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Neonatal DiseaseNCT04366102

Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

A study testing Multisensory stimulation with soft tissue therapy and Routine hospital care in people with Neonatal Disease and Neonatal Disorder, run by Asir John Samuel at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 hours to 5 daysHealthy volunteers can take part
Conditions the study is for
Neonatal Disease, Neonatal Disorder
What is being tested?
Multisensory stimulation with soft tissue therapy and Routine hospital care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteIndia
Study dates
22 Oct 2020to 20 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 hours to 5 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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,

Trial locations and contacts

1 site in 1 country.

India1 site

  • Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

    Ambāla, Haryana, 133207

Other trials in India

About this study

Official title: 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.

Read the 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.

Being tested
Multisensory stimulation with soft tissue therapy, Routine hospital care
Keywords
Neonates, Pain
Medical subject headings
Infant, Newborn, Diseases, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multisensory stimulation with soft tissue therapyOther

    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

  • Routine hospital careOther

    Routine hospital care will be given to the preterm neonates

Study groups in NCT04366102
Study groupRoleWhat they receive
Group AExperimentalMultisensory stimulation and soft tissue therapy
Receives: Other: Multisensory stimulation with soft tissue therapy
Group BExperimentalRoutine Hospital care
Receives: Other: Routine hospital care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Premature infant pain profile-Revised (PIPP-R)

    Measuring procedural pain among neonates, having 1 to 3 scoring. 0 describe normal and 3 describes low score

    Measured: Change score of PIPP at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention

  2. Neonatal pain agitation sedation scale (N-PASS)

    Measuring procedural pain along with sedation, having score ranged from 0 to 2, 0 describes normal and 2 describes low score

    Measured: 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 outcomes (2)

  1. Infant neurological international battery (INFANIB)

    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.

    Measured: Change score of INFANIB at the baseline and after five days of intervention

  2. Premie-Neuro

    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.

    Measured: Change score of Premie-Neuro at the baseline and after five days of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start22 Oct 2020
  3. Primary completion16 Sep 2023
  4. Study completion20 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Neonates admitted in the Neonatal intensive care unit will be divided randomly into 2 groups.
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04366102
Sponsor's protocol ID
MMDU/IEC/2152
Other IDs
U1111-1242-9663
Status last verified
Aug 2024
First submitted
25 Apr 2020
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will be shared via Mendeley Dataset

Publications

  • Zeraati H, Nasimi F, Rezaeian A, Shahinfar J, Ghorban Zade M. Effect of Multi-sensory Stimulation on Neuromuscular Development of Premature Infants: A Randomized Clinical Trial. Iran J Child Neurol. 2018 Summer;12(3):32-39.

    PubMed 30026767

  • de Melo GM, Lelis AL, de Moura AF, Cardoso MV, da Silva VM. [Pain assessment scales in newborns: integrative review]. Rev Paul Pediatr. 2014 Dec;32(4):395-402. doi: 10.1016/j.rpped.2014.04.007.

    PubMed 25511005

  • Sharma N, Samuel AJ. Multisensory Stimulation and Soft Tissue Therapy on Pain and Neurodevelopment Among Preterm Neonates. Pediatr Phys Ther. 2022 Apr 1;34(2):277-282. doi: 10.1097/PEP.0000000000000887.

    PubMed 35385466

Questions about this trial

What is this clinical trial studying?

A study testing Multisensory stimulation with soft tissue therapy and Routine hospital care in people with Neonatal Disease and Neonatal Disorder, run by Asir John Samuel at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04366102, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.

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