Clinical trial NCT04366102: Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates
Official title: Multisensory Stimulation and Soft Tissue Therapy on Procedural Pain and Neurodevelopment Among Preterm Neonates (MUST-P3) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Disease
Neonatal Disorder
Keywords: Neonates
Pain
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
Collaborators: name: Department of Science and Technology, Government of India
name: Maharishi Markendeswar University (Deemed to be University)
First posted: 2020-04-28
Enrollment: 68
Sex: ALL
Minimum age (years): 24
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Neonates admitted in the Neonatal intensive care unit will be divided randomly into 2 groups.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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,

Primary outcomes:
measure: The Premature infant pain profile-Revised (PIPP-R)
timeFrame: Change score of PIPP at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention
measure: Neonatal pain agitation sedation scale (N-PASS)
timeFrame: 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:
measure: Infant neurological international battery (INFANIB)
timeFrame: Change score of INFANIB at the baseline and after five days of intervention
measure: Premie-Neuro
timeFrame: Change score of Premie-Neuro at the baseline and after five days of intervention
Other outcomes:
Locations:
city: Ambala
country: India
facility: Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
name: Neha Sharma, MPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
name: Asir J Samuel, MPT, PhD
role: STUDY_CHAIR
affiliation: Maharishi Markandeshwar Institute of Medical Sciences & Research
name: Kusum Mahajan, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.