NCT06762938

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

December 31, 2024

Last Update Submit

January 7, 2025

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Face, Legs, Activity, Crying, Consolability Pain Scala

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

    pre-test post-test (approximately three months)

Study Arms (2)

ShotBlocker

EXPERIMENTAL
Behavioral: ShotBlocker

Control

NO INTERVENTION

Interventions

ShotBlockerBEHAVIORAL

Apply ShotBlocker

ShotBlocker

Eligibility Criteria

Age12 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University

Van, Tuşba, 65000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 8, 2025

Study Start

August 1, 2024

Primary Completion

November 20, 2024

Study Completion

November 30, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)