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

NCT ID: NCT06793618

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-24

Study Completion Date

2024-12-28

Brief Summary

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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.

Detailed Description

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Conditions

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Intramuscular Injection Neonates Neonatal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized control trial with one intervention and one control group. post-test only
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Z-track technique

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.

Group Type ACTIVE_COMPARATOR

Z-track technique

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Z-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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

5 Minutes

Maximum Eligible Age

2 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Haider Jumaa Kareem

Academic Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Feminine and Children Educational Hospital

As Samawah, Al Muthanna Governorate, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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NO. 37/ 2024

Identifier Type: -

Identifier Source: org_study_id

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