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Clinical Trials/CTRI/2020/12/029710
CTRI/2020/12/029710Not yet recruitingNot Applicable

TO ASSESS THE EFFICACY OF VIBRATION DEVICE IN REDUCTION OF INJECTION PAIN AMONG CHILDREN

Prof Archana Maurya1 site in 1 country400 target enrollmentStarted: January 1, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
assess anxiety level through Children’s emotional behaviour scale

Study Overview

Brief Summary

To assess the efficacy of Vibration device in reduction of Injection pain in children. This study is a randomized, participant blinde, sealed opaque envelope, two group one control group and interventional trail comparing assess the pain level, anxiety level respiration heart rate and SpO2 . Study have three phases –1.  ASSESSMENT & PLANNING PHASE: The investigator will visit the AVBR hospital in advance and obtain the necessary permission from the concerned authorities. The investigator will introduce him and inform the child’s parent about the nature of the study so as to ensure better co-operation during the data collection.**2.****IMPLEMENTATION PHASE:**Vibration device is placed by attaching it to the injection site holding it in place, as close as possible above the needle insertion site and activate The device has to be kept in place throughout the procedure In experimental group and control group, only rub by palm on injection site no intervention will be given during administration of injection in children.3. EVALUATION PHASE: The outcome measures pain in children during injection and were recorded and assessed by a blinded observer.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

Ages
8.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Child who are in pediatric unit.
  • Those children are fully conscious.
  • Parent’s who have willing to their child participate in study.

Exclusion Criteria

  • Those children are admitted in PICU with ventilator support.
  • Those children are mentally handicaps.
  • Extensive hospitalization for chronic illness Those children having neuro-behaviour disorders (Paralysis, Cerebral palsy) Those children having behaviour problem (Autism, temper tantrum, ADHD).
  • Those children having injection side abscess or any complication.
  • Past history of surgery.

Outcomes

Primary Outcomes

assess anxiety level through Children’s emotional behaviour scale

Time Frame: Before, during and after injection

assess reduction of injection pain in children (Wong-Baker FACES pain rating scale).

Time Frame: Before, during and after injection

Secondary Outcomes

  • Pulse or Heart Rate(SpO2 saturation)

Investigators

Sponsor
Prof Archana Maurya
Sponsor Class
Other [Other [Self sponsored]]

Study Sites (1)

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