Mother Scented Simulated Hand for Mechanically Ventilated Preterm Neonates During Invasive Procedures?
NCT ID: NCT05080582
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2021-03-24
2021-06-30
Brief Summary
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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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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Mother-Scented Simulated Hand
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.
Mother-Scented Simulated Hand
Preterm neonates wrapped with a warm Mother-Scented Simulated Hand during the invasive procedures
NICU Standard Care
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.
NICU Standard Care
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.
Interventions
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Mother-Scented Simulated Hand
Preterm neonates wrapped with a warm Mother-Scented Simulated Hand during the invasive procedures
NICU Standard Care
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.
Eligibility Criteria
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Inclusion Criteria
* Newly admitted
* Hemodynamic stability
Exclusion Criteria
* Low APGAR score lower than three at five minutes
* Hypothermia
* Hypoglycemia
* Hyperglycemia
* Intraventricular hemorrhage grade III\& IV
* Neonatal seizures
1 Day
28 Days
ALL
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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Zohour Ibrahim Mahmoud Rashwan
Pediatric nurse specialist, Faculty of Nursing, principal Investigator, lecturer
Principal Investigators
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Eman m Taha, professor
Role: STUDY_CHAIR
Alexandria University
Locations
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Faculty of Nursing
Alexandria, , Egypt
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1614032021
Identifier Type: -
Identifier Source: org_study_id