Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-29 @ 11:43 AM
Study NCT ID:
NCT06131606
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Stress Ball in Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'By drawing lots, the first set was chosen to correspond to the experimental group and the second set to correspond to the control group for the two groups.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This controlled randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': 'two weeks', 'description': 'This scale, which assesses the degree of pain, aims to make the patient express their pain in numbers. It starts with no pain (0) and goes up to unbearable pain (10 or 100). The high level of pain reporting is known as a disadvantage. Miró et al. found that the validity of the NRS for pain assessment was at an acceptable level (Miró et al., 2009). Hjermstad et al. compared the Visual Analog Scale (VAS), Numerical Rating Scale (NRS), and Verbal Descriptor Scale (VDS) for the assessment of pain intensity in adults and found that the NRS was more understandable and easier to use than the VAS and VDS'}], 'secondaryOutcomes': [{'measure': 'State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'two weeks', 'description': 'The scale was developed by Spielberger et al. Its reliability and validity in our country were performed by Öner and Le Compte. The scale consists of two subunits that measure anxiety separately, but in this study, the state-trait anxiety that patients feel indirectly from the stressful situation they are in will be used. A scale of 4-point Likert-type consisting of 20-item short statements measures the state-trait anxiety level of the individual.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Angiography', 'Anxiety', 'Nursing', 'Stress ball'], 'conditions': ['Pain, Acute']}, 'referencesModule': {'references': [{'pmid': '39742013', 'type': 'DERIVED', 'citation': 'Yuksel D, Gunes D. The Effect of Stress Ball on Anxiety and Pain Levels in Angiography: A Randomized Controlled Trial. Cardiovasc Ther. 2024 Aug 24;2024:5049092. doi: 10.1155/2024/5049092. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The target of this study was to determine the influence of stress ball application on pain and anxiety levels experienced by patients during angiography procedures.', 'detailedDescription': 'The purpose of this research was to investigate the effect of stress ball application, which is a non-pharmacologic method, on the pain and anxiety levels of patients during the angiography procedure. The present randomized controlled trial was conducted on all adult patients undergoing angiography between January 2023 and June 2023 in the Cardiovascular Surgery Clinic of a state hospital in eastern Turkey. The sample population was composed of 120 randomized patients who underwent stress ball application and received routine care. Numerical Rating Scale (NRS), Patient Information Form, and State-Trait Anxiety Inventory (STAI) were employed for data collection. The mean NRS posttest score of the experimental group patients increased significantly less than the control group (p\\<0.001), while the mean STAI posttest score decreased significantly (p= 0.019). A positive significant correlation was determined between the mean NRS and STAI post-test scores of the patients in the experimental group (p\\<0.05). It was found that the level of state-trait anxiety decreased as the pain decreased. The stress ball applied during angiography decreased the anxiety and pain levels of the patients. Stress ball application may be recommended as a complementary method to support pharmacologic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '47 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no communication problems,\n* being older than 18 years of age,\n* having good mental health,\n* undergoing wrist angiography (Radial Angiography),\n* being willing to take part in the study.\n\nExclusion Criteria:\n\n* Any complication during angiography.'}, 'identificationModule': {'nctId': 'NCT06131606', 'briefTitle': 'Effect of Stress Ball in Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Firat University'}, 'officialTitle': 'Effect of Stress Ball in Angiography: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FU-SN-DG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'During the angiography, the researcher asked the patient to squeeze the stress ball once for every count of three. The angiography procedure lasted approximately 25-30 minutes.', 'interventionNames': ['Behavioral: experimental group']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'No intervention other than the clinic protocol was applied to this group.'}], 'interventions': [{'name': 'experimental group', 'type': 'BEHAVIORAL', 'description': 'Patients in the experimental group were told how to use the stress ball before the procedure. The patient was then taken to the angiography unit. The stress ball was placed on the palms of the patients according to the procedure position. During the angiography, the researcher asked the patient to squeeze the stress ball once for every count of three. The angiography procedure lasted approximately 25-30 minutes. After the procedure, the NRS and STAI were filled out as a post-test 10 minutes after the patient was taken to the ward. The answers given by the patients were recorded by the researcher by marking them on the forms.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23119', 'city': 'Elâzığ', 'country': 'Turkey (Türkiye)', 'facility': 'Firat Universty', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dilek Güneş', 'investigatorAffiliation': 'Firat University'}}}}