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Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Distraction technique
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

10 Weeks - 14 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    electronic toy group

    key toy group

    Simple toy group

    control group

    Arm Description

    Distraction technique was given by electronic toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds

    Distraction technique was given by key toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds

    Distraction technique was given by simple toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds

    Routine care was given during immunization and no intervention was given

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 17, 2017
    Last Updated
    July 17, 2017
    Sponsor
    Maharishi Markendeswar University (Deemed to be University)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03222050
    Brief Title
    Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants
    Official Title
    Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maharishi Markendeswar University (Deemed to be University)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    electronic toy group
    Arm Type
    Experimental
    Arm Description
    Distraction technique was given by electronic toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds
    Arm Title
    key toy group
    Arm Type
    Experimental
    Arm Description
    Distraction technique was given by key toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds
    Arm Title
    Simple toy group
    Arm Type
    Experimental
    Arm Description
    Distraction technique was given by simple toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Routine care was given during immunization and no intervention was given
    Intervention Type
    Other
    Intervention Name(s)
    Distraction technique
    Primary Outcome Measure Information:
    Title
    Flacc pain score
    Description
    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
    Time Frame
    5 minute

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Weeks
    Maximum Age & Unit of Time
    14 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    1. Hockenberry Marilyn. Wong's Essentials of Pediatric Nursing. 7th Edition. New Delhi. Elsevier Publication (P) Ltd. 2007; 235-238.
    Results Reference
    background
    Citation
    2. Wong DL, Hocken MJ. Nursing care of infants and children and adolescents. Agency for Healthcare Policy and Research Publication. 1992.
    Results Reference
    background
    Citation
    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.
    Results Reference
    result

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    Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants

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