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Recruiting NCT06415240

Effect of Facilitated Tucking and Gentle Human Touch on Procedural Pain Among Neonates

No phase Interventional Non Pharmacological Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Facilitated Tucking, Gentle Human Touch.
Who it may be relevant to
Registry conditions: Non Pharmacological Pain Management. Basic parameters: 1 Day — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit

Overview

This is a Randomized Control Trial intended to investigate the effect of two non-pharmacological interventions on procedural pain among neonates.

Detailed description

The Study Design is a Randomized Control Trial, intended to investigate the effect of facilitated tucking and gentle human touch on procedural pain among neonates (age 28 days). Neonatal Infant Pain Scale will be used for pain scoring, data will be collected by recording demographic variables for all neonates and then capturing a video recording for pain scoring by an independent research assistant.

Interventions

  • Other Facilitated Tucking
    Facilitated Tucking is a position to be adopted for pain relief in neonates.
  • Other Gentle Human Touch
    while gentle human touch is caressing on head for pain relief.

Primary outcome measures

  • Neonatal Infant Pain Scale [Time frame: Before,During Arterial Prick and after three minutes]

Eligibility criteria

Inclusion criteria

  • Both term and preterm neonates.
  • APGAR scores of a minimum of 6 at one minute and 8 at 5 minutes
  • Admitted to the Neonatal Intensive Care Unit
  • Undergoing arterial prick for the first time.

Exclusion criteria

  • Documented birth asphyxia
  • Congenital anomalies
  • Neurological diagnosis,
  • ventilated with paralysis
  • Extremely premature newborns (Gestational age < 28 weeks)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 2 centers
  • Pakistan Institute of Medical Sciences — Islamabad
  • Shifa Tameer E Millat University — Islamabad

Identifiers

NCT: NCT06415240 · STMU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