Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-22

Study Completion Date

2023-10-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neonatal Disease Neonatal Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Neonates admitted in the Neonatal intensive care unit will be divided randomly into 2 groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Multisensory stimulation and soft tissue therapy

Group Type EXPERIMENTAL

Multisensory stimulation with soft tissue therapy

Intervention Type 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

Group B

Routine Hospital care

Group Type EXPERIMENTAL

Routine hospital care

Intervention Type OTHER

Routine hospital care will be given to the preterm neonates

Interventions

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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

Intervention Type OTHER

Routine hospital care

Routine hospital care will be given to the preterm neonates

Intervention Type OTHER

Eligibility Criteria

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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,

Minimum Eligible Age

24 Hours

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes