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A clinical trial to study the effect of vibratory therapy in decreasing the vaccination induced pain in Infants

The Effect of Vibratory Therapy to decrease the vaccination induced pain in Infants: Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031015
Enrollment
90
Registered
2021-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Vibratory therapy: Vibratory therapy: Participants in the experimental group will receive the Vibratory therapy (VT) intervention. The vibratory therapy will be given for about 30-60 se

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: • If the infant is crying and will not get calm • Acute febrile illness • Chronic medical conditions

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactAmar Taksande

DMIMS ( Deemed to be University )

amar.taksande@gmail.com917152-287705

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026