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

May 15, 2024 updated by: Nazma Hamid, Shifa Tameer-e-Millat University

Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Shifa Tameer E Millat University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Facilitated Tucking
A non pharmacological intervention to be implemented during arterial prick.
Other: Facilitated Tucking
Facilitated Tucking is a position to be adopted for pain relief in neonates.
Experimental: Gentle Human Touch
A non pharmacological intervention to be implemented during arterial prick.
Other: Gentle Human Touch
while gentle human touch is caressing on head for pain relief.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before,During Arterial Prick and after three minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shifa Tameer-e-Millat University

Investigators

  • Principal Investigator: Nazma Hamid, MSN, Shifa Tameer E Millat Univesrity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not intended

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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