Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-04 @ 12:35 PM
Study NCT ID:
NCT06645457
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2024-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Stress Ball and 4-7-8 Breathing Technique on Fear, Anxiety and Physiological Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)', 'description': "Developed by Price et al. (1983), VAS is a reliable, valid and practical measurement tool for repeated measurements. The scale, which is generally used to score pain, will be used in this study to score patients' fear between 1-10 points. The scale is represented by a 10 cm line representing the lowest and highest scores for fear (0 = no fear, 10 = most intense fear)."}, {'measure': 'State-Trait Anxiety İnventory', 'timeFrame': 'At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)', 'description': 'It was developed by Spielberger and his colleagues in 1970. It has two parts: State and Trait Anxiety. The State Anxiety Scale section determines how a person feels at a particular moment and under certain conditions. The feelings or behaviors expressed by the person are answered by marking one of the options: (1) not at all, (2) a little, (3) a lot, (4) completely, depending on the degree of severity. Trait Anxiety Scale is related to how the individual feels in general, regardless of the current situation.'}], 'secondaryOutcomes': [{'measure': 'systolic blood pressure (mm/Hg)', 'timeFrame': 'At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)', 'description': 'Measurements are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).'}, {'measure': 'diastolic blood pressure (mm/Hg)', 'timeFrame': 'At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)', 'description': 'Measurement are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).'}, {'measure': 'SpO2-peripheral oxygen saturation (%)', 'timeFrame': 'At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)', 'description': 'Measurement are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).'}, {'measure': 'Respiratory rate (minute value)', 'timeFrame': 'At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)', 'description': 'Measurement are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).'}, {'measure': 'heart rate (minute value)', 'timeFrame': 'At the beginning and end of the 20-minute stress ball or breathing exercise intervention (before the endoscopy procedure)', 'description': 'Measurement are made at the beginning and end of the stress ball or breathing exercise intervention applied before the endoscopy (before the endoscopy procedure).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endoscopy', 'Breathing Exercises', 'Cognitive Therapy', 'Stress', 'Anxiety', 'Physiological Parameters']}, 'descriptionModule': {'briefSummary': "The study aimed to examine the effects of two different applications (stress ball and 4-7-8 breathing technique) before Upper GI Endoscopy on patients' fear, anxiety and physiological parameters before the procedure.\n\nThe study as a single-blind, pre-test and post-test experimental study.", 'detailedDescription': "Due to the procedures involved, endoscopy patients experience high levels of fear and anxiety. Fear and anxiety may activate the patient's autonomic nervous system, causing increased sweating, heart rate, blood pressure and respiratory rate, and complications related to the procedure. Reducing fear and anxiety and making the patient feel relaxed not only prevents possible harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to examine the effects of stress ball exercise and 4-7-8 breathing technique on the fear, anxiety and vital signs of patients who will undergo Upper Gastrointestinal (GI) endoscopy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Upper GI Endoscopy will be performed for the first time,\n2. American Society of Anesthesiologists (ASA) Status I-II\n3. Those over 18 years of age\n4. Participates in the research voluntarily and is willing to cooperate.\n5. No visual impairment, hearing impairment or communication problem,\n6. Not having a psychiatric diagnosis and not using anxiolytic, hypnotic or sedative drugs\n\nExclusion Criteria:\n\n1. Those diagnosed with severe respiratory failure\n2. Those who have health problems in the hand, wrist or arm area that prevent squeezing the stress ball.\n3. Using psychiatric medication (antipsychotic, antidepressant, anxiolytic, sedative, etc.\n4. Anyone who wishes to leave the research at any stage of the research, with his or her own initiative.'}, 'identificationModule': {'nctId': 'NCT06645457', 'briefTitle': 'The Effect of Stress Ball and 4-7-8 Breathing Technique on Fear, Anxiety and Physiological Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Kafkas University'}, 'officialTitle': 'The Effect of Stress Ball and 4-7-8 Breathing Technique on Pre-Procedure Fear, Anxiety and Physiological Parameters in Elderly Patients Undergoing Endoscopy: Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'KAU-SBF-AGP-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stress ball', 'description': 'group applying the stress ball for 20 minute before endoscopy', 'interventionNames': ['Other: stress ball']}, {'type': 'EXPERIMENTAL', 'label': '4-7-8 breathing technique', 'description': 'group applying the 4-7-8 breathing technique for 6 sets before endoscopy', 'interventionNames': ['Other: 4-7-8 breathing technique']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The group in which no intervention was performed before endoscopy and routine care was given'}], 'interventions': [{'name': 'stress ball', 'type': 'OTHER', 'description': 'Patients squeeze the stress ball', 'armGroupLabels': ['stress ball']}, {'name': '4-7-8 breathing technique', 'type': 'OTHER', 'description': 'breathing in quietly through the nose for 4 seconds. holding the breath for a count of 7 seconds. exhaling forcefully through the mouth for 8 seconds.', 'armGroupLabels': ['4-7-8 breathing technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Mehtap ÇULLU', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'Ayşe Gül Parlak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kafkas Üniversity'}, {'name': 'Mehtap Çullu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Muğla Üniversity'}, {'name': 'Zeliha Özkaraca, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'muğla provincial directorate of national education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafkas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ayse Gul Parlak', 'investigatorAffiliation': 'Kafkas University'}}}}