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

Not Applicable

Recruiting

• Conditions: Non Pharmacological Pain Management
• Interventions: Other: Facilitated Tucking; Other: Gentle Human Touch

• Registration Number: NCT06415240
• Lead Sponsor: Shifa Tameer-e-Millat University

Brief Summary

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.

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Study Start: 2024-05-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-09-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

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

Exclusion Criteria

1. Documented birth asphyxia
2. Congenital anomalies
3. Neurological diagnosis,
4. ventilated with paralysis
5. Extremely premature newborns (Gestational age < 28 weeks)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facilitated Tucking	Facilitated Tucking	A non pharmacological intervention to be implemented during arterial prick.
Gentle Human Touch	Gentle Human Touch	A non pharmacological intervention to be implemented during arterial prick.

Primary Outcome Measures

Name	Time	Method
Neonatal Infant Pain Scale	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

Trial Locations

Locations (2)

Shifa Tameer E Millat University; 🇵🇰 Islamabad, Pakistan

Pakistan Institute of Medical Sciences; 🇵🇰 Islamabad, Pakistan