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

NCT ID: NCT06762938

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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ShotBlocker

Group Type EXPERIMENTAL

ShotBlocker

Intervention Type BEHAVIORAL

Apply ShotBlocker

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ShotBlocker

Apply ShotBlocker

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Veysel Can

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Van Yüzüncü Yıl University

Van, Tuşba, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ShotBlocker

Identifier Type: -

Identifier Source: org_study_id

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