Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:48 AM
Study NCT ID:
NCT07449559
Status:
COMPLETED
Last Update Posted:
2026-03-05
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nursing Intervention Guided by an ICD Nursing Guideline
Sponsor:
Organization:
Raw JSON
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To minimize the risk of contamination bias, data from the control group, which received routine care, were collected before the nursing guideline was implemented. Data for the control group were collected between August 16, 2021, and February 17, 2022, followed by the intervention group, which received care according to the nursing guideline from August 15 to November 17, 2022. Outcome data were collected after both groups received their respective care protocols.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction with Nursing Care', 'timeFrame': 'From enrollment to one month', 'description': 'Newcastle Satisfaction with Nursing Scale: measured patient satisfaction with nursing care in acute settings. The scale contains 19 statements rated on a five-point Likert scale. Scores are summed and converted to a range of 0-100, with higher scores indicating greater satisfaction.'}, {'measure': 'Florida Patient Acceptance Survey', 'timeFrame': 'From enrollment to one week and one month', 'description': 'Florida Patient Acceptance Survey (FPAS) The FPAS was developed by Burns et al. (2005) to measure patient acceptance of cardiac devices after implementation. Higher total scores reflect greater acceptance, while higher subscale scores are interpreted differently: higher scores on Return to Function and Positive Appraisal indicate greater acceptance, whereas higher scores on Device-Related Distress and Body Image Concerns reflect lesser acceptance.'}, {'measure': 'Self-Efficacy Expectations Scale', 'timeFrame': 'From enrollment to one week and one month', 'description': 'This scale measures confidence in coping with ICD-related problems. Responses are scored from 0 (not confident) to 10 (very confident).Higher scores indicate higher levels of self-efficacy'}, {'measure': 'Outcome Expectations Scale', 'timeFrame': 'From enrollment to one week and one month', 'description': 'Outcome Expectations Scale:Assesses perceived consequences of performing self-management behaviors, with responses rated from 0 (strongly disagree) to 5 (strongly agree).\n\nHigher scores indicate higher levels of outcome expectations.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['evidence-based nursing,', 'implantable cardioverter-defibrillator', 'nursing guideline', 'self-efficacy', 'device acceptance', 'outcome expectations', 'nursing care satisfaction'], 'conditions': ['Implantable Cardioverter-defibrillators (ICDs)']}, 'referencesModule': {'availIpds': [{'url': 'https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp', 'type': 'Study Protocol'}], 'seeAlsoLinks': [{'url': 'https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp', 'label': 'https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate evidence-based nursing intervention guided by an ICD nursing guideline on self-efficacy, device acceptance, satisfaction with nursing care, and outcome expectations among ICD candidates during the pre-and post-implantation periods.', 'detailedDescription': 'INTRODUCTION Implantable cardioverter defibrillators (ICDs) are globally utilized devices for the primary and secondary prevention of sudden cardiac death. They monitor heart rhythms, detect life-threatening ventricular arrhythmias, and deliver shocks to terminate these events, significantly reducing mortality rates . However, despite their life-saving potential, ICD recipients often face significant psychological challenges and difficulties adjusting to the device. These challenges include anxiety about unexpected shocks, limitations in daily, social, and sexual activities, and insufficient education and counseling from healthcare providers .\n\nPsychological distress, such as anxiety and depression, has been shown to increase the risk of mortality in ICD patients. In contrast, acceptance of the ICD can mitigate these risks, improving psychological outcomes. Patients who exhibit higher ICD acceptance tend to have better knowledge of the device, lower anxiety and depression levels, more positive attitudes, and strong support from healthcare professionals . Additionally, self-efficacy the belief in one\'s ability to perform specific behaviors and outcome expectations, which reflect confidence in the effectiveness of self-management behaviors, are critical for successfully adapting to life with an ICD. These factors are essential for addressing the behavioral and emotional challenges associated with ICD implantation .\n\nThe primary goal of ICD care is to educate and support patients in evidence-based ways, enabling them to balance the transition to living with the device. Providing structured pre- and post-implantation education and counseling prepares patients and their families for life with ICD. It helps them manage psychosocial stressors and cope with the unpredictability of shocks. Nurses play pivotal role in this process by offering education, counseling, and periprocedural care. Despite this, most nursing interventions focus on the post-implantation period, addressing psychosocial, behavioral, educational, and follow-up needs to improve patient outcomes and quality of life.