"The Effect of Snow Globe Used in Infancy Vaccination Applications on Pain Level."

NCT04772430 | Unknown

• 1 other identifier: 12102020100140
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research is to determine the effect of the snow globe, which is used as a method of diverting attention, to the perception of pain that develops during the application of vaccines in infants between 2-6 months of age.

Conditions

Pain

Keywords

pain; immunization; diverting attention; infancy

Outcome Measures

Primary Outcomes (1)

• Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale

  Flacc pain scale score is obtained by evaluating in five categories as facial expression, leg movements, activity, crying and consolingness. By giving 0, 1, or 2 points for each category, the total score between 0 and 10 is reached. As the pain intensity increases, the total score increases, as the pain intensity decreases, the total score decreases

  2-6 months

Secondary Outcomes (3)

• Heart rate

  2-6 months

• oxygen saturation

  2-6 months

• crying duration of babies

  2-6 months

Study Arms (2)

Control group

NO INTERVENTION

The baby whose height and weight measurements will be taken will be taken to the stretcher, and the vaccine will be administered after the pain score is measured before the procedure. Pain scores will be recorded during and after the procedure

Experimental group

EXPERIMENTAL

The baby whose height and weight measurements will be taken will be taken to the stretcher, after the pain score is measured before the procedure, the snow globe will be operated and the vaccine will be applied. The snow globe will continue to work until the application is completed. Pain scores will be recorded during and after the procedure.

Radiation: snow globe

Interventions

snow globe RADIATION

Control group; The baby whose height and weight measurements will be taken will be taken to the stretcher, and the vaccine will be administered after the pain score is measured before the procedure. Pain scores will be recorded during and after the procedure. Experimental group; The baby whose height and weight measurements will be taken will be taken to the stretcher, after the pain score is measured before the procedure, the snow globe will be operated and the vaccine will be applied. The snow globe will continue to work until the application is completed. Pain scores will be recorded during and after the procedure.

Experimental group

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being registered at Bartın Family Health Center
• Being in the age range of 2-6 months
• Having parental consent
• Does not have a congenital or chronic health problem,
• Not taking an analgesic drug in the last 4 hours,
• Infants of families who have accepted to participate in the study and signed the informed consent form will be included in the study

You may not qualify if:

• Being aged between 0-1 months and over 6 months,
• No parental consent,
• Using analgesics in the last 4 hours,
• The child has a congenital or chronic health problem

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Betül Akkoç

Merkez, Bartın, 74000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zonguldak Bulent Ecevit University

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 26, 2021
• Study Start: August 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: April 1, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)