Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

Not Applicable

Completed

• Conditions: Neonatal Hyperbilirubinemia
• Interventions: Other: Massage therapy; Other: Kinaesthetic stimulation

• Registration Number: NCT05077787
• Lead Sponsor: Asir John Samuel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-14
• Study Start: 2022-04-01
• Status Verified: 2024-01
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Kinaesthetic stimulation	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.
Experimental Group	Massage therapy	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.

Primary Outcome Measures

Name	Time	Method
Total Serum Bilirubin (TSB)	Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention	It 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 intervention	Transcutaneous Bilirubin will measure neonatal jaundice.
Weight Gain	Changes in the weight will be measured at baseline and at the end of three days intervention	Weight gain will evaluate the change in neonatal weight

Trial Locations

Locations (1)

Civil Hospital; 🇮🇳 Ropar, Punjab, India