A clinical trial to study the effect of vibratory therapy in decreasing the vaccination induced pain in Infants
Not Applicable
- Registration Number
- CTRI/2021/02/031015
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•Lack of any diseases,
•Not on any medication
•Exclusive breastfeeding Infant
•Comes for Vaccination
•Written informed consent given by the parents
Exclusion Criteria
•If the infant is crying and will not get calm
•Acute febrile illness
•Chronic medical conditions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To measure the pain intensity with the help of NIPS scoreTimepoint: End of the study treatment phase that lasts for one hours in total
- Secondary Outcome Measures
Name Time Method The secondary outcome will be the mean difference in level of distress during the vaccine-related procedure between groups. It will be assessed immediately after the vaccination procedure attempt using the Color Analogue Scale (CAS). Mean differences between groups on distress scores during the vaccination procedure will be assessed using MBPS and FLACC scale.Timepoint: End of the study treatment phase that lasts for one hours in total