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Clinical Trials/NCT02815904
NCT02815904CompletedNot Applicable

Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk neonates-a Randomized Controlled Trial

Asir John Samuel2 sites in 1 country28 target enrollmentStarted: August 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
28
Locations
2
Primary Endpoint
Change in Neonatal behavioral assessment scale (NBAS)

Study Overview

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.

Detailed Description

Yakson touch

  1. Universal precautions to maintain sterile conditions will be taken.
  2. Then the therapist will warm both hands with a radiant warmer so that the temperature of the palms reaches between 93F and 94F (33.9-34.4°C). Digital thermometer will be used to check the temperature of palms.
  3. The therapist will relax arms and shoulder muscles for 1 minute and will do deep breathing to accumulate Ki energy on the palms.
  4. The Therapist will apply Yakson on the neonate. Yakson will be given for 15 minutes which will be divided into resting the hands, caressing gently, and again resting the hands, each of which will last for 5 minutes. Throughout the application of Yakson, fingers and palm of the therapist will be in constant contact and the contact will be such that there is no pressure on the infant.
  5. Resting the hands for 5 minutes- While one hand is resting on the chest and abdomen of the neonate and other hand is supporting the back, the therapist will concentrate on resting hands assuming that a healthy Ki energy is passing to the neonate. During this therapist will do slow breathing to remain relaxed.
  6. Caressing gently for 5 minutes-With hand in same position, the therapist will caress repeatedly for 5 minutes. Therapist will caress for 1 minute, rest for 30 seconds, caress for 1 minute, rest for 30 seconds and caress for 2 minutes. The therapist will caress the abdomen and chest of the infant in clockwise direction in a diameter of 1 centimeter in circular motion every 10 seconds
  7. Resting the hands for 5 minutes- The therapist will rest the hands as previously described.

(* The therapist will caress repeatedly for 5 minutes. Therapist will caress for 1 minute, rest for 30 seconds, caress for 1 minute, rest for 30 seconds and caress for 2 minutes. The therapist will caress the abdomen and chest of the infant in clockwise direction in a diameter of 1 centimeter in circular motion every 10 seconds.)

Kinesthetic stimulation For giving kinesthetic stimulation the infant 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

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
1 Day to 2 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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

Intervention: Yakson touch (Other)

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

Intervention: Kinesthetic stimulation (Other)

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

Intervention: Conventional handling (Other)

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

Intervention: Kangaroo Mother Care (Other)

Outcomes

Primary Outcomes

Change in Neonatal behavioral assessment scale (NBAS)

Time Frame: Change from Baseline Neonatal behavioral assessment scale at 1 week

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

Secondary Outcomes

  • Respiratory rate(up to 1 week)
  • Systolic Blood Pressure(up to 1 week)
  • Heart rate(up to 1 week)
  • Saturation of inhaled oxygen(up to 1 week)

Investigators

Sponsor
Asir John Samuel
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Asir John Samuel

Assistant Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Maharishi Markendeswar University (Deemed to be University)

Study Sites (2)

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