\n\nEvidence suggests that nursing care for ICD candidates should commence at the decision to implant the device and continue throughout the post-implantation period. However, no nursing guidelines exist for the pre- and post-ICD care continuum. The development of an ICD nursing guideline with pre- and post-implementation recommendations, adapted from existing evidence-based guidelines, offers an innovative strategy in nursing literature that should be further explored. Moreover, the potential benefits of implementing such guidelines on early patient outcomes, including self-efficacy, device acceptance, nursing care satisfaction, and outcome expectations, have yet to be systematically investigated.\n\nThis study aimed to evaluate evidence-based nursing intervention guided by an ICD nursing guideline on self-efficacy, device acceptance, satisfaction with nursing care, and outcome expectations among ICD candidates during the pre-and post-implantation periods.\n\nMETHODS Design The quasi-experimental design was used.\n\nParticipants and Study Setting This study recruited 60 patients with ICDs between August 16, 2021, and November 17, 2022. The study was conducted at a tertiary hospital specializing in cardiovascular diseases in Ankara, Turkey. Participants were recruited from the preoperative/postoperative coronary angiography unit, where they were admitted for ICD implantation.\n\nPatients scheduled for implantation were first admitted to the cardiology department and provided an appointment. Following ICD implantation, patients were either observed overnight and discharged the next day or remained as inpatients in the cardiology department, depending on their clinical condition. Post-implantation follow-ups were scheduled for the 7th day (stitch removal) and the 30th day (device control).\n\nSample size A priori power analysis was performed using G\\*Power version 3.1.9.2 to calculate the minimum sample size required for the study. Data from Akay\'s (2023) study were utilized to estimate the effect size, which was determined to be medium (Cohen\'s d = 0.6). Based on a significance level of α = 0.05 and a statistical power of 0.80, the minimum sample size was calculated as 30 participants for the intervention group and 30 for the control group.\n\nPatients admitted to the preoperative/postoperative coronary angiography unit were screened for eligibility between August 16, 2021, and November 17, 2022. Of the 197 patients assessed, 95 did not meet the inclusion criteria. Eligible patients were approached consecutively, with control group participants being recruited first. The study was completed with 60 participants: 30 in the intervention group and 30 in the control group (Figure-1).\n\nMeasurements and Data Collection Data collection involved the use of the Patient Data Sheet, Discharge Form, Newcastle Satisfaction with Nursing Scale (NSNS), Florida Patient Acceptance Survey (FPAS), and Self-Efficacy Expectations (SE-ICD) and Outcome Expectations (OE-ICD) After Implantable Cardioverter Defibrillator Implantation scales. To minimize bias, data was gathered by a nurse not involved in the intervention team.\n\nThe NSNS was administered on the day of discharge, while the FPAS, SE-ICD, and OE-ICD scales were completed during face-to-face interviews on the 7th and 30th days post-implantation.\n\nNewcastle Satisfaction with Nursing Scale (NSNS) The NSNS, developed by Thomas et al. (1996), measured patient satisfaction with nursing care in acute settings. The scale contains 19 statements rated on a five-point Likert scale. The scale has a Cronbach\'s alpha of 0.96.\n\nFlorida Patient Acceptance Survey (FPAS) The FPAS was developed by Burns et al. (2005)to measure patient acceptance of cardiac devices after implementation. It consists of four subscales: return to function, device-related distress, positive appraisal and body ımage concerns.\n\nHigher total scores reflect greater acceptance, while higher subscale scores are interpreted differently: higher scores on Return to Function and Positive Appraisal indicate greater acceptance, whereas higher scores on Device-Related Distress and Body Image Concerns reflect lesser acceptance. The FPAS has a reliability coefficient of 0.81.\n\nSelf-Efficacy and Outcome Expectations Scales (SE-ICD and OE-ICD) The SE-ICD and OE-ICD scales, developed by Dougherty, Johnston, and Thompson (2007), were used to measure self-efficacy and outcome expectations post-ICD implantation.\n\nSelf-Efficacy Expectations Scale (SE-ICD): This scale measures confidence in coping with ICD-related problems. Responses are scored from 0 (not confident) to 10 (very confident).\n\nOutcome Expectations Scale (OE-ICD): Assesses perceived consequences of performing self-management behaviors, with responses rated from 0 (strongly disagree) to 5 (strongly agree).\n\nHigher scores on both scales indicate higher levels of self-efficacy and outcome expectations. Cronbach\'s alpha is 0.87 for the SE-ICD, and 0.75 for the OE-ICD scales .\n\nEthical consideration Approval for the study was obtained from Hacettepe University\'s Non-Interventional Clinical Research Ethics Committee (GO 16/689-06) and from the institution where the study was conducted. We conduct our study in compliance with the principles of the Declaration of Helsinki. Additionally, permission was secured to use the scales and instruments utilized in the study. Verbal and written informed consent were obtained from all patients and nurses participating in the survey, ensuring their voluntary participation and understanding of the study procedures.\n\nProcedures Before the intervention, an evidence-based nursing guideline was developed and implemented. The intervention provided pre- and post-ICD implantation care, guided by the newly established evidence-based nursing guideline.