Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-10 @ 9:49 PM
Study NCT ID:
NCT05180058
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2021-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol with Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2021-12-17', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'heart rate', 'timeFrame': '5 minutes', 'description': 'heart rate before, during and after the procedure (1st and 2nd min.)'}, {'measure': 'oxygen saturation values', 'timeFrame': '5 minutes', 'description': 'oxygen saturation values before, during and after the procedure (1st and 2nd min.)'}, {'measure': 'PIPP Scale', 'timeFrame': '5 minutes', 'description': 'pain scores before, during and after the procedure (1st and 2nd min.)'}, {'measure': 'comfort scale score', 'timeFrame': '5 minutes', 'description': 'comfort scores before, during and after the procedure (1st and 2nd min.)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premature', 'orogastric tube', 'oral sucrose', 'Wrapping'], 'conditions': ['Premature', 'Orogastric Tube', 'Oral Sucrose']}, 'referencesModule': {'references': [{'pmid': '39075946', 'type': 'DERIVED', 'citation': 'Apaydin Cirik V, Turkmen AS, Derin E, Yilmaz N. Effectiveness of an atraumatic orogastric tube insertion protocol for the combined use of swaddling, facilitated tucking, breast milk and sucrose. Int J Nurs Pract. 2024 Dec;30(6):e13293. doi: 10.1111/ijn.13293. Epub 2024 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to reduce the pain and increase comfort during the orogastric tube insertion (OGT) procedure, which is routinely applied to feed these babies at 32-34 weeks of age, in preterm newborns with a sucking reflex.In addition, this study also aimed to develop an atraumatic OGT attachment protocol by combining wrapping, fetal position, breast milk and oral sucrose combined therapy.\n\nIt was planned as a randomized double-blind and controlled experimental study to evaluate the efficacy of using In addition, this study also planned to develop the atraumatic OGT insertion procedure through combined therapy of wrapping, fetal position, breast milk, and oral sucrose. The population of the research consists of preterm babies who are treated in the Neonatal Intensive Care Unit of Selcuk University Hospital. Babies to be sampled are preterm babies who are between 32 and 34 weeks of gestation.\n\nPreterm newborns will be randomly divided into five groups;\n\n* Group 1: Control\n* Group 2: Wrapping + breast milk (2 ml)\n* Group 3: Wrapping + oral sucrose (0.2 ml/kg 20% sucrose)\n* Group 4: Fetal position + breast milk (2 ml)\n* Group 5: Fetal position + oral sucrose (0.2 ml/kg 20% sucrose) In the NICU, OGT insertion will be performed by the clinical nurse as part of the treatment for preterm newborns, which the clinic physician deems necessary. The clinical nurse and clinician will be responsible for OGT insertion in preterm newborns. In this study, only wrapping, fetal positioning, oral breast milk and sucrose delivery methods will be applied to preterm newborns by the researcher. In this context, the responsibility of the researcher in the study will be to apply non-pharmacological methods to preterm newborns only before OGT insertion and to evaluate the pain symptoms in preterm newborns during and after OGT insertion.\n\nThe obtained data will be evaluated in SPSS-21 package program in computer environment. Normality tests, chi-square, t test, Anova, and advanced analysis will be used when necessary in the analysis of the data. The relationship between the mean score of the scale and other variables will be evaluated by correlation regression analysis. Significance will be accepted as p\\<0.05.', 'detailedDescription': 'Ethical and institutional permissions were obtained before starting to collect the data. Written consent will be obtained from all parents via a voluntary consent form. Preterm newborns will be randomly selected into 5 groups.\n\n* Group 1 (Control Group); Wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal position+breastmilk methods were not applied to preterms in the routine care group. However, in order to be an ethical practice and to provide ethical standard care intervention, verbal relaxation and soft touch applications were applied by the researcher in the procedure.\n* Group 2 (Wrapping + Breastmilk Group); Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by the researcher with a sterile syringe 2 minutes before the OGT insertion to the same newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.\n* Group 3 (Wrapping + Oral Sucrose Group); Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given to the same newborn by the researcher with a sterile syringe 2 minutes before OGT insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn on the upper part of the tongue through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at 1 minute before the procedure, during and after the procedure at 1 minute and 2 minutes (4 measurements).\n* Group 4 (Fetal Position + Breastmilk Group); The fetal position will be given to the preterm newborn immediately after 2 ml of breast milk is given by the researcher 3 minutes before OGT insertion. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.\n* Group 5 (Fetal Position + Oral Sucrose Group); The fetal position will be given to the preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3 minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the preterm newborn on the upper part of the tongue by means of an injector. At the end of the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure.\n\nNewborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.\n\nHypotheses (H1) There is a significant difference between the methods applied in the OGT insertion procedure (wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal position+breastmilk) in terms of heart rate in preterms.\n\nThere is a significant difference between the methods applied in the (H2) OGT insertion procedure in terms of oxygen saturation of preterms.\n\n(H3) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the estimated pain score of preterms.\n\n(H4) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the estimated distress score of preterms.\n\n(H5) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the comfort level of preterms.\n\n(H6) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the mean of preterm pain in preterms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Day', 'genderBased': True, 'genderDescription': 'premature newborns who gestational week is between 32 and 34 weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational week is between 32 and 34 weeks\n* Having breast milk\n* Stable health status\n* Spontaneous breathing\n* Being fed by an orogastric tube\n* Not being exposed to a painful procedure at least half an hour before the interventions\n* Not taking opioid or non-opioid analgesics\n\nExclusion Criteria:\n\n* newborns who did not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05180058', 'acronym': 'OGT', 'briefTitle': 'Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol with Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose', 'organization': {'class': 'OTHER', 'fullName': 'Karamanoğlu Mehmetbey University'}, 'officialTitle': 'Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol with Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose', 'orgStudyIdInfo': {'id': 'oral nasogastric tube'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wrapping + Breastmilk Group', 'description': 'Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by the researcher with a sterile syringe 2 minutes before the OGT insertion to the same newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.', 'interventionNames': ['Other: Wrapping + Breastmilk Group']}, {'type': 'EXPERIMENTAL', 'label': 'Wrapping + Oral Sucrose Group', 'description': 'Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given to the same newborn by the researcher with a sterile syringe 2 minutes before OGT insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn on the upper part of the tongue through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at 1 minute before the procedure, during and after the procedure at 1 minute and 2 minutes (4 measurements).', 'interventionNames': ['Other: Wrapping + Breastmilk Group']}, {'type': 'EXPERIMENTAL', 'label': 'Fetal Position + Breastmilk Group', 'description': 'The fetal position will be given to the preterm newborn immediately after 2 ml of breast milk is given by the researcher 3 minutes before OGT insertion. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.', 'interventionNames': ['Other: Wrapping + Breastmilk Group']}, {'type': 'EXPERIMENTAL', 'label': 'Fetal Position + Oral Sucrose Group', 'description': 'The fetal position will be given to the preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3 minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the preterm newborn on the upper part of the tongue by means of an injector. At the end of the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure.', 'interventionNames': ['Other: Wrapping + Breastmilk Group']}], 'interventions': [{'name': 'Wrapping + Breastmilk Group', 'type': 'OTHER', 'otherNames': ['Wrapping + Oral Sucrose Group', 'Fetal Position + Breastmilk Group', 'Fetal Position + Oral Sucrose Group'], 'description': 'Interventions applied during orogastric tube insertion', 'armGroupLabels': ['Fetal Position + Breastmilk Group', 'Fetal Position + Oral Sucrose Group', 'Wrapping + Breastmilk Group', 'Wrapping + Oral Sucrose Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70100', 'city': 'Karaman', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'KaramanogluMehmetbeyU', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}, {'city': 'Karaman', 'country': 'Turkey (Türkiye)', 'facility': 'Karamanoglu Mehmetbey University', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ayse Sonay Turkmen, Prof.Dr', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.', 'investigatorFullName': 'Ayse Sonay Turkmen, Prof.Dr', 'investigatorAffiliation': 'Karamanoğlu Mehmetbey University'}}}}