Preterm InfantsYTKSNCT02815904
Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk Neonates
A study testing Yakson touch, Conventional handling and Kinesthetic stimulation in people with Preterm Infants and Infant, Low Birth Weight, run by Asir John Samuel at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 1 day to 2 weeks
- Conditions the study is for
- Preterm Infants, Infant, Low Birth Weight
- What is being tested?
- Yakson touch, Conventional handling and Kinesthetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with birth weight less than 2500 grams and born before 37 weeks of gestation males and females will be recruited in the study
Who cannot join
- Medically unstable neonates or neonates with communicable disease or congenital anomaly or skin infection will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk neonates-a Randomized Controlled Trial
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.
Read the detailed description
Yakson touch
- Universal precautions to maintain sterile conditions will be taken.
- 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.
- 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. 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.
- 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.
- 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
- 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
- Preterm Infants, Infant, Low Birth Weight
- Being tested
- Yakson touch, Conventional handling, Kinesthetic stimulation, Kangaroo Mother Care
- Keywords
- Neonates, physical therapy, neonatal intensive care units, yakson touch, kinesthetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yakson touchOther
Also called YT
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 handlingOther
Also called CH
Positioning of preterm infants for optimal physiological development
Kinesthetic stimulationOther
Also called KS
For kinesthetic stimulation, all the limbs were given six passive flexion and extension movements
Kangaroo Mother CareOther
Also called KMC
Providing skin to skin human touch
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Conventional handling; Other: Kangaroo Mother Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline Neonatal behavioral assessment scale at 1 week
Secondary outcomes (4)
Heart rate
Recorded pre and post intervention for each session
Measured: up to 1 week
Respiratory rate
Recorded pre and post intervention for each session
Measured: up to 1 week
Systolic Blood Pressure
Recorded pre and post intervention for each session
Measured: up to 1 week
Saturation of inhaled oxygen
Recorded pre and post intervention for each session
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Preeti Parashar, BPT, Principal investigator, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Maharishi Markandeshwar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815904
- Sponsor's protocol ID
- MMU/IEC/2016/751
- Other IDs
- U1111-1184-4324, 2016-002659-29, 2016
- Acronym
- YTKS
- Status last verified
- Aug 2018
- First submitted
- 21 Jun 2016
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Parashar P, Samuel AJ, Aranha VP. Efficacy of early Yakson touch and kinaesthetic stimulation (YAKIN) on the development of high risk neonates: A randomized controlled trial protocol. J Nepal Paediatr Soc 2017;37(2):173-9.
Publications
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.
PubMed 22792482Pillai 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.
PubMed 21975752Im 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.
PubMed 17962243Im 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.
PubMed 18353332Im 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.
PubMed 19713405
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk neonates-a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02815904
- Acronym / sponsor ID
- YTKS / MMU/IEC/2016/751
- Conditions
- Preterm Infants, Infant, Low Birth Weight
- Keywords
- Neonates, physical therapy, neonatal intensive care units, yakson touch, kinesthetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Collaborators
- Maharishi Markendeswar University (Deemed to be University)
- Study start
- Aug 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Universal precautions to maintain sterile conditions will be taken.
- 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.
- 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. 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.
- 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.
- 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
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yakson touch and Kinesthetic stimulation | Experimental | Other: Yakson touch, Other: Kinesthetic stimulationYakson 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 |
| Conventional Handling and KMC | Active comparator | Other: Conventional handling, Other: Kangaroo Mother CareConventional 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 |
Who may qualify
- Ages
- 1 day to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates with birth weight less than 2500 grams and born before 37 weeks of gestation males and females will be recruited in the study
Key exclusion criteria (1 listed)
- Medically unstable neonates or neonates with communicable disease or congenital anomaly or skin infection will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yakson touchAlso: YTYakson 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. | Other | Yakson touch and Kinesthetic stimulation |
| Conventional handlingAlso: CHPositioning of preterm infants for optimal physiological development | Other | Conventional Handling and KMC |
| Kinesthetic stimulationAlso: KSFor kinesthetic stimulation, all the limbs were given six passive flexion and extension movements | Other | Yakson touch and Kinesthetic stimulation |
| Kangaroo Mother CareAlso: KMCProviding skin to skin human touch | Other | Conventional Handling and KMC |
Primary outcome
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
4 secondary outcomes
Heart rate
Time frame: up to 1 week
Respiratory rate
Time frame: up to 1 week
Systolic Blood Pressure
Time frame: up to 1 week
Saturation of inhaled oxygen
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Background: PubMed 22792482Bahman 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.
- Background: PubMed 21975752Pillai 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.
- Background: PubMed 17962243Im 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.
- Background: PubMed 18353332Im 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.
- Background: PubMed 19713405Im 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.
- Individual participant dataSharing planned: Yes. Parashar P, Samuel AJ, Aranha VP. Efficacy of early Yakson touch and kinaesthetic stimulation (YAKIN) on the development of high risk neonates: A randomized controlled trial protocol. J Nepal Paediatr Soc 2017;37(2):173-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preeti Parashar, BPT principal investigator
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Maharishi Markandeshwar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yakson touch, Conventional handling and Kinesthetic stimulation in people with Preterm Infants and Infant, Low Birth Weight, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neonatal behavioral assessment scale (NBAS) (time frame: Change from Baseline Neonatal behavioral assessment scale at 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02815904, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.