Clinical Trials Directory

Trials / Completed

CompletedNCT05080582

Mother Scented Simulated Hand for Mechanically Ventilated Preterm Neonates During Invasive Procedures?

Does Mother Scented Simulated Hand Promote Comfort, Reduce Pain and Distress Among Mechanically Ventilated Preterm Neonates During Invasive Procedures

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
Alexandria University · Academic / Other
Sex
All
Age
1 Day – 28 Days
Healthy volunteers
Accepted

Summary

This study aimed to determine the effect of Mother-Scented Simulated Hand (MSSH) on promoting comfort among mechanically ventilated preterm neonates during invasive procedures. Research Hypotheses * Preterm neonates who receive MSSHH exhibit higher levels of comfort during invasive procedures than those who receive standard care. * Preterm neonates who receive MSSHH exhibit lower levels of pain and stress during invasive procedures than those who receive standard care

Detailed description

A quasi-experimental, pre-posttest, two group, study was carried out in NICU of in Smouha, Alexandria. A sample of 62 mechanically ventilated neonates were randomly assigned to two equal groups; the study group wrapped with a warm MSSH during the invasive procedures while the control group received standard care of NICU. Two observers independently rated the neonates' level of comfort, distress, and pain during Endotracheal Suctioning (ETS) and heel prick using COMFORTneo Scale. On day one of mechanical ventilation, the neonates received the same standard care of the NICU, while they wrapped with a warm Mother-Scented Simulated Hand as follow; simulated hand was scented with mothers' body odor by placing it on the mothers' bare chest or behind the neck for one hour. Then, the MSSH was placed under a radiant warmer for a couple of minutes to reach the mothers' unique warm touch. Inside the incubator, the mechanically ventilated neonates were placed in a side-lying flexed fetal position, where they encircled with the two warm simulated human hand to contain them. Where the palm of one MSSH cupped the neonates' head, and the palm of the other hand cupped the lower part of body and extremities. The neonates were kept in such a position throughout the mentioned invasive procedures. Neonates' physiological response, comfort, distress, and pain levels were assessed the same way as the first day.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMother-Scented Simulated HandPreterm neonates wrapped with a warm Mother-Scented Simulated Hand during the invasive procedures
BEHAVIORALNICU Standard CareNeonates were placed in a side-lying position, while their extremities were flexed close to the body and wrapped with rolled sheets or towels to simulate the intrauterine posture.

Timeline

Start date
2021-03-24
Primary completion
2021-06-22
Completion
2021-06-30
First posted
2021-10-18
Last updated
2021-10-18

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05080582. Inclusion in this directory is not an endorsement.