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PainZaky-HandNCT05080582

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

A study testing Mother-Scented Simulated Hand in people with Pain and Distress, Emotional, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 1 day to 28 daysHealthy volunteers can take part
Conditions the study is for
Pain, Distress, Emotional
What is being tested?
Mother-Scented Simulated Hand
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteEgypt
Study dates
24 Mar 2021to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 28 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Preterm
  • Newly admitted
  • Hemodynamic stability

Who cannot join

  • Receiving sedatives
  • Low APGAR score lower than three at five minutes
  • Hypothermia
  • Hypoglycemia
  • Hyperglycemia
  • Intraventricular hemorrhage grade III\& IV
  • Neonatal seizures

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Nursing

    Alexandria, 56321

Other trials in Egypt

About this study

Official title: Does Mother Scented Simulated Hand Promote Comfort, Reduce Pain and Distress Among 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
Read the 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.

Being tested
Mother-Scented Simulated Hand, NICU Standard Care
Keywords
Simulated Hand, Comfort, Pain, Distress, Invasive procedures, Preterm Neonates
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mother-Scented Simulated HandBehavioural

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

  • NICU Standard CareBehavioural

    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.

Study groups in NCT05080582
Study groupRoleWhat they receive
Mother-Scented Simulated HandExperimentalThe 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.
Receives: Behavioral: Mother-Scented Simulated Hand
NICU Standard CareActive comparatorThe 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.
Receives: Behavioral: NICU Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study start24 Mar 2021
  3. Primary completion22 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05080582
Sponsor's protocol ID
1614032021
Acronym
Zaky-Hand
Status last verified
Oct 2021
First submitted
28 Sep 2021
Last updated
18 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26482579

  • 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.

    PubMed 21874145

  • 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.

    PubMed 30414885

  • 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.

    PubMed 29275070

  • 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.

    PubMed 30026767

  • 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.

    PubMed 30335622

  • 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.

    PubMed 19692803

Questions about this trial

What is this clinical trial studying?

A study testing Mother-Scented Simulated Hand in people with Pain and Distress, Emotional, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of comfort, pain and distress (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05080582, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.

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