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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D060127', 'term': 'Kangaroo-Mother Care Method'}], 'ancestors': [{'id': 'D056888', 'term': 'Patient Positioning'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007224', 'term': 'Infant Care'}, {'id': 'D002654', 'term': 'Child Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Neonatal behavioral assessment scale (NBAS)', 'timeFrame': 'Change from Baseline Neonatal behavioral assessment scale at 1 week', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'up to 1 week', 'description': 'Recorded pre and post intervention for each session'}, {'measure': 'Respiratory rate', 'timeFrame': 'up to 1 week', 'description': 'Recorded pre and post intervention for each session'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'up to 1 week', 'description': 'Recorded pre and post intervention for each session'}, {'measure': 'Saturation of inhaled oxygen', 'timeFrame': 'up to 1 week', 'description': 'Recorded pre and post intervention for each session'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neonates', 'physical therapy', 'neonatal intensive care units', 'yakson touch', 'kinesthetic stimulation'], 'conditions': ['Preterm Infants', 'Infant, Low Birth Weight']}, 'referencesModule': {'references': [{'pmid': '22792482', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '21975752', 'type': 'BACKGROUND', '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.'}, {'pmid': '17962243', 'type': 'BACKGROUND', '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. doi: 10.1093/tropej/fmm083. Epub 2007 Oct 25.'}, {'pmid': '18353332', 'type': 'BACKGROUND', '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.'}, {'pmid': '19713405', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Yakson touch\n\n1. Universal precautions to maintain sterile conditions will be taken.\n2. 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.\n3. The therapist will relax arms and shoulder muscles for 1 minute and will do deep breathing to accumulate Ki energy on the palms.\n4. 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.\n5. 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.\n6. 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\n7. Resting the hands for 5 minutes- The therapist will rest the hands as previously described.\n\n(\\* 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.)\n\nKinesthetic 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\n\nControl 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Weeks', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates with birth weight less than 2500 grams and born before 37 weeks of gestation males and females will be recruited in the study\n\nExclusion Criteria:\n\n* Medically unstable neonates or neonates with communicable disease or congenital anomaly or skin infection will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT02815904', 'acronym': 'YTKS', 'briefTitle': 'Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi Markendeswar University (Deemed to be University)'}, 'officialTitle': 'Effects of Early Yakson Touch and Kinesthetic Stimulation on the Development of High Risk neonates-a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MMU/IEC/2016/751'}, 'secondaryIdInfos': [{'id': 'U1111-1184-4324', 'type': 'OTHER', 'domain': 'Universal Trial Number (UTN)'}, {'id': '2016-002659-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yakson touch and Kinesthetic stimulation', 'description': '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.\n\nKinesthetic 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', 'interventionNames': ['Other: Yakson touch', 'Other: Kinesthetic stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Handling and KMC', 'description': '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.\n\nKangaroo mother care (KMC) Holding the neonate skin to skin by mother for one hour a day', 'interventionNames': ['Other: Conventional handling', 'Other: Kangaroo Mother Care']}], 'interventions': [{'name': 'Yakson touch', 'type': 'OTHER', 'otherNames': ['YT'], 'description': '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.', 'armGroupLabels': ['Yakson touch and Kinesthetic stimulation']}, {'name': 'Conventional handling', 'type': 'OTHER', 'otherNames': ['CH'], 'description': 'Positioning of preterm infants for optimal physiological development', 'armGroupLabels': ['Conventional Handling and KMC']}, {'name': 'Kinesthetic stimulation', 'type': 'OTHER', 'otherNames': ['KS'], 'description': 'For kinesthetic stimulation, all the limbs were given six passive flexion and extension movements', 'armGroupLabels': ['Yakson touch and Kinesthetic stimulation']}, {'name': 'Kangaroo Mother Care', 'type': 'OTHER', 'otherNames': ['KMC'], 'description': 'Providing skin to skin human touch', 'armGroupLabels': ['Conventional Handling and KMC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133207', 'city': 'Ambāla', 'state': 'Haryana', 'country': 'India', 'facility': 'Preeti Parashar', 'geoPoint': {'lat': 30.36099, 'lon': 76.79782}}], 'overallOfficials': [{'name': 'Preeti Parashar, BPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Maharishi Markandeshwar University'}]}, 'ipdSharingStatementModule': {'url': 'http://dx.doi.org/10.3126/jnps.v37i2.16724', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Published in, Journal of Nepal Paediatric Society', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Full-text available free at the journal site'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asir John Samuel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maharishi Markendeswar University (Deemed to be University)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation', 'investigatorFullName': 'Asir John Samuel', 'investigatorAffiliation': 'Maharishi Markendeswar University (Deemed to be University)'}}}}