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Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants

Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03222050
Enrollment
100
Registered
2017-07-19
Start date
2015-11-30
Completion date
2017-01-31
Last updated
2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

Sponsors

Maharishi Markendeswar University (Deemed to be University)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Weeks to 14 Weeks
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Flacc pain score5 minuteFlacc pain score Level of pain: 0 - No distress/Pain 1-3 - Mild distress/Pain 4-7 - Moderate distress/Pain 8-10 - Severe distress/Pain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026