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Completed

NCT Number: NCT06762938

The Effect of ShotBlocker on Pain and Satisfaction During Measles-Rubella-Mumps Vaccination

Objective The aim of this study was to evaluate the effects of ShotBlocker administration during measles-mumps-rubella (MMR) vaccination on infants' pain level and mothers' satisfaction.

Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between August and October 2024 using a randomized controlled experimental design. The study sample consisted of 60 infants who received MMR vaccination (ShotBlocker group: n = 30, control group: n = 30). Infants in the ShotBlocker group received ShotBlocker before vaccine injection, while infants in the control group received only routine vaccine injection. Infant information form, FLACC pain scale and Newcastle Satisfaction with Nursing Care Scale were used for data collection. Ethical principles were followed throughout the study.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yüzüncü Yıl University

Van, Tuşba, 65000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • He's 12 months old,
  • MMR vaccine will be administered,
  • growth-development is normal,
  • no analgesic medication was given during the day,
  • at least high school graduate
  • mothers who volunteered to participate in the study

Exclusion criteria

  • Neurological disease,
  • a chronic disease,
  • allergy (egg allergy)
  • infants with symptoms of hyperthermia

Treatment and study plan

ShotBlocker

Behavioral

Apply ShotBlocker

Primary outcomes

  1. Face, Legs, Activity, Crying, Consolability Pain Scala

    Time frame: pre-test post-test (approximately three months)

    min-max (0-10), lower score means better result, reduce scale scores

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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