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Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

A

Asir John Samuel

Status

Completed

Conditions

Neonatal Hyperbilirubinemia

Treatments

Other: Massage therapy
Other: Kinaesthetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05077787
U1111-1269-9921

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

24 hours to 10 days old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 2 patient groups

Experimental Group
Experimental group
Description:
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.
Treatment:
Other: Kinaesthetic stimulation
Other: Massage therapy
Control Group
No Intervention group
Description:
Neonates recruited in control group will receive phototherapy alone along with regular care

Trial contacts and locations

1

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Central trial contact

Asir John Samuel, PhD; Saumya Kothiyal, PhD scholar

Data sourced from clinicaltrials.gov

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