informed consent form and take an envelope, and then open it, and based on the contents of the envelope, the infant enters the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the subjects under study who are premature infants are not aware of the study and also the analyst will be unaware of the intervention and control groups.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research School of Nursing and Midwifery - Mashhad University of Medical Science
Street address
School of Nursing and Midwifery., Ibn Sina St, Ph.D. Intersection., Daneshgah St, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-08-03, 1399/05/13
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.038

Health conditions studied

1

Description of health condition studied
behavioral responses of premature infants
ICD-10 code
P07.3
ICD-10 code description
preterm infants

Primary outcomes

1

Description
behavioral response of premature infants (sleep, wakefulness and restlessness)
Timepoint
Behavioral reactions of premature infants will be observed 2 minutes before the intervention, 2 minutes during and 2 minutes after the intervention and in each turn will be observed for 30 seconds and will be recorded in the relevant form.
Method of measurement
In this study, the infant's behavioral response is assessed using the Anderson Behavioral Reaction Scoring System (ABSS), which measures the infant's behavior with sleep, wakefulness, and restlessness. This scoring system determines a baby's behavioral status based on observation of respiratory order, open or closed eyes, trunk and limb activity, and crying intensity. The scoring system consists of 12 levels and behavioral states are classified into three categories: sleep, wakefulness, and restlessness. The scores are 1-5 related to sleep, 6-8 points related to wakefulness and rest, and 9-12 points related to restlessness. Based on this ABSS tool, 2 minutes before, 2 minutes during and 2 minutes after the intervention and at each turn for 30 seconds, the reactions of the baby's behaviors will be observed and recorded in the relevant form. In the Anderson Behavior Scoring System, the infant is observed for 30 seconds and the number corresponding to the highest behavioral state observed is recorded with one exception: Conscious Inactivity, which is a desirable but relatively rare state when it occurs. It is possible even if another state with the highest number occurs in the same 30 seconds, because conscious inactivity is a desirable state in infants

Secondary outcomes

1

Description
Timepoint
Method of measurement

2

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group: The infants of the first group will be placed in the fetal position for the first 2 hours and then in the second 2 hours they will be placed in the fetal position with the touch of an octopus doll. In this study, the octopus doll is placed in the baby's arms and the doll's feet are placed in contact with the baby's body and hands. And the interventions will be repeated for 3 consecutive days in a fixed evening shift.
Category
N/A

2

Description
Control group: In the infants of the second group, they will be in contact with the doll in the first 2 hours and the doll will be removed from the baby in the second 2 hours. For the wash out phase, the babies will be in a supine position for 2 hours.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ommolbanin hospital
Full name of responsible person
Hamidreza Behnam Vashani
Street address
Corner of Ayatollah Behjat 16, Zarrineh Crossroads, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9171618995
Phone
+98 51 3223 1061
Email
behnamhr@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Rabab Latifnejad Rudsari
Street address
School of Nursing and Midwifery., Ibn Sina St, Ph.D. Intersection., Daneshgah St, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
latifnejadr@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
Kimia Razi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Ibn Sina St, Ph.D. Intersection., Daneshgah St, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
razik961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
kimia Razi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Ibn Sina St, Ph.D. Intersection., Daneshgah St, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
razik961@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
kimia razi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Ibn Sina St, Ph.D. Intersection., Daneshgah St, Mashhad, Khorasan Razavi.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
38591511 051
Email
razik961@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after unidentified individuals.
When the data will become available and for how long
The start of the access period is 2 months after the results are published.
To whom data/document is available
The data will be made available to researchers working in academic and scientific institutions and to people in the relevant industry and to the relevant ministry.
Under which criteria data/document could be used
If this study has a positive effect, the effect of touching an octopus doll on the behavioral response of a premature infant under non-invasive ventilation can be used as a useful and acceptable solution to reduce stress and help calm the infant in the neonatal intensive care unit. As a result, increased relaxation is the most important element in the development of the premature nervous system.
From where data/document is obtainable
Kimia Razi: razik961@mums.ac.ir Phone: 09156516202 Hamidreza Behnam Vashani: behnamhr@mums.ac.ir Phone: 09151109514
What processes are involved for a request to access data/document
The applicant must communicate via the contact number and e-mail address provided.
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