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

NCT06415240 | Recruiting DMC

• 1 other identifier: STMU
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Non Pharmacological Pain Management

Keywords

Non Pharmacological Pain Management; Neonates; Procedural Pain

Outcome Measures

Primary Outcomes (1)

• Neonatal Infant Pain Scale

  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

  Before,During Arterial Prick and after three minutes

Study Arms (3)

Facilitated Tucking

EXPERIMENTAL

A non pharmacological intervention to be implemented during arterial prick.

Other: Facilitated Tucking

Gentle Human Touch

EXPERIMENTAL

A non pharmacological intervention to be implemented during arterial prick.

Other: Gentle Human Touch

Usual Care

NO INTERVENTION

Usual Care

Interventions

Facilitated Tucking OTHER

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

Facilitated Tucking

Gentle Human Touch OTHER

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

Gentle Human Touch

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shifa Tameer-e-Millat University: lead

Study Sites (2)

Pakistan Institute of Medical Sciences

Islamabad, 44000, Pakistan

RECRUITING

Shifa Tameer E Millat University

Islamabad, 44000, Pakistan

NOT YET RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Interventions

Facilitated Tucking

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nazma Hamid, MSN

  Shifa Tameer E Millat Univesrity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazma Hamid, MSN

CONTACT

03421547629; nazmahamid07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: As participants are neonates, they are not able to judge any intervention. Data is being collected by an independent data collector and pain scoring is also planned to be done by an independent Research Assistant. So, an investigator is masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Nurse Manager

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 20, 2024
• Primary Completion: September 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)