Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT06881212
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2025-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects Of Therapeutic Approaches On Intubation Response, Agitation Behavior, And Extubation Time İn Patients Undergoing Open Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The research is a quasi-experimental study with a post-test experimental-control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Richmond Agitation Sedation Scale (RASS)', 'timeFrame': 'Within 12 weeks after the initial registration date,after the operation', 'description': "The scale was developed by the Virginia Commonwealth University of Richmond. In the scale, which has a total score of 10, the patient's agitation is scored in the reference range of +4 (combative; potentially dangerous for staff) to -5 (cannot be aroused). Scoring is done as; +4 belligerent, +3 very agitated, +2 agitated, +1 restless, 0 calm/awake, -1 sleepy, -2 light sedation, -3 moderate sedation, -4 deep sedation and -5 coma. A positive score indicates that the patient is agitated and a negative score indicates that the patient is in a coma or under the influence of sedation .Written permission for the scale was obtained via e-mail."}, {'measure': 'Intubation responses observation form', 'timeFrame': 'Within 12 weeks after the initial registration date after the operation', 'description': "In this observation form, 6 of the most common behaviors (Trying to pull the intubation tube, biting the intubation tube, wrinkled facial expression, collecting sheets with hands, trying to take the legs out of the bed railing, showing compliance with the ventilator) were examined by examining the literature and taking into account the changes indicated by 8 experts in the field according to the opinion form. In the form consisting of 6 sections, each item is graded on a 5-point Likert-type scale. (0=Behavior Not Observed; 4=Sustained Observed) The intubation behaviors observation form score is obtained by summing the scores of the questions. A high score indicates poor compliance with intubation. The Cronbach's alpha value of this scale was determined as 0.824 for this study.Intubation length of stay was recorded."}], 'primaryOutcomes': [{'measure': 'Sociodemographic information form', 'timeFrame': 'From the data obtained from the enrollment of the first participant until week 12 Before the operation', 'description': 'The demographic characteristics of the patients such as age, gender, education level, chronic diseases, history of surgery, height and weight, smoking and alcohol use, psychiatric treatment and follow-up status were evaluated with a 13-item form created by the researchers by using the literature.'}, {'measure': 'Numerical anxiety scale', 'timeFrame': 'From the data obtained from the enrollment of the first participant until week 12 Before the operation', 'description': 'The Numerical Anxiety scale has a starting point of "0" or "no anxiety" and an ending point of \'10\' or "severe anxiety" (horizontal line was used in this study). The patient chooses the number from the scale that best describes him/her. Preoperative and postoperative anxiety is higher in patients undergoing open heart surgery compared to other surgeries. Anxiety level is a factor that may lead to increased agitation and patient non-compliance with mechanical ventilator. For this reason, anxiety level was used as a control variable to measure the effectiveness of the intervention to be applied to the experimental and control groups and to ensure the homogeneity of the experimental and control groups. The results of the scale were evaluated on the arithmetic mean.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Education,', 'Nursing', 'Cardiovascular Surgery', 'Therapeutic Approach'], 'conditions': ['Cardiac Surgery Subjects', 'Nursing Care']}, 'referencesModule': {'references': [{'pmid': '22916068', 'type': 'BACKGROUND', 'citation': 'Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.'}, {'pmid': '18291244', 'type': 'BACKGROUND', 'citation': 'Hoyer J, Eifert GH, Einsle F, Zimmermann K, Krauss S, Knaut M, Matschke K, Kollner V. Heart-focused anxiety before and after cardiac surgery. J Psychosom Res. 2008 Mar;64(3):291-7. doi: 10.1016/j.jpsychores.2007.09.009.'}, {'type': 'BACKGROUND', 'citation': "İnce, F. (2020). Kardiyak cerrahi öncesi uygulanan eğitimin anksiyete, depresyon, yaşam kalitesi ve kinezyofobi üzerine etkisi (Master's thesis, İstanbul Medipol Üniversitesi Sağlık Bilimleri Enstitüsü)."