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

Pain Clinical Trial

— Zaky-Hand  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05080582
• Other study ID #: 1614032021
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 30, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Distress, Emotional
• Pain
• Premature Birth

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Nursing	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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