Effectiveness of the Z-Track Technique As a Pain-Reducing Strategy for Neonates During Intramuscular Injection: a Randomized Controlled Trial

NCT06793618 | Completed

• 1 other identifier: NO. 37/ 2024
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

A quantitative study, true experimental, posttest-only design has been used for the current study. one intervention (the Z-track technique) and one control group involved in the study. The primary outcome measure is the Neonatal/Infant Pain Scale to be used immediately after intramuscular injections to measure the pain level among neonates.

Conditions

Intramuscular Injection; Neonates; Neonatal Pain

Keywords

Pain; non-pharmacological pain managment

Outcome Measures

Primary Outcomes (1)

• Neonatal/ Infant Pain Scale

  A scale developed specifically for newborn infants. Consists of 6 criterion (Face Expression, cry, Patterns of Breathing, leg and arm movements, Arousal status) Recommended for children less than 1 year old.

  from the process of enrollment at the post-natal ward until the IM injection is administered (usually takes less than 1 hour)

Study Arms (2)

Z-track technique

ACTIVE COMPARATOR

To perform the zeta-track technique: In this method, the neonates are in supine position, the skin is moved and held from the injection site 2 to 3 cm to the side or downward using the non- dominant hand, to ensure that blood vessel wasn't penetrated aspiration on the syringe must perceive the injection and then the medication is to be injected slowly. Researcher assistant that is unaware of the injection method performs the recording of the pain intensity and leakage diameter on the observation form.

Other: Z-track technique

Control group

NO INTERVENTION

the neonates receive the intramuscular injection using the conventional method and protocol used in the postnatal ward without any interventions

Interventions

Z-track technique OTHER

In this method, the neonates are in supine position, the skin is moved and held from the injection site 2 to 3 cm to the side or downward using the non- dominant hand, to ensure that blood vessel wasn't penetrated aspiration on the syringe must perceive the injection and then the medication is to be injected slowly. Researcher assistant that is unaware of the injection method performs the recording of the pain intensity and leakage diameter on the observation form.

Z-track technique

Eligibility Criteria

• Age: 5 Minutes - 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates delivered through cesarean section
• Apgar score of 8 or more
• Weight between 2500 - 3500 grams
• neonates receiving IM injections
• Males / females
• term neonates between 37th and 42nd week of gestation

You may not qualify if:

• Congenital anomalies
• neonates who received intramuscular injection such as the Hepatitis B vaccine
• Low birth weight
• Preterms
• Neural tube defects
• neonates who are of normal vaginal delivery

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Feminine and Children Educational Hospital

Samawah, Muthanna Governorate, 66001, Iraq

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Nurse

Model Details: A randomized control trial with one intervention and one control group. post-test only

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: November 24, 2024
• Primary Completion: December 27, 2024
• Study Completion: December 28, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)