Intramuscular InjectionNCT06793618
Effectiveness of the Z-Track Technique As a Pain-Reducing Strategy for Neonates During Intramuscular Injection: a Randomized Controlled Trial
A study testing Z-track technique in people with Intramuscular Injection and Neonates, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 minutes to 2 hours
- Conditions the study is for
- Intramuscular Injection, Neonates, Neonatal Pain
- What is being tested?
- Z-track technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteIraq
- Study dates
- 24 Nov 2024to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 minutes to 2 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Feminine and Children Educational Hospital
Samawah, Muthanna Governorate, 66001
About this study
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
- Being tested
- Z-track technique
- Keywords
- Pain, non-pharmacological pain managment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-track techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the process of enrollment at the post-natal ward until the IM injection is administered (usually takes less than 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start24 Nov 2024
- Primary completion27 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intramuscular InjectionStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control trial with one intervention and one control group. post-test only
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haider Jumaa Kareem, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793618
- Sponsor's protocol ID
- NO. 37/ 2024
- Status last verified
- Feb 2025
- First submitted
- 20 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Z-Track Technique As a Pain-Reducing Strategy for Neonates During Intramuscular Injection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06793618
- Acronym / sponsor ID
- NO. 37/ 2024
- Conditions
- Intramuscular Injection, Neonates, Neonatal Pain
- Keywords
- Pain, non-pharmacological pain managment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized control trial with one intervention and one control group. post-test only
| Arm | Type | Receives |
|---|---|---|
| Z-track technique | Active comparator | Other: Z-track techniqueTo 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. |
| Control group | No intervention | –the neonates receive the intramuscular injection using the conventional method and protocol used in the postnatal ward without any interventions |
Who may qualify
- Ages
- 5 minutes to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Neonates delivered through cesarean section
- Apgar score of 8 or more
- Weight between 2500 - 3500 grams
- neonates receiving IM injections
- Males / females
Key exclusion criteria (6 listed)
- Congenital anomalies
- neonates who received intramuscular injection such as the Hepatitis B vaccine
- Low birth weight
- Preterms
- Neural tube defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z-track techniqueIn 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Z-track technique in people with Intramuscular Injection and Neonates, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.