Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

Not Applicable

Completed

• Conditions: Neonatal Disease; Neonatal Disorder
• Interventions: Other: Multisensory stimulation with soft tissue therapy; Other: Routine hospital care

• Registration Number: NCT04366102
• Lead Sponsor: Asir John Samuel

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.

Study Timeline

• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Study Start: 2020-10-22
• Primary Completion: 2023-09-16
• Study Completion: 2023-10-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-03
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Multisensory stimulation with soft tissue therapy	Multisensory stimulation and soft tissue therapy
Group B	Routine hospital care	Routine Hospital care

Primary Outcome Measures

Name	Time	Method
The Premature infant pain profile-Revised (PIPP-R)	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
Neonatal pain agitation sedation scale (N-PASS)	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 Outcome Measures

Name	Time	Method
Infant neurological international battery (INFANIB)	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.
Premie-Neuro	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.

Trial Locations

Locations (1)

Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital; 🇮🇳 Ambala, Haryana, India