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NCT Number: NCT06415240

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

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

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Key information

Conditions

Non Pharmacological Pain Management Neurologic Manifestations Pain Pain, Procedural 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

Pakistan Institute of Medical Sciences, Islamabad, Pakistan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Facilitated Tucking

Other

Facilitated Tucking is a position to be adopted for pain relief in neonates.

gentle human touch

Other

while gentle human touch is caressing on head for pain relief.

Primary outcomes

  1. Neonatal Infant Pain Scale

    Time frame: Before,During Arterial Prick and after three minutes

    scoring of pain based on a scale used in neonates both for term and pre term babies.( Minimum Pain Score 0, Maximum 7, Higher number indicates the worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Nazma Hamid, MSN

CONTACT

[email protected]

03421547629

Sponsors and collaborators

Lead sponsor

Shifa Tameer-e-Millat University

Other

Registry information

Official study title

Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2024
Registry last updated
Aug 20, 2024

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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