Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

Study Overview
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Brief Summary
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Hyperbilirubinemia is the commonest problem seen in neonates, owing to severe complications in lifetime. The study design of the study is pretest - posttest experimental design. Convenience Sampling will be used for recruiting the neonates. In study neonates will be selected according to the selection criteria and will be allocated into two groups in 1: 1 ratio, Intervention group - neonates will receive tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hours after feed twice daily along with Phototherapy, Control group - Phototherapy alone will be given. Total serum bilirubin and weight gain will be assessed as outcome measure daily once. Transcutaneous bilirubin will be assessed before and after every intervention.

Official Title
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Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia

Conditions
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Neonatal Hyperbilirubinemia

Intervention / Treatment
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* Other: Massage therapy
* Other: Kinaesthetic stimulation


Participation Criteria
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Eligibility Criteria
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New born in Neonatal Intensive Care Unit Stable vitals Full Term and Preterm neonates Gestational age 34 weeks to 40 weeks Birth weight -1800 - 2500 g APGAR Score at birth of 8 -10 Total serum bilirubin levels > 5mg/dL

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Neonates recruited in experimental group will receive massage therapy and kinaesthetic stimulation for 15 minutes along with phototherapy for consecutive days . It will be given in three phases first massage therapy will be given for 5 minutes, followed by movement of limbs for 5 minutes and then again massage therapy will be repeated for 5 minutes. | Other: Massage therapy<br>* Massage therapy includes stroking, kneading, rolling, tapping, vibration and effleurage over the face, chest ,abdomen and back. Massage therapy will be given for 5 minutes and will be repeated twice.<br>Other: Kinaesthetic stimulation<br>* Kinaesthetic stimulation includes passive flexion and extension movements of shoulder joint, elbow joint, hip joint, knee joint and both lower limbs together. It will be given for 5 minutes in each intervention<br>|
| No Intervention: Control Group<br>Neonates recruited in control group will receive phototherapy alone along with regular care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Serum Bilirubin (TSB) | It will measure total bilirubin level in blood of neonates | Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention | 
| Transcutaneous Bilirubin (TcB) | Transcutaneous Bilirubin will measure neonatal jaundice. | Changes in the Transcutaneous Bilirubin level will be measured daily for three days before and after intervention | 
| Weight Gain | Weight gain will evaluate the change in neonatal weight | Changes in the weight will be measured at baseline and at the end of three days intervention |