Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

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

2022-04-01

Study Completion Date

2024-01-11

Brief Summary

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Hyperbilirubinemia is the most common problem seen in neonates, owing to severe complications in their lifetime. The study design of the study is pretest - a posttest experimental design. Criterion-based purposive sampling will be used for recruiting the neonates. In the study neonates will be selected according to the selection criteria and will be allocated into two groups using computer-based randomization.The Intervention group - neonates will receive tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hour after feeding twice daily along with Phototherapy, Control group - Phototherapy alone will be given along with conventional NICU care. Total serum bilirubin will be assessed as outcome measures daily once. Transcutaneous bilirubin will be assessed after every intervention.

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Detailed Description

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Conditions

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Neonatal Hyperbilirubinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

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.

Group Type EXPERIMENTAL

Massage therapy

Intervention Type OTHER

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.

Kinaesthetic stimulation

Intervention Type OTHER

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

Control Group

Neonates recruited in control group will receive phototherapy alone along with regular care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Massage therapy

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.

Intervention Type OTHER

Kinaesthetic stimulation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. New born in Neonatal Intensive Care Unit
2. Stable vitals
3. Full Term and Preterm neonates
4. Gestational age 34 weeks to 40 weeks
5. Birth weight -1800 - 3000 g
6. APGAR Score at birth of 8 -10
7. Total serum bilirubin levels \> 10 mg/dL

Minimum Eligible Age

24 Hours

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes