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 range

4 Months – 4 Months

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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