Vaccine-Related Pain in Infants
Condition: Pain
Study type: Interventional

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.
    

Detailed description: 
      Study design: this is an experimental, double-blind, randomized controlled trial.

      Study population and study sample: The study was conducted in two family health centers of
      Cankiri Public Health Directorate, Turkey, between April and August in 2015. The study
      population included infants aged 4-6 months and presenting to the family health centers for
      the second and third doses of DTaP/IPV/Hib. The study sample comprised of 128 infants based
      on confidence interval of 95% and statistical power of 80%. Analysis made at the end of the
      study showed a statistical power of 0.83 based on confidence interval of 95%.

      Outcome Measures

      Pain severity: Video recordings obtained were evaluated by two pain specialists separately by
      using Neonatal Infant Pain Scale. The specialists were blinded to the groups to eliminate
      possible mistakes in observations and the possibility of taking sides and to avoid bias. The
      scores assigned by the specialists were used to determine pain scores before, during and
      after vaccine injections.

      Crying time: Video recordings taken were watched by the same researcher and crying time
      before, during and after vaccine injections was calculated for each infant.

      Physiological Changes (heart rate and oxygen saturation): the probe of pulse oximetry was
      attached to the foot not injected vaccine to measure oxygen saturation and heart rate before,
      during and after the injections in each child.
    

Intervention name(s): Manual Pressure; Rapid Injection without Aspiration; Manual Pressure + Rapid Injection without Aspiration; Control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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.; First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using rapid injection without aspiration technique.; 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.; First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using the conventional injection technique.
Allocation: Randomized
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pain management; vaccination; manual pressure; needle aspiration