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Clinical Trials/NCT06793618
NCT06793618CompletedNot Applicable

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

University of Baghdad1 site in 1 country147 target enrollmentStarted: November 24, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
147
Locations
1
Primary Endpoint
Neonatal/ Infant Pain Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
5 Minutes to 2 Hours (Child)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Neural tube defects
  • •neonates who are of normal vaginal delivery

Arms & Interventions

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.

Intervention: Z-track technique (Other)

Control group

No Intervention

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

Outcomes

Primary Outcomes

Neonatal/ Infant Pain Scale

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Haider Jumaa Kareem

Academic Nurse

University of Baghdad

Study Sites (1)

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