CompletedPhase 4

Effects of Shotblocker® and Manual Pressure on Pain

Turkey (Türkiye)102 participantsStarted 2022-02-15

Plain-language summary

Aim This randomized controlled experimental study was conducted to determine the effect of ShotBlocker® and manual pressure application on pain in the application of Conjugated Pneumococcal Vaccine (PCV). The following hypotheses were determined for the study; Hypothesis 1: Pain scores of infants are lower in the manual pressure group than in the control group during the administration of PCV. Hypothesis 2: Pain scores of infants are lower in Shotblocker® group than in the control group during the administration of PCV. Hypothesis 3: Manual pressure is more effective than Shotblocker® in infants to reducing pain during the administration of PCV.

Who can participate

Age range4 Months – 4 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infant who were 4 months old * who receive the pneumococcal conjugate vaccine receive * healthly infant, free from systemic illnesses * accompanied by their mothers * attending the center for routine vaccination Exclusion Criteria: * who have serious congenital malformations * who have neurodevelopmental delays * who have serious congenital malformations * who have febrile conditions * who have a history of circulatory or peripheral vascular issues * who had taken sedatives, hypnotics, or systemic pain relievers within the last 6 hours * infant who cried before receiving the vaccine

What they're measuring

Pain mean score

Timeframe: immediately after the pneumococcal conjugate vaccination

Trial details

NCT IDNCT06813729

SponsorAydin Adnan Menderes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-15

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