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NCT Number: NCT04366102

Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

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.

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Key information

Conditions

Neonatal Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Neonatal Disorder Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

24 hour–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Ambāla, Haryana, 133207, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Multisensory stimulation with soft tissue therapy

Other

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 care

Other

Routine hospital care will be given to the preterm neonates

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Asir John Samuel

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2020
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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