}], 'seeAlsoLinks': [{'url': 'https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php', 'label': 'Calculatorsoup.com. Random Number Generator. (2022) (Accessed: 16.08.2022).'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted to understand how training given to patients before and after open-heart surgery affects their reactions during intubation (when a breathing tube is inserted), their agitation levels, and the time it takes to remove the breathing tube.\n\nStudy Design\n\nThe research followed a quasi-experimental design, meaning patients were divided into two groups:\n\nExperimental Group - Received special training before and after surgery. Control Group - Received standard hospital care without additional training. Key Variables Independent Variable (What was changed): The training given before and after surgery.\n\nDependent Variables (What was measured):\n\nPatient reactions during intubation Agitation levels Time taken to remove the breathing tube Study Hypotheses Patients who received the training would show different reactions compared to those who did not.\n\n1.1. The trained group would show fewer negative reactions during intubation. Patients who received the training would have different agitation levels compared to the control group.\n\n2.1. The trained group would be less agitated. The time taken to remove the breathing tube would be different between the two groups.\n\n3.1. The trained group would have their breathing tube removed faster. Where and When Was the Study Conducted? The research took place at Bezmialem Vakif University Hospital in Istanbul in the cardiovascular surgery department, between October 10, 2022 - January 7, 2023.\n\nParticipants The study initially considered 123 patients who had undergone open-heart surgery during this period.\n\nPatients were selected based on certain health conditions and criteria (age, no chronic respiratory disease, type of surgery, etc.).\n\nAfter applying these criteria, 30 patients (15 in each group) were included in the final study.\n\nHow Were Patients Selected? To ensure fairness, patients were randomly assigned to either the experimental or control group.\n\nA computer-generated random list was used to assign them. Who Was Included in the Study? Patients who had Coronary Artery Bypass (CABG), Aortic Valve Replacement (AVR), or Mitral Valve Replacement (MVR) surgery.\n\nPatients aged 45-70 years old. Who Was Excluded? Patients with chronic respiratory disease (as it could affect intubation time). Patients who had previous open-heart surgery (as prior experience could influence their reaction).\n\nPatients who did not speak Turkish or had cognitive issues. Patients with severe psychiatric conditions. Data Collection \\& Training Process\n\nBefore the surgery:\n\nPatients were asked about their age, gender, smoking habits, medical history, and other factors.\n\nTheir anxiety levels were measured using a scale from 0 to 10 (0 = No anxiety, 10 = Extreme anxiety).\n\nTraining for the experimental group:\n\nA special 40-50 minute training session was given a day before surgery. The training included breathing techniques, relaxation methods, and information about what to expect during recovery.\n\nFamily members were also involved.\n\nAfter the surgery:\n\nPatients were sedated as part of hospital protocol and then observed when they first woke up in the Intensive Care Unit (ICU).\n\nThe trained group received additional therapeutic communication techniques when they first woke up to help them stay calm.\n\nThe control group received only standard hospital care. Four hours after waking up, all patients were evaluated for their agitation levels and reactions to intubation.\n\nHow Were Reactions Measured? Richmond Agitation Sedation Scale (RASS ) - This measured how restless or calm the patient was.\n\nObservation of Intubation Reactions - The research team noted behaviors such as:\n\nTrying to pull out the breathing tube Biting the tube Facial expressions (like frowning or grimacing) Grabbing bed sheets Moving legs restlessly Breathing in sync with the ventilator Each behavior was scored from 0 (Not observed) to 4 (Strongly observed). A higher score meant the patient was more uncomfortable with intubation.\n\nResults General reactions to intubation (measured with a scale) were similar in both groups.\n\nHowever, when specific behaviors were examined, the control group had more visible distress:\n\nMore frowning and wrinkled facial expressions (p=0.030). More grabbing of bed sheets (p=0.013). There was no significant difference in agitation levels between the two groups. The time taken to remove the breathing tube was also not significantly different between the two groups.