Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

Neonatal Disease Clinical Trial

Official title:

Multisensory Stimulation and Soft Tissue Therapy on Procedural Pain and Neurodevelopment Among Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366102
• Other study ID #: MMDU/IEC/2152
• Secondary ID: U1111-1242-9663
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: October 20, 2023

Study information

• Verified date: October 2023
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 20, 2023
• Est. primary completion date: September 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Hours to 5 Days

Eligibility

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,

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disease
• Neonatal Disorder

Intervention

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
• Routine hospital care
Routine hospital care will be given to the preterm neonates

Locations

Country	Name	City	State
India	Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital	Ambala	Haryana

Sponsors (3)

Lead Sponsor	Collaborator
Asir John Samuel	Department of Science and Technology, Government of India, Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change score of PIPP at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention
Primary	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	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	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.	Change score of INFANIB at the baseline and after five days of intervention
Secondary	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.	Change score of Premie-Neuro at the baseline and after five days of intervention

External Links

•   Effect of Multi-sensory Stimulation on Neuromuscular Development of Premature Infants: A Randomized Clinical Trial
•   Pain assessment scales in newborns: integrative review