Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-02 @ 7:26 AM
Study NCT ID:
NCT06436404
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2024-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hammock Position and Kangaroo Care
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single blinding (Participant)'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled, single-blind parallel design experimental study.In the study, premature infants will be divided into three groups by randomization.\n\nEach group will be referred to as A, B or C for convenience.\n\nThe type of intervention will be determined by drawing lots for A, B and C.\n\nFor example, A= Hammock Position, B= Kangaroo Care c=Control Group.\n\nWhen applying the hammock position to a group; The other group will receive kangaroo care, while the other group will receive standard care.\n\nFor randomization, blocks of 3 created for 42 infants and this process done by an independent statistician.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determining the descriptive characteristics of babies', 'timeFrame': '1 hour', 'description': '1- Infant Introductory Form: The form includes introductory information about the baby (Postnatal day, gestational age, birth weight (g), weight on the day of the intervention, type of birth, gender, postnatal age, physiological weight loss, feeding style, 1st and 5th minute Apgar score, maternal age. It consists of questions containing).'}, {'measure': 'Hammock position and Kangaroo care increase comfort level in preterm infants', 'timeFrame': '1 hour', 'description': '2- The COMFORT-behavior scale (COMFORTneo): It is a Likert-type scale developed to be used in evaluating the sedation and comfort needs, pain and distress of newborns monitored in intensive care. The scale was revised for newborns. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.'}, {'measure': 'Hammock position and Kangaroo care decrease pain and stress level in preterm infants', 'timeFrame': '1 hour', 'description': '3- ALPS-Neo "Newborn Pain and Stress Assessment Scale": The scale was developed in 2014 to evaluate pain and stress in premature and term newborns. Measurement is made through observation. As the score obtained increases, stress and pain increase.'}], 'secondaryOutcomes': [{'measure': 'Hammock position and Kangaroo care support physiological stability in premature infants.', 'timeFrame': '1 hour', 'description': '1- Physiological Parameter Tracking Chart The follow-up chart prepared by the researcher is a form in which physiological parameters such as heart rate (min), oxygen saturation (%SpO2), body temperature (°C), respiratory rate (min) are recorded. Measurements will be taken 3 times in total: before, during and after the hammock position and kangaroo care application. A monitor device used in clinical routine will be used to measure physiological parameters.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premature', 'Pain', 'Stress', 'Comfort'], 'conditions': ['Infant Development', 'Premature']}, 'referencesModule': {'references': [{'pmid': '7703730', 'type': 'BACKGROUND', 'citation': 'Indyk HE, Woollard DC. Enzymatic determination of free carnitine in milk and infant formulas. J AOAC Int. 1995 Jan-Feb;78(1):69-74.'}, {'pmid': '31851240', 'type': 'BACKGROUND', 'citation': 'Costa KSF, Fernandes DDS, Paula RAP, Guarda LEDA, Dare MF, Castral TC, Ribeiro LM. Hammock and nesting in preterm infants: randomized controlled trial. Rev Bras Enferm. 2019 Dec;72(suppl 3):96-102. doi: 10.1590/0034-7167-2018-0099. English, Portuguese.'}, {'pmid': '23651076', 'type': 'BACKGROUND', 'citation': 'Gerull R, Cignacco E, Stoffel L, Sellam G, Nelle M. Physiological parameters after nonpharmacological analgesia in preterm infants: a randomized trial. Acta Paediatr. 2013 Aug;102(8):e368-73. doi: 10.1111/apa.12288. Epub 2013 May 28.'}, {'pmid': '15136961', 'type': 'BACKGROUND', 'citation': 'Huang CM, Tung WS, Kuo LL, Ying-Ju C. Comparison of pain responses of premature infants to the heelstick between containment and swaddling. J Nurs Res. 2004 Mar;12(1):31-40. doi: 10.1097/01.jnr.0000387486.78685.c5.'}, {'pmid': '2959889', 'type': 'BACKGROUND', 'citation': 'Schwendener RA, Schott H, Hartmann HR, Supersaxo A, Rubas W, Hengartner H. [Liposomes as carriers of lipophilic cytosine arabinoside and fluorodeoxyuridine derivatives. Their cytostatic effect and possibilities of tumor cell specific therapy]. Onkologie. 1987 Aug;10(4):232-9. doi: 10.1159/000216411. German.'}]}, 'descriptionModule': {'briefSummary': 'This study was planned to evaluate the effectiveness of two positions that may have an effect on pain, stress, comfort and physiological parameters in premature infants.', 'detailedDescription': 'Providing adequate therapeutic positioning in preterms can minimize postural abnormalities and asymmetries associated with prematurity and NICU stay, as well as support the development of spontaneous and functional motor abilities of infants. Studies show that positioning directly affects cardiovascular, respiratory and sleep-wake states. When the literature is examined; Although the vital signs, pain levels and comfort levels of babies in the NICU have been examined in many applications, the number of studies comparing the hammock position and Kangaroo care in preterms is very limited. Therefore, this study will try to determine the effect of hammock position and kangaroo care on the pain, stress, comfort and physiological parameters of the infants. It is thought that the study will provide new data to the literature and lead to many researches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '32 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants having at least 2 days of inpatient treatment from,\n* Infants 32-36+6. being born during the gestational week,\n* Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),\n* Apgar score above 6 at the 5th minute Infants will included.\n\nExclusion Criteria:\n\n* Infants having at least 2 days of inpatient treatment from,\n* Infants 32-36+6. being born during the gestational week,\n* Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),\n* Apgar score above 6 at the 5th minute Infants will included.'}, 'identificationModule': {'nctId': 'NCT06436404', 'briefTitle': 'Hammock Position and Kangaroo Care', 'organization': {'class': 'OTHER', 'fullName': 'Nigde Omer Halisdemir University'}, 'officialTitle': 'Effect of Two Different Positions on Pain, Stress, Comfort and Physiological Parameters of the Premature Infants: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'He2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hammock position group', 'description': 'A hammock inside the incubator, developed by researchers to prevent heat loss and support posture, will be used.', 'interventionNames': ['Other: Hammock intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Kangaroo care group', 'description': 'Kangaroo care will be applied to these preterm infants.', 'interventionNames': ['Other: Kangaroo care intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Contol group', 'description': 'The group will not receive any other intervention.'}], 'interventions': [{'name': 'Hammock intervention', 'type': 'OTHER', 'description': 'It is a hammock made of 100% cotton fabric that prevents heat loss and has an internal apparatus to support the position, which can be adapted to the incubator by the researchers.', 'armGroupLabels': ['Hammock position group']}, {'name': 'Kangaroo care intervention', 'type': 'OTHER', 'description': 'In the clinic, the baby will receive kangaroo care with his mother in a quiet room with reduced lighting.', 'armGroupLabels': ['Kangaroo care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51000', 'city': 'Niğde', 'state': 'Center', 'country': 'Turkey (Türkiye)', 'facility': 'Niğde Ömer Halisdemir University', 'geoPoint': {'lat': 37.96583, 'lon': 34.67935}}], 'overallOfficials': [{'name': 'Sibel KUCUKOGLU, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Selcuk University'}, {'name': 'Halil DEGIRMENCIOGLU, Md.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nigde Omer Halisdemir University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It will be shared after the article is published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nigde Omer Halisdemir University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Selcuk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}