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Completed

NCT Number: NCT05080582

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

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

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Key information

Conditions

Pain Distress, Emotional Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing

Alexandria, 56321, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mother-Scented Simulated Hand

Behavioral

Preterm neonates wrapped with a warm Mother-Scented Simulated Hand during the invasive procedures

NICU Standard Care

Behavioral

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 outcomes

  1. Level of comfort, pain and distress

    Time frame: immediately after the intervention

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: Zaky-Hand

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2021
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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