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

Shifa Tameer-e-Millat University

Status: Enrolling

Conditions: Non Pharmacological Pain Management

Treatments: Other: Gentle Human Touch; Other: Facilitated Tucking

Study type: Interventional

Funder types: Other

Identifiers

NCT06415240

STMU

Details and patient eligibility

About

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

Full 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.

Enrollment: 159 estimated patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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159 participants in 3 patient groups

Facilitated Tucking

Experimental group

Description:

A non pharmacological intervention to be implemented during arterial prick.

Treatment:

Other: Facilitated Tucking

Gentle Human Touch

Experimental group

Description:

A non pharmacological intervention to be implemented during arterial prick.

Treatment:

Other: Gentle Human Touch

Usual Care

No Intervention group

Description:

Usual Care