\n\nConclusion The special pre- and post-surgery training helped patients remain more comfortable during intubation, reducing visible signs of distress.\n\nHowever, the training did not significantly impact overall agitation levels or the time needed to remove the breathing tube.\n\nThis suggests that therapeutic communication techniques may improve patient comfort but do not necessarily speed up the recovery process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary Artery Bypass Graft, Aortic Valve Replacement, Mitral Valve Replacement having undergone one of these operations\n* No Chronic Respiratory Disease\n\nExclusion Criteria:\n\n* Aortic Valve Replacement and Mitral Valve Replacement performed together\n* Use of a method other than median sternotomy\n* Redo coronary bypass surgery\n* Illiteracy and not knowing Turkish\n* Being under psychiatric treatment and follow-up recently (last 1 year)'}, 'identificationModule': {'nctId': 'NCT06881212', 'briefTitle': 'Effects Of Therapeutic Approaches On Intubation Response, Agitation Behavior, And Extubation Time İn Patients Undergoing Open Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Effects Of Therapeutic Approaches On Intubation Response, Agitation Behavior, And Extubation Time İn Patients Undergoing Open Heart Surgery', 'orgStudyIdInfo': {'id': 'E-54022451-050.05.04-73654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trained group', 'description': 'Pre-Surgery:\n\nPatients received a special training including therapeutic communication techniques.\n\nThe training was prepared by reviewing the literature and integrated into hospital practices.\n\nOne day before surgery, the patient and patient\'s relatives were trained in a session lasting 40-50 minutes.\n\nAll stages of the training were monitored using the "Preoperative Training Checklist ".\n\nPostoperative:\n\nWhen the patients were taken to the intensive care unit, sedation was applied again at the first awakening according to the hospital protocol.\n\nAfter the effect of sedation wore off and the patient was conscious but still intubated, therapeutic interventions were performed.\n\nThis process was done with the "Postoperative Education Checklist " prepared based on the literature.\n\nData Collection:\n\n4 hours after the patients woke up, by the researcher: RASS (Richmond Agitation Sedation Scale) was applied. Intubation Reactions Form was filled. The time to come out of intubation was recorded.', 'interventionNames': ['Behavioral: THERAPEUTIC APPROACH TRAINING']}, {'type': 'NO_INTERVENTION', 'label': 'Non-training group', 'description': 'Preoperative No special training was given to the control group. Patients were only subjected to routine hospital procedures.\n\nPostoperative:\n\nStandard hospital protocol was applied when the patients were admitted to the intensive care unit.\n\nSedation was applied again, but no additional therapeutic intervention was performed.\n\nPatients received only routine nursing care.\n\nData Collection:\n\n4 hours after patients woke up, by the investigator: RASS (Richmond Agitation Sedation Scale) was administered. Intubation Reactions Form was completed. The time to come out of intubation was recorded.'}], 'interventions': [{'name': 'THERAPEUTIC APPROACH TRAINING', 'type': 'BEHAVIORAL', 'description': "This study focuses on pre- and post-operative training for open-heart surgery patients, aiming to reduce anxiety, agitation, and discomfort during intubation and recovery.\n\nIn the meeting phase, the nurse introduces herself, explains the research, and obtains written/verbal consent. The patient's anxiety level is assessed.\n\nIn the study phase, patients are informed about the surgical process, breathing exercises, Intensive Care Unit conditions, and postoperative care. They are encouraged to express fears and concerns to improve psychological preparedness.\n\nKey topics include:\n\nFasting before surgery Breathing exercises to ease extubation Use of mechanical ventilation Intensive Care Unit environment \\& pain management Early mobilization \\& recovery timeline Patients receive guidance on their role in recovery, ensuring better adaptation and reduced distress post-surgery.", 'armGroupLabels': ['Trained group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Kartal', 'country': 'Turkey (Türkiye)', 'facility': 'Gedik University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'I WANT TO PUBLISH IT AS AN ARTICLE IN A SCIE INDEXED JOURNAL'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Prof', 'investigatorFullName': 'Nareg Dogan', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}