Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

August 3, 2024 updated by: Asir John Samuel

Multisensory Stimulation and Soft Tissue Therapy on Procedural Pain and Neurodevelopment Among Preterm Neonates (MUST-P3) Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will utilize two parallel groups, randomised design to analyze the effects of soft tissue therapy and multisensory stimulation on pain and neurodevelopment. 104 neonates admitted in NICU will be recruited through purposive sampling for the trial. Procedural pain will be assessed with PIPP and N-PASS through recorded video. Neurodevelopmental outcomes will be assessed with INFANIB Scale and Premie-Neuro. The measurements will be taken after 24 hours of birth at the baseline and after the fifth day of the intervention. The treatment will be given into two groups i.e. Group A (Multisensory stimulation and soft tissue therapy group), Group B (routine hospital care). MSS will consist of Auditory Stimulation, Tacto-Kinesthetic stimulation, Vestibular stimulation, Visual stimulation, Oral-stimulation, and Olfactive stimulation. Soft tissue therapy consisted of stroking, effleurage, skin rolling, and kneading techniques, Will be given in 5 Phases-Forehead and face, Back and Neck, Chest and abdomen, upper-lower limbs. Total 30 min. of the treatment plan, per day, will be given to the neonates, after 30 min. of feed, for up to 5 days of NICU stay.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Ambala, Haryana, India, 133207
        • Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 5 days (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Preterm between 30- 36 weeks of gestation
  • Birth weight >1000 g
  • Not receiving analgesics/sedatives
  • APGAR score ranged between 4-6 in 1 min. & 7 to 9 in 5 min.
  • Undergoing routine healthcare procedures in NICU

Exclusion Criteria

  • Preterm with surgery
  • Preterm having unstable vitals
  • Preterm with congenital malformations
  • Preterm who require mechanical ventilation
  • Having inborn errors of metabolism and also with seizures disorders,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Multisensory stimulation and soft tissue therapy
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
Experimental: Group B
Routine Hospital care
Other: Routine hospital care
Routine hospital care will be given to the preterm neonates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Premature infant pain profile-Revised (PIPP-R)
Time Frame: Change score of PIPP at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention
Measuring procedural pain among neonates, having 1 to 3 scoring. 0 describe normal and 3 describes low score
Change score of PIPP at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention
Neonatal pain agitation sedation scale (N-PASS)
Time Frame: Change score of N-PASS at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention
Measuring procedural pain along with sedation, having score ranged from 0 to 2, 0 describes normal and 2 describes low score
Change score of N-PASS at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant neurological international battery (INFANIB)
Time Frame: Change score of INFANIB at the baseline and after five days of intervention
Measuring neurodevelopmental outcomes among preterm neonates. Scoring is from 5, 3, and 1. Score 5 means Normal, score 3 means mildly abnormal, score 1 means markedly abnormal. Total score for preterm neonate is 70.
Change score of INFANIB at the baseline and after five days of intervention
Premie-Neuro
Time Frame: Change score of Premie-Neuro at the baseline and after five days of intervention
Premie-neuro used for measuring neurodevelopmental outcome in preterm neonates between 23 and 37 weeks of gestation. It has total 24 items. Each item has a score of 1,3, and 5. Total score is 120. Score less than 70 is considered as abnormal, score between 70-99 is questionable, and score above 100 is normal.
Change score of Premie-Neuro at the baseline and after five days of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asir John Samuel

Collaborators

Maharishi Markendeswar University (Deemed to be University)
Department of Science and Technology, Government of India

Investigators

  • Principal Investigator: Neha Sharma, MPT, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
  • Study Chair: Asir J Samuel, MPT, PhD, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
  • Study Chair: Kusum Mahajan, MD, Maharishi Markandeshwar Institute of Medical Sciences & Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2020

Primary Completion (Actual)

September 16, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

April 25, 2020

First Submitted That Met QC Criteria

April 25, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMDU/IEC/2152
  • U1111-1242-9663 (Other Identifier: Universal Trial Number (UTN)-WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) will be shared via Mendeley Dataset

IPD Sharing Time Frame

Study Protocol - December, 2020 Statistical Analysis Plan (SAP) - December, 2020 Informed Consent Form (ICF) - December, 2020

IPD Sharing Access Criteria

By publishing study protocol with detailed statistical Analysis Plan in SCOPUS and PubMed indexed journals

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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