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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201007048967N1
Enrollment
25
Registered
2020-12-20
Start date
2020-10-23
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

behavioral responses of premature infants. preterm infants

Interventions

Intervention 1: 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 w

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Months to 8 Months

Inclusion 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

Exclusion criteria: Congenital and chromosomal abnormalities asphyxia intracerebral hemorrhage more than first grade sepsis heart disease metabolic disease anemia SGA and IUGR

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
. Timepoint: . Method of measurement: .;. Timepoint: . Method of measurement: .

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKimia Razi

Mashhad University of Medical Sciences

razik961@mums.ac.ir+98 51 3859 1511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026