Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Nov 2015
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
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 17, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedJuly 19, 2017
July 1, 2017
1.2 years
July 17, 2017
July 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Flacc pain score
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
5 minute
Study Arms (4)
electronic toy group
EXPERIMENTALDistraction technique was given by electronic toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds
key toy group
EXPERIMENTALDistraction technique was given by key toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds
Simple toy group
EXPERIMENTALDistraction technique was given by simple toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds
control group
NO INTERVENTIONRoutine care was given during immunization and no intervention was given
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
1. Hockenberry Marilyn. Wong's Essentials of Pediatric Nursing. 7th Edition. New Delhi. Elsevier Publication (P) Ltd. 2007; 235-238.
BACKGROUND2. Wong DL, Hocken MJ. Nursing care of infants and children and adolescents. Agency for Healthcare Policy and Research Publication. 1992.
BACKGROUND9. Sharma Rimple, Kaur Charanjit. A Randomized control trial to assess the effect of distraction technique on pain during immunization among infants. International journal of current research. June 2014:6:7119-7123.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Student
Study Record Dates
First Submitted
July 17, 2017
First Posted
July 19, 2017
Study Start
November 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
July 19, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share