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

NCT ID: NCT02815904

Last Updated: 2018-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Preterm Infants Infant, Low Birth Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Yakson touch and Kinesthetic stimulation

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

Group Type EXPERIMENTAL

Yakson touch

Intervention Type 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.

Kinesthetic stimulation

Intervention Type OTHER

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

Conventional Handling and KMC

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

Group Type ACTIVE_COMPARATOR

Conventional handling

Intervention Type OTHER

Positioning of preterm infants for optimal physiological development

Kangaroo Mother Care

Intervention Type OTHER

Providing skin to skin human touch

Interventions

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Yakson touch

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.

Intervention Type OTHER

Conventional handling

Positioning of preterm infants for optimal physiological development

Intervention Type OTHER

Kinesthetic stimulation

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

Intervention Type OTHER

Kangaroo Mother Care

Providing skin to skin human touch

Intervention Type OTHER

Other Intervention Names

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YT CH KS KMC

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role collaborator

Asir John Samuel

OTHER

Sponsor Role lead

Responsible Party

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Asir John Samuel

Assistant Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Preeti Parashar, BPT

Role: PRINCIPAL_INVESTIGATOR

Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Maharishi Markandeshwar University

Locations

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Preeti Parashar

Ambāla, Haryana, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 22792482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21975752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17962243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18353332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19713405 (View on PubMed)

Other Identifiers

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U1111-1184-4324

Identifier Type: OTHER

Identifier Source: secondary_id

2016-002659-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MMU/IEC/2016/751

Identifier Type: -

Identifier Source: org_study_id

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