Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-26 @ 2:53 AM
Study NCT ID:
NCT06437366
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse-Led Heart Math Training Program With Substance Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-25', 'studyFirstSubmitDate': '2024-05-25', 'studyFirstSubmitQcDate': '2024-05-25', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients with substance use disorder who participate in a nurse-led HeartMath training program', 'timeFrame': 'three months', 'description': 'Patients with substance use disorder who participate in a nurse-led HeartMath training program will show a statistically significant increase in resilience, as measured by the Connor-Davidson Resilience Scale (CD-RISC), compared to those who do not participate in the program.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Abuse']}, 'referencesModule': {'references': [{'pmid': '40708166', 'type': 'DERIVED', 'citation': 'Elzohairy NW, Eweida RS, Othman AA, Hammad HA, Ramadan Atta MH. Effectiveness of a Nurse-Led HeartMath Training Program on Resilience, Emotional Adjustment, and Treatment Motivation Among Patients With Substance Use Disorder: A Randomized Control Trial. Worldviews Evid Based Nurs. 2025 Aug;22(4):e70061. doi: 10.1111/wvn.70061.'}]}, 'descriptionModule': {'briefSummary': "Substance use disorders (SUDs) pose significant challenges to individuals' psychological well-being, resilience, and emotional adjustment. These disorders often lead to detrimental effects on physical health, mental health, and overall quality of life, creating a critical need for effective interventions that can support recovery and enhance emotional resilience. One promising approach is the implementation of nurse-led HeartMath training programs. These programs utilize evidence-based techniques to improve emotional regulation, increase resilience, and foster a sense of coherence, which is the ability to perceive life as comprehensible, manageable, and meaningful.", 'detailedDescription': 'The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population.\n\nBrief About the Training Program\n\nThe nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment:\n\nHeart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence.\n\nEmotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress.\n\nBiofeedback Technology: Participants use HeartMath biofeedback devices that provide real-time feedback on their heart rhythm patterns, enabling them to monitor and improve their coherence levels.\n\nResilience-Building Exercises: The program incorporates activities and practices aimed at enhancing personal resilience, such as positive visualization and the cultivation of gratitude and appreciation.\n\nIndividual and Group Sessions: The training is delivered through a combination of individual coaching and group workshops, providing both personalized support and a sense of community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* substance abuse for at least one month\n\nExclusion Criteria:\n\n* out side hospital'}, 'identificationModule': {'nctId': 'NCT06437366', 'acronym': 'HeartMathsub', 'briefTitle': 'Nurse-Led Heart Math Training Program With Substance Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effectiveness of a Nurse-Led Heart Math Training Program on Resilience , Sense of Coherence, and Emotional Adjustment in Patients With Substance Use Disorder', 'orgStudyIdInfo': {'id': '100.a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nurse-led HeartMath training program on patients with substance use disorder', 'description': 'The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population.', 'interventionNames': ['Behavioral: Nurse-Led Heart Math Training Program']}, {'type': 'NO_INTERVENTION', 'label': 'Non-experimental patients with substance use disorder'}], 'interventions': [{'name': 'Nurse-Led Heart Math Training Program', 'type': 'BEHAVIORAL', 'description': 'he nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment:\n\nHeart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence.\n\nEmotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress.', 'armGroupLabels': ['nurse-led HeartMath training program on patients with substance use disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21913', 'city': 'Alexandria', 'state': 'Alexandria Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mohamed H atta', 'role': 'CONTACT', 'email': 'mohamed-hussein@alexu.edu.com', 'phone': '2026609088'}], 'facility': 'Alexandria university', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}