Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT07078656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Video Training on Patients' Self-Efficacy After Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-21', 'studyFirstSubmitDate': '2025-07-13', 'studyFirstSubmitQcDate': '2025-07-13', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Efficacy Scale in Colorectal Cancer Surgery', 'timeFrame': 'one week after registration up to 3 months', 'description': 'This 16-question scale is scored using a Likert scale ranging from "not at all sure" to "very sure" (0-10). Questions include the ability to detect changes in the wound site (edema, redness, discharge, pain, discoloration, and increased temperature), timely medication use, dressing, seeking medical attention, regulating diet, detecting urinary changes, maintaining social relationships, and avoiding strenuous exercise. A higher score indicates an increase in self-efficacy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual reality video training', 'colorectal surgery', 'self-efficacy'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to determine the effect of virtual reality video training on the self-efficacy of patients after colorectal surgery. Thus, correct planning can be provided for trainings that will provide information to patients according to their needs during the nursing care process.\n\nDoes virtual reality video training have an effect on participants' perceptions of self-efficacy after colorectal surgery? The researchers will conduct the self-efficacy survey on another group of participants without repeating the training to see the impact of the training.\n\nParticipants in the experimental group will receive training on the second postoperative day and they will apply a self-efficacy survey on the tenth day after discharge.\n\nParticipants in the control group will not receive training on the second postoperative day. They will complete a self-efficacy survey on the tenth day after discharge.", 'detailedDescription': 'The data obtained in the study will be evaluated in a computer environment using the IBM SPSS Version 22.0 package program. The conformity of the data to normal distribution will be assessed using the Kolmogorov-Smirnov test, and if the p value is p\\<0.05, Skewness and Kurtosis values will be examined. Descriptive statistics will be applied to sociodemographic variables. For intergroup comparisons of pre-test and post-test measurements of the experimental and control groups according to dependent variables, the significance test for the difference between two independent means will be used; for non-parametric data, the Mann Whitney U test will be used. For comparisons of pre-test and post-test measurements within the experimental and control groups according to dependent variables, the t-test for dependent groups will be used; for non-parametric data, the Wilcoxon test will be used. The results will be evaluated at a 95% confidence interval and a significance level of p\\<0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'IInclusion Criteria:\n\n* aged 18 and over\n* aged 65 and under\n* undergoing laparoscopic general surgery under general anesthesia\n* with no vision, hearing, or perception problems\n* with no communication problems\n* without nausea, vomiting, dizziness, etc.\n* with an ASA score of I, II, or III\n* who voluntarily agreed to participate in the study\n\nExclusion Criteria:\n\n* who have not undergone laparoscopic surgery\n* who are hemodynamically unstable\n* with an ASA score of IV\n* with neurological or psychological problems\n* Emergency and unplanned cases'}, 'identificationModule': {'nctId': 'NCT07078656', 'briefTitle': "Effect of Video Training on Patients' Self-Efficacy After Colorectal Surgery", 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': "Effect of Video Training on Patients' Self-Efficacy After Colorectal Surgery", 'orgStudyIdInfo': {'id': 'AnkaraYBU-SBF-GG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Glasses', 'description': 'Virtual reality glasses are a technological product that provides the human mind with the perception of real space and features of images arranged in a computer environment in 3 dimensions. It is also used as an educational tool, which is widely used in daily entertainment venues.', 'interventionNames': ['Behavioral: Postoperative management']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'In the control group, after obtaining permission with the "Informed Consent Form" one day before the surgery, the patients who agreed to participate in the study will fill out the "Patient Introduction Form" by the researchers, they will not receive any intervention and will be provided with routine nursing care provided in the hospital. The "Self-Efficacy Scale" will be applied when the patient comes for a check-up 10 days after discharge.'}], 'interventions': [{'name': 'Postoperative management', 'type': 'BEHAVIORAL', 'description': 'The patients who agreed to participate in the study will be asked to fill out a "Patient Introduction Form" by the researchers after obtaining permission from the experimental group with the "Informed Consent Form" the day before the surgery. On the 2nd day after laparoscopic colorectal surgery, virtual reality glasses will be worn by the patients and they will watch a 10-minute training video on the care of the patient after colorectal surgery. The training content will consist of topics such as dressing the surgical area, signs of infection in the surgical area (redness, swelling, discharge, color, temperature increase), pain management, unexpected situations (fever, nausea, abdominal pain, shivering, chan)', 'armGroupLabels': ['Virtual Reality Glasses']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'GÜLÇİÇEK TÜRKGENÇ', 'role': 'CONTACT', 'email': 'cicek.gungor153@gmail.com', 'phone': '+90 507 164 4838'}], 'overallOfficials': [{'name': 'Tuba Yılmazer, Ass. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Yildirim Beyazıt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Student', 'investigatorFullName': 'Gülçiçek Güngör', 'investigatorAffiliation': 'Ankara Yildirim Beyazıt University'}}}}