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Vaccine-Related Pain in Infants

NCT02808637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2016-06-22

No results posted yet for this study

Summary

This is a randomized double-blind controlled study and was performed to compare effects of rapid injection without aspiration and 10-second manual pressure before injection on pain severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib.

The study population included all the infants presenting for DTaP/IPV/Hib to two family health centers between April and August in 2015. The study sample included 128 infants based on confidence interval of 95% and statistical power of 80%. The sample was divided into four groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined with rapid injection without aspiration and control groups. There were 32 infants in each group. Gender was adjusted in all groups. Stratified and block randomizations were used.

Conditions

Interventions

OTHER

Manual Pressure

First, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered in accordance with the conventional injection technique.

OTHER

Rapid Injection without Aspiration

First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using rapid injection without aspiration technique.

OTHER

Manual Pressure + Rapid Injection without Aspiration

First, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered by using the rapid injection without aspiration technique.

OTHER

Control

First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using the conventional injection technique.

Sponsors & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER

  • Çankırı Karatekin University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE

Eligibility

Min Age
4 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-08-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808637 on ClinicalTrials.gov