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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Distress, Emotional

Intervention / Treatment
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* Behavioral: Mother-Scented Simulated Hand
* Behavioral: NICU Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mother-Scented Simulated Hand<br>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, as shown in Figure 2. Neonates' physiological response, comfort, distress, and pain levels were assessed the same way as the first day. | Behavioral: Mother-Scented Simulated Hand<br>* Preterm neonates wrapped with a warm Mother-Scented Simulated Hand during the invasive procedures<br>|
| Active Comparator: NICU Standard Care<br>The neonates were provided with standard care, which entailed maintaining a quiet environment with minimal stimulation, uninterrupted periods of sleep, containment. Neonates 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. This position was maintained during the performance of the invasive procedures. | Behavioral: NICU Standard Care<br>* Neonates 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of comfort, pain and distress | COMFORTneo Scale: This scale was developed by Dijk et al. (2009). It is a numerical rating scale to assess neonates' comfort, distress and pain levels. It consists of 6 items, including alertness, calmness/agitation, respiratory response, body movement, facial tension, and muscle tone. The neonates' behavioral response was rated on 5 points numerical rating scale (1-5), and the total score ranged from 6 to 30. The lower score indicates a higher level of comfort and vice versa. The COMFORTneo scale has additional two Numerical Rating Scales (NRSs) for pain and distress. These scales are scored after the COMFORTneo score. Both of them range from zero to ten; the Zero score represents no pain or distress, while the ten score represents the worst imaginable pain or distress. | immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comfort, Pain, Distress, Simulated Hand, Invasive procedures, Preterm Neonates