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Mother Scented Simulated Hand for Mechanically Ventilated Preterm Neonates During Invasive Procedures? (Zaky-Hand)

Primary Purpose

Pain, Distress, Emotional

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mother-Scented Simulated Hand
NICU Standard Care
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Simulated Hand, Comfort, Pain, Distress, Invasive procedures, Preterm Neonates

Eligibility Criteria

1 Day - 28 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mother-Scented Simulated Hand

NICU Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2021
Last Updated
October 7, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05080582
Brief Title
Mother Scented Simulated Hand for Mechanically Ventilated Preterm Neonates During Invasive Procedures?
Acronym
Zaky-Hand
Official Title
Does Mother Scented Simulated Hand Promote Comfort, Reduce Pain and Distress Among Mechanically Ventilated Preterm Neonates During Invasive Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Distress, Emotional
Keywords
Simulated Hand, Comfort, Pain, Distress, Invasive procedures, Preterm Neonates

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mother-Scented Simulated Hand
Arm Type
Experimental
Arm Description
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.
Arm Title
NICU Standard Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mother-Scented Simulated Hand
Intervention Description
Preterm neonates wrapped with a warm Mother-Scented Simulated Hand during the invasive procedures
Intervention Type
Behavioral
Intervention Name(s)
NICU Standard Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of comfort, pain and distress
Description
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.
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman m Taha, professor
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
ZIP/Postal Code
56321
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26482579
Citation
Wu TW, Azhibekov T, Seri I. Transitional Hemodynamics in Preterm Neonates: Clinical Relevance. Pediatr Neonatol. 2016 Feb;57(1):7-18. doi: 10.1016/j.pedneo.2015.07.002. Epub 2015 Aug 29.
Results Reference
background
PubMed Identifier
21874145
Citation
Holsti L, Grunau RE, Shany E. Assessing pain in preterm infants in the neonatal intensive care unit: moving to a 'brain-oriented' approach. Pain Manag. 2011 Mar 1;1(2):171-179. doi: 10.2217/pmt.10.19.
Results Reference
background
PubMed Identifier
30414885
Citation
Loos HM, Reger D, Schaal B. The odour of human milk: Its chemical variability and detection by newborns. Physiol Behav. 2019 Feb 1;199:88-99. doi: 10.1016/j.physbeh.2018.11.008. Epub 2018 Nov 8.
Results Reference
background
PubMed Identifier
29275070
Citation
Pineda R, Bender J, Hall B, Shabosky L, Annecca A, Smith J. Parent participation in the neonatal intensive care unit: Predictors and relationships to neurobehavior and developmental outcomes. Early Hum Dev. 2018 Feb;117:32-38. doi: 10.1016/j.earlhumdev.2017.12.008. Epub 2017 Dec 21.
Results Reference
background
PubMed Identifier
30026767
Citation
Zeraati H, Nasimi F, Rezaeian A, Shahinfar J, Ghorban Zade M. Effect of Multi-sensory Stimulation on Neuromuscular Development of Premature Infants: A Randomized Clinical Trial. Iran J Child Neurol. 2018 Summer;12(3):32-39.
Results Reference
background
PubMed Identifier
30335622
Citation
Vittner D, Butler S, Smith K, Makris N, Brownell E, Samra H, McGrath J. Parent Engagement Correlates With Parent and Preterm Infant Oxytocin Release During Skin-to-Skin Contact. Adv Neonatal Care. 2019 Feb;19(1):73-79. doi: 10.1097/ANC.0000000000000558.
Results Reference
background
PubMed Identifier
19692803
Citation
van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
Results Reference
background

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

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