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Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05077787
Enrollment
68
Registered
2021-10-14
Start date
2022-04-01
Completion date
2024-01-11
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hyperbilirubinemia

Brief summary

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.

Interventions

OTHERMassage 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.

OTHERKinaesthetic 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

Sponsors

Asir John Samuel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 10 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total Serum Bilirubin (TSB)Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days interventionIt will measure total bilirubin level in blood of neonates
Transcutaneous Bilirubin (TcB)Changes in the Transcutaneous Bilirubin level will be measured daily for three days before and after interventionTranscutaneous Bilirubin will measure neonatal jaundice.
Weight GainChanges in the weight will be measured at baseline and at the end of three days interventionWeight gain will evaluate the change in neonatal weight

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026