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Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants

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ClinicalTrials.gov Identifier: NCT03222050
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Preeti dabas, Maharishi Markendeswar University (Deemed to be University)

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.

Condition or disease Intervention/treatment Phase
Pain Other: Distraction technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants
Actual Study Start Date : November 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: electronic toy group
Distraction technique was given by electronic toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds
Other: Distraction technique
Experimental: key toy group
Distraction technique was given by key toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds
Other: Distraction technique
Experimental: Simple toy group
Distraction technique was given by simple toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds
Other: Distraction technique
No Intervention: control group
Routine care was given during immunization and no intervention was given



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   10 Weeks to 14 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Publications of Results:
9. 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.

Other Publications:
1. Hockenberry Marilyn. Wong's Essentials of Pediatric Nursing. 7th Edition. New Delhi. Elsevier Publication (P) Ltd. 2007; 235-238.
2. Wong DL, Hocken MJ. Nursing care of infants and children and adolescents. Agency for Healthcare Policy and Research Publication. 1992.

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Responsible Party: Preeti dabas, Student, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier: NCT03222050    
Other Study ID Numbers: 777
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain
Neurologic Manifestations