Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

Asir John Samuel

Status: Completed

Conditions: Neonatal Disorder; Neonatal Disease

Treatments: Other: Routine hospital care; Other: Multisensory stimulation with soft tissue therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04366102

U1111-1242-9663

MMDU/IEC/2152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 24 hours to 5 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Group A

Experimental group

Description:

Multisensory stimulation and soft tissue therapy

Treatment:

Other: Multisensory stimulation with soft tissue therapy

Group B

Experimental group

Description:

Routine Hospital care

Treatment:

Other: Routine hospital care