Clinical trial NCT05080582: Mother Scented Simulated Hand for Mechanically Ventilated Preterm Neonates During Invasive Procedures?
Official title: Does Mother Scented Simulated Hand Promote Comfort, Reduce Pain and Distress Among Mechanically Ventilated Preterm Neonates During Invasive Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Distress, Emotional
Keywords: Simulated Hand
Comfort
Pain
Distress
Invasive procedures
Preterm Neonates
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 62
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Preterm
* Newly admitted
* Hemodynamic stability

Exclusion Criteria:

* Receiving sedatives
* Low APGAR score lower than three at five minutes
* Hypothermia
* Hypoglycemia
* Hyperglycemia
* Intraventricular hemorrhage grade III\& IV
* Neonatal seizures

Primary outcomes:
measure: Level of comfort, pain and distress
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
affiliation: Alexandria University
name: Eman m Taha, professor
role: STUDY_CHAIR
References:
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