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Clinical Trials/NCT03222050
NCT03222050
Completed
Not Applicable

Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants

Maharishi Markendeswar University (Deemed to be University)0 sites100 target enrollmentNovember 2015
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Maharishi Markendeswar University (Deemed to be University)
Enrollment
100
Primary Endpoint
Flacc pain score
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

A study to assess and compare the effectiveness of Distraction techniques on Pain intensity during Immunization among Infants in selected hospital of Ambala, Haryana.

Detailed Description

Immunization is an important part of public health intervention and cost effective strategy to control the infectious diseases especially in children and it is one of the most common painful procedure in infants. Pain during immunization leads to distressing experience for the infant, parents and health care worker. Distraction is non pharmacological method which is used for diverting attention from noxious stimulus by passively redirecting the attention or by actively performed by the subject in the performance of diversion technique. Aim and objectives:The aim of present study was to compare the effectiveness of distraction techniques on pain intensity during immunization among infants. The objectives of the study were to assess and compare the mean pain scores among infants receiving immunization in electronic toy group, key toy group, simple toy group and control group and to find out the association of pain scores among infants receiving immunization with their selected variables. Material and methods: A true experimental multiple intervention post test control design was used. There were 100 infants selected using simple random sampling technique and were randomly allocated in various groups such as electronic toy group, key toy group, simple toy group and control group using lottery method. During immunization, distraction techniques were shown to experimental groups and routine care was given to control group. Research tool was submitted to 7 experts from various specialists for validity. Reliability was calculated by Kappa method and it was 0.83 of FLACC pain scale to assess pain intensity during immunization among infants. Data collection was done in January 2017. The obtained data was analyzed and interpreted in terms of objectives and research hypotheses. Analysis was done by using descriptive and inferential statistics.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
January 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Maharishi Markendeswar University (Deemed to be University)
Responsible Party
Principal Investigator
Principal Investigator

Preeti dabas

Student

Maharishi Markendeswar University (Deemed to be University)

Eligibility Criteria

Inclusion Criteria

  • • Infants who were-visiting immunization clinics of Civil Hospital for immunization.
  • having 10 and 14 weeks of age. receiving pentavalent vaccine. Parents and caregivers who were willing to give consent

Exclusion Criteria

  • The study excluded infants who: had undergone any painful procedure 2 hour prior to immunization, were visually or hearing disabled.
  • had history of seizures, use of topical anesthetics at immunization site, use of sedatives, analgesics or opioids in the preceding 24 hours.

Outcomes

Primary Outcomes

Flacc pain score

Time Frame: 5 minute

Flacc pain score Level of pain: 0 - No distress/Pain 1-3 - Mild distress/Pain 4-7 - Moderate distress/Pain 8-10 - Severe distress/Pain

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