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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02815904
Other study ID # MMU/IEC/2016/751
Secondary ID U1111-1184-43242
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date May 2017

Study information

Verified date August 2018
Source Maharishi Markendeswar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date May 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Weeks
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Conventional handling
Positioning of preterm infants for optimal physiological development
Kinesthetic stimulation
For kinesthetic stimulation, all the limbs were given six passive flexion and extension movements
Kangaroo Mother Care
Providing skin to skin human touch

Locations

Country Name City State
India Preeti Parashar Ambala Haryana

Sponsors (2)

Lead Sponsor Collaborator
Asir John Samuel Maharishi Markandeshwar Institute of Medical Sciences and Research

Country where clinical trial is conducted

India, 

References & 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. — View Citation

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. — View Citation

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. Epub 2007 Oct 25. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;12:CD006275. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Heart rate Recorded pre and post intervention for each session up to 1 week
Secondary Respiratory rate Recorded pre and post intervention for each session up to 1 week
Secondary Systolic Blood Pressure Recorded pre and post intervention for each session up to 1 week
Secondary Saturation of inhaled oxygen Recorded pre and post intervention for each session up to 1 week
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