Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Hyperbilirubinemia
• Intervention / Treatment: Other: Massage therapy; Other: Kinaesthetic stimulation

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saumya Kothiyal, PhD scholar; Phone Number: 8650987709; Email: saumyakothiyal28@gmail.com
• Study Contact Backup: Name: Asir John Samuel, PhD; Phone Number: 8059930222; Email: asirjohnsamuel@mmumullana.org

Study Locations

• India
  • Punjab
    • Ropar, Punjab, India, 140001
      • Civil Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 days (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; 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
No Intervention: Control Group; Neonates recruited in control group will receive phototherapy alone along with regular care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Asir John Samuel
• Investigators: Principal Investigator: Saumya Kothiyal, MPT, Maharishi Markendeshawar (Deemed to be University)

Publications and helpful links

General Publications

• Rahmawati D, Sampurna MTA, Etika R, Utomo MT, Bos AF. Transcutaneous bilirubin level to predict hyperbilirubinemia in preterm neonates. F1000Res. 2020 Apr 28;9:300. doi: 10.12688/f1000research.22264.2. eCollection 2020.
• Lin CH, Yang HC, Cheng CS, Yen CE. Effects of infant massage on jaundiced neonates undergoing phototherapy. Ital J Pediatr. 2015 Nov 25;41:94. doi: 10.1186/s13052-015-0202-y.
• Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.
• Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: U1111-1269-9921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No