Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia

NCT05077787 | Completed DMC

• 1 other identifier: U1111-1269-9921
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hyperbilirubinemia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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; Other: Kinaesthetic stimulation

Control Group

NO INTERVENTION

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

Interventions

Massage therapy 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.

Experimental Group

Kinaesthetic stimulation 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

Experimental Group

Eligibility Criteria

• Age: 24 Hours - 10 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Asir John Samuel: lead

Study Sites (1)

Civil Hospital

Ropar, Punjab, 140001, India

Location

Related Publications (4)

• 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.

  PMID: 33014346 BACKGROUND

• 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.

  PMID: 26607061 BACKGROUND

• Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.

  PMID: 31174382 BACKGROUND

• Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.

  PMID: 28368368 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Massage

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Saumya Kothiyal, MPT

  Maharishi Markendeshawar (Deemed to be University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: April 1, 2022
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)