Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-31 @ 3:12 PM
Study NCT ID:
NCT05359458
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Freedom Liberation Technique, Surgical Fear and Anxiety
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Fear Scale', 'timeFrame': 'through study completion, an average of 5 month', 'description': 'Surgical Fear Scale will be filled in the preoperative period. ll items are scored on an eleven point numeric rating scale (NRS) ranging from 0 (not at all afraid) to 10 (very afraid). This results in a score of 0-40 for each subscale and a total score of 0 to 80.'}], 'secondaryOutcomes': [{'measure': 'Anxiety Scale', 'timeFrame': 'through study completion, an average of 5 month', 'description': 'Anxiety scale will be filled in the preoperative period. The scale consists of 10 statements that include the fears that patients may experience about the surgery. The maximum score that can be obtained from the scale is 50. High scores in scale scoring reflect concerns about pain, death during surgery, and postoperative complications and limitations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'anxiety'], 'conditions': ['Emotional Distress']}, 'descriptionModule': {'briefSummary': 'Aim: In this study, the effect of Emotional Freedom Technique applied to patients before Laparoscopic Cholecystectomy on surgical fear and anxiety was investigated.\n\nDesign: This is a randomized controlled study. Method: A total of 112 patients who were going to have Laparoscopic Cholecystectomy were randomly divided into two groups each including 56 participants. The intervention group was provided with Emotional Freedom Technique. The control group received routine face-to-face education. Surgical fear and anxiety were examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical treatment for Laparoscopic Cholecystectomy\n* 18 years of age or older\n* Mentally healthy\n\nExclusion Criteria:\n\n* Agree to participate in the study'}, 'identificationModule': {'nctId': 'NCT05359458', 'briefTitle': 'Emotional Freedom Liberation Technique, Surgical Fear and Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect of Emotional Freedom Liberation Technique on Surgical Fear and Anxiety Applied to Patients Before Laparoscopic Cholecystectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AEP17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotional Freedom Liberation Technique Applied to Laparoscopic Cholecystectomy Patients', 'description': 'The intervention group is the group in which the investigators applied Emotional Freedom Liberation Technique Intervention: Behavioral: Emotional Freedom Liberation Technique', 'interventionNames': ['Behavioral: Emotional Freedom Liberation Technique']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Clinical Care Applied to Laparoscopic Cholecystectomy Patients', 'description': 'The control group is the group that receives standard clinical care'}], 'interventions': [{'name': 'Emotional Freedom Liberation Technique', 'type': 'BEHAVIORAL', 'description': 'The investigators will apply Emotional Freedom Liberation Technique', 'armGroupLabels': ['Emotional Freedom Liberation Technique Applied to Laparoscopic Cholecystectomy Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25070', 'city': 'Erzurum', 'state': "ABD Veya Kanada'da Lütfen Seçin ...", 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asistant Professors', 'investigatorFullName': 'Ayşegül Yayla', 'investigatorAffiliation': 'Ataturk University'}}}}