Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-28 @ 7:08 AM
Study NCT ID:
NCT05784857
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2023-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Score', 'timeFrame': 'Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.', 'description': 'Pain will be evaluated using the Neonatal Pain Agitation and Sedation Scale (N-PASS).This scale was developed for preterm and term babies. The Turkish validity and reliability study was conducted in 2017. Crying, irritability, behavior-state, facial expression, extremity tone, and vital signs parameters are evaluated in the N-PASS scale. In this scale is evaluated with triple likert type and pain score can be between "0" and "10". Permission was obtained from the authors to use the scale.'}, {'measure': 'Change in Oxygen saturation', 'timeFrame': 'Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.', 'description': 'Oxygen saturation will be evaluated using the pulse oximeter'}, {'measure': 'Change in Heart rate', 'timeFrame': 'Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.', 'description': 'Heart rate will be evaluated using the monitor'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['touch', 'preterm infant', 'pain'], 'conditions': ['Preterm', 'Pain', 'Infant ALL']}, 'referencesModule': {'references': [{'pmid': '36137912', 'type': 'BACKGROUND', 'citation': 'Nist MD, Robinson A, Harrison TM, Pickler RH. An integrative review of clinician-administered comforting touch interventions and acute stress responses of preterm infants. J Pediatr Nurs. 2022 Nov-Dec;67:e113-e122. doi: 10.1016/j.pedn.2022.08.020. Epub 2022 Sep 20.'}, {'pmid': '32601011', 'type': 'BACKGROUND', 'citation': 'Dur S, Caglar S, Yildiz NU, Dogan P, Guney Varal I. The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing. Intensive Crit Care Nurs. 2020 Dec;61:102886. doi: 10.1016/j.iccn.2020.102886. Epub 2020 Jun 27.'}, {'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': '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."}]}, 'descriptionModule': {'briefSummary': "Recurrent and painful interventions such as heel lancing, venipuncture, dressing change, endotracheal aspiration are frequently performed in neonatal intensive care units (NICU). Touch is one of the infant's earliest developing senses. Therefore it is very important among individualized supportive care practices. Correct stimulation of the infant's sense of touch affects psychosocial development positively. In addition, it is reported that touch has a calming and analgesic effect during invasive interventions. Therefore, there is a need for touch appropriate for development of newborn.\n\nThe aim of this study was determine the effect of Yakson and Gentle Human Touch on pain and physiologic parameters in preterm infants during endotracheal aspiration.", 'detailedDescription': "It was designed as a prospective, quasi-experimental.In this study, each intubated infant will be followed up during 3 aspiration procedures. The first aspiration procedure will be performed without intervention. During the second and third aspiration procedure, yakson and gentle touch will be applied, respectively.Physiological parameters and pain score of newborn will be evaluated before, during and immediately after aspiration.\n\nYakson touch: Yakson touch is defined in traditional Korean culture as a kind of therapeutic touch that a mother believes will treat her sick child by stroking it with a compassionate, sincere and loving attitude. The Yakson protocol was developed by Im and Kim (2009) in an understandable form that can be easily implemented. While newborn is in supine position, practitioner applies Yakson touch. The Yakson touch method continue for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In this method, the palms of the practitioner and all fingers keep in close contact so that the babies don't feel pressure.\n\n1. Steady touch (5 minutes): One hand rest on the chest and abdomen of the preterm infant, while the other hand support the back and hip of the preterm infant.\n2. Compassionate Caress (5 minutes): In the same hand position, the practitioner repeat caressing and resting for 5 minutes: Caress (1 minutes), rest (30 seconds), caress (1 minutes), rest (30 seconds), and caress (2 minutes). The practitioner caress the infants' chest and belly with a 1 cm diameter clockwise circular movement every 10 second.\n3. Steady touch (5 minutes): The practitioner follow the steady touch procedure as previously describe.\n\nGentle Human Touch: Gentle human touch refers to steady contact of the skin without caressing or massaging. While the practitioner place one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was place on the lower abdomen covering the waist and hip of the infants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '24 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The gestational week of the infant is less than 38\n* Absence of congenital anomaly\n* Mechanical ventilator support\n* Absence of comorbid disease\n* Not having undergone surgery\n* No analgesic medication has been administered in the last hour\n\nExclusion Criteria:\n\n• Infants with diseases such as sepsis that interfere with the application of touch technique'}, 'identificationModule': {'nctId': 'NCT05784857', 'briefTitle': 'The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration', 'orgStudyIdInfo': {'id': 'ATADEK-2022/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'No Intervention and Touch Group', 'description': 'Each intubated infant will be follewed up during 3 aspiration procedures. Different touching techniques will be used for preterm infants in each aspiration application.\n\nThe first aspiration procedure will be performed without intervention. During the second aspiration procedure, yakson touch will be applied.Third aspiration procedure, gentle human touch will be applied.', 'interventionNames': ['Other: Touch Methods']}], 'interventions': [{'name': 'Touch Methods', 'type': 'OTHER', 'description': "The Yakson touch method continue for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In this method, the palms of the practitioner and all fingers keep in close contact so that the babies don't feel pressure.\n\nGentle human touch refers to steady contact of the skin without caressing or massaging. While the practitioner place one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was place on the lower abdomen covering the waist and hip of the infants.", 'armGroupLabels': ['No Intervention and Touch Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34750', 'city': 'Istanbul', 'state': 'Ataşehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Zehra Kan Öntürk, Assist Prof', 'role': 'CONTACT', 'email': 'zehra.kan@acibadem.edu.tr', 'phone': '02165004163'}, {'name': 'Zehra Kan Öntürk, Asist Prof', 'role': 'CONTACT', 'email': 'zehra.kan@acibadem.edu.tr', 'phone': '02165004163'}, {'name': 'İlçim Ercan, RN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Acibadem Health Group Ataşehir Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Zehra Kan Öntürk, Assist Prof', 'role': 'CONTACT', 'email': 'zehra.kan@acibadem.edu.tr', 'phone': '02165004163'}], 'overallOfficials': [{'name': 'Zehra Kan Öntürk, Assist Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acibadem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'Zehra Kan Onturk', 'investigatorAffiliation': 'Acibadem University'}}}}