Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk Neonates

NCT02815904 | Completed DMC

• 3 other identifiers: MMU/IEC/2016/751U1111-1184-43242016-002659-29
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The role of physiotherapy interventions in treatment of high risk infants has not been established even after a number of studies. The high risk infants are prone to developmental delays and early intervention is most effective for them owing to the plasticity of brain in early infancy. Yakson is one among the most effective and safe methods of tactile stimulation for preterm neonates. Tactile and kinesthetic stimulation techniques have been proved to be effective but there is no standardized protocol. The present study will try to investigate the efficacy of Yakson touch in combination with kinesthetic stimulation on the development of high risk neonates against conventional handling which will include developmental positioning and Kangaroo mother care.

Conditions

Preterm Infants; Infant, Low Birth Weight

Keywords

Neonates; physical therapy; neonatal intensive care units; yakson touch; kinesthetic stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Neonatal behavioral assessment scale (NBAS)

  Neonatal behavioral assessment scale (NBAS) will be used to monitor the effects of Yakson touch and kinesthetic stimulation on the development of high risk neonates. Baseline reading of NBAS will be recorded for the neonates in control and experimental groups before the beginning of intervention. The NBAS contains 28 behavioural items, 18 reflex items, and 7 supplementary items for fragile or high-risk infants. It is a neurobehavioural screening tool

  Change from Baseline Neonatal behavioral assessment scale at 1 week

Secondary Outcomes (4)

• Heart rate

  up to 1 week

• Respiratory rate

  up to 1 week

• Systolic Blood Pressure

  up to 1 week

• Saturation of inhaled oxygen

  up to 1 week

Study Arms (2)

Yakson touch and Kinesthetic stimulation

EXPERIMENTAL

Yakson touch (YT) The therapist will relax arms and shoulder muscles for 1 minute and will do deep breathing to accumulate Ki energy on the palms. The Therapist will apply Yakson on the neonate. Kinesthetic stimulation (KS) For giving kinesthetic stimulation the neonate will be placed in supine position. There will be six passive flexion and extension movements. Each of the movement will each last for approximately 10 seconds. The movements will be performed in the following order -right arm, left arm, right leg, left leg, both legs simultaneously

Other: Yakson touch; Other: Kinesthetic stimulation

Conventional Handling and KMC

ACTIVE COMPARATOR

Conventional Handling (CH) The neonates in control group will receive developmental positioning(positioning of preterm infants for optimal physiological development) for 20 minutes per hour for 5 days. Kangaroo mother care (KMC) Holding the neonate skin to skin by mother for one hour a day

Other: Conventional handling; Other: Kangaroo Mother Care

Interventions

Yakson touch OTHER

Yakson is a Korean therapeutic touch given to neonates and infants by caressing their abdomen with one hand while the other hand is placed on the back of the neonate\\infant to relieve their pain or to calm them down.

Also known as: YT

Yakson touch and Kinesthetic stimulation

Conventional handling OTHER

Positioning of preterm infants for optimal physiological development

Also known as: CH

Conventional Handling and KMC

Kinesthetic stimulation OTHER

For kinesthetic stimulation, all the limbs were given six passive flexion and extension movements

Also known as: KS

Yakson touch and Kinesthetic stimulation

Kangaroo Mother Care OTHER

Providing skin to skin human touch

Also known as: KMC

Conventional Handling and KMC

Eligibility Criteria

• Age: 1 Day - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with birth weight less than 2500 grams and born before 37 weeks of gestation males and females will be recruited in the study

You may not qualify if:

• Medically unstable neonates or neonates with communicable disease or congenital anomaly or skin infection will be excluded from the study

Sponsors & Collaborators

• Asir John Samuel: lead
• Maharishi Markendeswar University (Deemed to be University): collaborator

Study Sites (1)

Preeti Parashar

Ambāla, Haryana, 133207, India

Location

Related Publications (5)

• Bahman Bijari B, Iranmanesh S, Eshghi F, Baneshi MR. Gentle Human Touch and Yakson: The Effect on Preterm's Behavioral Reactions. ISRN Nurs. 2012;2012:750363. doi: 10.5402/2012/750363. Epub 2012 Jun 25.

  PMID: 22792482 BACKGROUND

• Pillai Riddell RR, Racine NM, Turcotte K, Uman LS, Horton RE, Din Osmun L, Ahola Kohut S, Hillgrove Stuart J, Stevens B, Gerwitz-Stern A. Non-pharmacological management of infant and young child procedural pain. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD006275. doi: 10.1002/14651858.CD006275.pub2.

  PMID: 21975752 BACKGROUND

• Im H, Kim E, Park E, Sung K, Oh W. Pain reduction of heel stick in neonates: Yakson compared to non-nutritive sucking. J Trop Pediatr. 2008 Feb;54(1):31-5. doi: 10.1093/tropej/fmm083. Epub 2007 Oct 25.

  PMID: 17962243 BACKGROUND

• Im H, Kim E. Effect of Yakson and Gentle Human Touch versus usual care on urine stress hormones and behaviors in preterm infants: a quasi-experimental study. Int J Nurs Stud. 2009 Apr;46(4):450-8. doi: 10.1016/j.ijnurstu.2008.01.009. Epub 2008 Mar 18.

  PMID: 18353332 BACKGROUND

• Im H, Kim E, Cain KC. Acute effects of Yakson and Gentle Human Touch on the behavioral state of preterm infants. J Child Health Care. 2009 Sep;13(3):212-26. doi: 10.1177/1367493509337441.

  PMID: 19713405 BACKGROUND

MeSH Terms

Interventions

Kangaroo-Mother Care Method

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Preeti Parashar, BPT

  Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Maharishi Markandeshwar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 28, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Published in, Journal of Nepal Paediatric Society
• Access Criteria: Full-text available free at the journal site

Locations

IN (1)