Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-26 @ 10:50 PM
Study NCT ID:
NCT02815904
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk Neonates
Sponsor:
Asir John Samuel
Organization:
Study Overview
Official Title:
Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk neonates-a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YTKS
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: