Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-25 @ 9:12 PM
Study NCT ID:
NCT06562959
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2024-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Acupressure and Fluid Restriction Program on Salivary Flow and Fluid Adherence in Children on Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-18', 'studyFirstSubmitDate': '2024-08-18', 'studyFirstSubmitQcDate': '2024-08-18', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary Flow Visual Analogue Scale', 'timeFrame': 'After one month', 'description': "This tool used to evaluate the salivary flow assessment. It consisted of 8 validated items measuring two main dimensions of salivary flow. The first dimension assessing the impaired oral functions due to the sensation of dry mouth as indicated by having difficulty in swallowing or speaking. While the second dimension evaluating the dryness of oral mucosa (lips, mouth, tongue, or throat). Additionally, children were asked two global questions regarding salivary quantity and thirsty level. In each item, children's responses were rated on a 100-mm horizontal numeric scale ranged from No (0) to very dry (100)."}], 'secondaryOutcomes': [{'measure': 'Fluid Control in Hemodialysis Patients Scale', 'timeFrame': 'After one month', 'description': "This scale consisted of 24 items to evaluate the knowledge, behavior and attitude toward fluid restriction among patients undergoing hemodialysis. These items measure patients' compliance with fluid control."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupressure', 'Auricular', 'Fluid Control', 'Haemodialysis', 'Salivary Excretion', 'Therapeutic Adherence and Compliance'], 'conditions': ['Hemodialysis Complication']}, 'referencesModule': {'references': [{'pmid': '30720548', 'type': 'BACKGROUND', 'citation': 'Ozen N, Cinar FI, Askin D, Mut D, Turker T. Nonadherence in Hemodialysis Patients and Related Factors: A Multicenter Study. J Nurs Res. 2019 Aug;27(4):e36. doi: 10.1097/jnr.0000000000000309.'}, {'pmid': '25276744', 'type': 'BACKGROUND', 'citation': 'Ahrari S, Moshki M, Bahrami M. The Relationship Between Social Support and Adherence of Dietary and Fluids Restrictions among Hemodialysis Patients in Iran. J Caring Sci. 2014 Feb 27;3(1):11-9. doi: 10.5681/jcs.2014.002. eCollection 2014 Mar.'}, {'pmid': '29637052', 'type': 'BACKGROUND', 'citation': 'Beerendrakumar N, Ramamoorthy L, Haridasan S. Dietary and Fluid Regime Adherence in Chronic Kidney Disease Patients. J Caring Sci. 2018 Mar 1;7(1):17-20. doi: 10.15171/jcs.2018.003. eCollection 2018 Mar.'}, {'pmid': '36613157', 'type': 'BACKGROUND', 'citation': 'Dembowska E, Jaron A, Gabrysz-Trybek E, Bladowska J, Trybek G. Oral Mucosa Status in Patients with End-Stage Chronic Kidney Disease Undergoing Hemodialysis. Int J Environ Res Public Health. 2023 Jan 2;20(1):835. doi: 10.3390/ijerph20010835.'}, {'pmid': '29198641', 'type': 'BACKGROUND', 'citation': 'Griva K, Nandakumar M, Ng JH, Lam KFY, McBain H, Newman SP. Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis. Am J Kidney Dis. 2018 Mar;71(3):371-381. doi: 10.1053/j.ajkd.2017.09.014. Epub 2017 Dec 1.'}, {'pmid': '34639819', 'type': 'BACKGROUND', 'citation': 'Chang A, Chung Y, Kang M. Effects of the Combination of Auricular Acupressure and a Fluid-Restriction Adherence Program on Salivary Flow Rate, Xerostomia, Fluid Control, Interdialytic Weight Gain, and Diet-Related Quality of Life in Patients Undergoing Hemodialysis. Int J Environ Res Public Health. 2021 Oct 7;18(19):10520. doi: 10.3390/ijerph181910520.'}, {'pmid': '40597251', 'type': 'DERIVED', 'citation': 'Rashwan ZI, Abdellah MMM, Moursi F, Ismail EMAE. Effect of bundling auricular acupressure and fluid restriction program on salivary flow rate and fluid control adherence among children undergoing hemodialysis: a randomized control trial. BMC Nurs. 2025 Jul 1;24(1):796. doi: 10.1186/s12912-025-03433-x.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of auricular acupressure on salivary flow rate and fluid restriction adherence among children undergoing Hemodialysis .\n\nHypothesis Children undergoing Hemodialysis who receive both auricular acupressure and fluid restriction program exhibit better salivary flow rate and fluid control adherence than those who receive fluid restriction program only.', 'detailedDescription': "A non-randomized control trial was conducted at the Hemodialysis Unit in the Alexandria University Children's Hospital. A convenient sample of 60 children undergoing Hemodialysis was randomly assigned to two parallel groups. Both groups received the fluid restriction program in three types of sessions: general small-group discussion, individualized consultations, and follow-up. The study group also received auricular acupressure on four acupoints: Shenmen, Kidney Concha, Point Zero, and Upper Tragus."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ranged from 6 to 18 years\n* Receiving hemodialysis for at least one month\n\nExclusion Criteria:\n\n* Diabetes Mellitus\n* Heart Diseases\n* Autoimmune Disorders Such as Sjogren's Syndrome"}, 'identificationModule': {'nctId': 'NCT06562959', 'briefTitle': 'Auricular Acupressure and Fluid Restriction Program on Salivary Flow and Fluid Adherence in Children on Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Integrating Auricular Acupressure and Fluid Restriction Program on Salivary Flow Rate and Fluid Control Adherence Among Children Undergoing Haemodialysis', 'orgStudyIdInfo': {'id': 'AU-20-4-226-IRB00013620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The fluid restriction program included (a) General small-group discussion sessions, (b) individualized consultations, and (c) follow-up sessions.', 'interventionNames': ['Behavioral: Fluid Restriction Program']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'The intervention bundle, the fluid restriction program, and auricular acupressure were received at four appointments: Shenmen, Kidney Concha, Point Zero, and Upper Tragus.', 'interventionNames': ['Other: Intervention Bundle (Fluid Restriction Program and Auricular Acupressure']}], 'interventions': [{'name': 'Fluid Restriction Program', 'type': 'BEHAVIORAL', 'description': 'In order to design the fluid restriction program content (booklet). The fluid restriction program included (a) General small-group discussion sessions, (b) individualized consultations, and (c) follow-up sessions. In the group discussion sessions, children in both the study and control groups were divided into subgroups (6 participants per each). In the group discussion sessions, children in both the study and control groups were divided into subgroups. The sessions were conducted in the meeting room of the Hemodialysis unit lasts for 45 minutes. In the Individualized Consultations, children then were provided tailored, age-appropriate education. The researchers also arranged for regular follow-up for one months.', 'armGroupLabels': ['Control Group']}, {'name': 'Intervention Bundle (Fluid Restriction Program and Auricular Acupressure', 'type': 'OTHER', 'description': "the study group received the Fluid Restriction Program and Auricular Acupressure in four acupoints namely, Shenmen, Kidney Concha, Point Zero and Upper Tragus. The researcher's finger gently pressed on each determined acupoints in a circular movement with a clockwise direction for three minutes.", 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56321', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Nursing', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Eman Taha, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Profesor', 'investigatorFullName': 'Zohour Ibrahim Mahmoud Rashwan', 'investigatorAffiliation': 'Alexandria University'}}}}