Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

Summary

To determine the effects of multisensory stimulation and soft tissue therapy on procedural pain and neurodevelopment among neonates admitted to the NICU is the aim of the study. The study will be two groups randomized clinical trial of five days intervention program. The intervention will be given among two groups. Group A will receive both multisensory stimulation and soft tissue therapy, Group B will receive only regular hospital care. The PIPP and N-PASS will be used for assessing pain. The INFANIB and Premie-Neuro will be used for assessing neuromotor development among neonates. The outcomes will be taken before and after the fifth day of the intervention. Multisensory stimulation and soft tissue therapy might help in reducing pain and promoting neurodevelopment.

Conditions

• Neonatal Disease
• Neonatal Disorder

Interventions

OTHER

Multisensory stimulation with soft tissue therapy

Multisensory stimulation with soft tissue therapy will be given. Multisensory stimulation consists of Auditory, vestibular, tactile, olfactive, oromotor, Visual, and Kinesthetic stimulation. Soft tissue therapy consists of stroking, effleurage, fingertip kneading, tapping, and skin rolling will be given. Total intervention will be given for 30 min. 5 times per week

OTHER

Routine hospital care

Routine hospital care will be given to the preterm neonates

Sponsors & Collaborators

• Department of Science and Technology, Government of India

  collaborator UNKNOWN

• Maharishi Markendeswar University (Deemed to be University)

  collaborator OTHER

• Asir John Samuel

  lead OTHER

Principal Investigators

• Neha Sharma, MPT · Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

• Asir J Samuel, MPT, PhD · Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

• Kusum Mahajan, MD · Maharishi Markandeshwar Institute of Medical Sciences & Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

24 Hours

Max Age

5 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-22

Primary Completion

2023-09-16

Completion

2023-10-20

Countries

• India

Study Locations