\n\nImplantable cardioverter defibrillator evidence-based nursing guideline development Clinical practice guidelines are widely used to improve patient care quality across healthcare settings. To enhance resource efficiency and leverage existing guidelines, guideline adaptation has become a critical approach to developing new clinical protocols. In this study, the ICD evidence-based nursing guideline was adopted in three phases-setup, adaptation, and finalization-according to the ADAPTE manual and resource toolkit, which consists of nine modules and 23 steps.\n\nDuring these phases, an extensive literature search explored guidelines and resources related to "nursing care for patients undergoing first-time ICD implantation, including pre-operative, post-operative, and discharge care." Seven available guidelines on nursing care for ICD patients focusing on pre-implantation, implantation, and post-discharge care were reviewed for their quality, validity, content, and applicability, based on the ADAPTE manual by a content expert panel, which included six clinicians and academics specializing in cardiology and nursing. The panel approved the recommendations from three of the guidelines.\n\nFor evidence analysis and synthesis, the Johns Hopkins Nursing Evidence Level and Quality Guideline and Synthesis Process and Recommendations Tool were utilized. The recommendations from the reviewed guidelines were compiled and integrated into a draft guideline. This draft was then reviewed by external experts (six clinical and academic ICD specialists), the developers of the source guidelines, and the content expert panel. After incorporating their feedback, a patient information booklet and a checklist tool were added, completing the final version of the ICD evidence-based nursing guideline.\n\nThe quality of the nursing guideline was assessed using the AGREE II tool, and the overall evaluation indicated that the guideline met high-quality standards.\n\nThe final nursing guideline consists of 27 recommendations for the pre-implementation period and 20 for the post-implementation period. These recommendations were categorized as follows:\n\nPre-implementation: Evaluation: 6 recommendations, Monitoring: 2 recommendations, Training and Counseling: 12 recommendations and Preparation for Implementation Day: 7 recommendations.\n\nPost-implementation: Evaluation: 5 recommendations, Monitoring: 6 recommendations, Training and Counseling: 7 recommendations, Regular Equipment Checks: 2 recommendations.\n\nThe complete guideline spans 83 pages and includes detailed descriptions of the evidence-based recommendations, the guideline\'s purpose and methodology, a checklist tool (Supplementary File 1), a patient booklet, and a patient identification card.\n\nImplantable cardioverter defibrillator evidence-based nursing guideline implementation The nursing guideline was implemented between Jul 18 and Nov 17, 2022, with guidance from the Johns Hopkins Nursing Evidence-Based Practice Toolkit Translation Phase. Eleven nurses from the preoperative/postoperative coronary angiography unit were directly involved in delivering care using the nursing guidelines. Implementing the nursing guideline followed the Johns Hopkins Nursing Evidence-Based Practice model translation phase in eight steps to incorporate the latest research and best practices into patient care (Supplementary file 2). The action plan was created. The plan\'s details were educating nurses regarding the evidence-based ICD guideline by the researcher, individual clinical training sessions in daily clinic visits by the researcher, using evidence-based practice tools ( ICD guideline, checklist, patient booklet, and patient ID card), and implementing the guideline in the clinic.\n\nIntervention This study evaluated the effectiveness of an ICD evidence-based nursing care intervention. To minimize the risk of contamination bias, data from the control group, which received routine care, were collected before the nursing guideline was implemented. Data for the control group were collected between August 16, 2021, and February 17, 2022, followed by the intervention group, which received care according to the nursing guideline from August 15 to November 17, 2022. Outcome data were collected after both groups received their respective care protocols.\n\nThe effectiveness of the intervention was assessed on the day of discharge and 7th and 30th day of post-implantation for both groups. The NSNS was administered on discharge. In contrast, the FPAS, SE-ICD, and OE-ICD scales were administered on 7th and 30th day of post-implantation. Literature suggests that a 4-week healing period offers a better reflection of patient adjustment, as the first week\'s post-ICD implantation represents a period of heightened patient needs, making early nursing interventions critical. Since days 7 and 30 are considered critical in the early period for ICD patients, data collection tools (FPAS, SE-ICD, and OE-ICD scales) were administered on these days.\n\nStatistical analysis Statistical analysis was performed using the software IBM SPSS version 25.0 (IBM Corporation, Armonk, NY, USA). Descriptive statistics were used to summarize the data, including mean, standard deviation, median, frequency, and percentages. The normality of the data was assessed using the Shapiro-Wilk test. Based on the normality results, the following statistical tests were applied: Fisher\'s exact probability test, Yates\' corrected chi-square test, Student\'s t-test, and Mann-Whitney test were used for data comparison. Fisher\'s Exact Probability Test and Chi-Square Test with Yates Correction were used to compare qualitative data; Student\'s t-test was used for two-group comparisons of quantitative data for normally distributed parameters. Mann-Whitney U test was used for two-group comparisons of parameters that did not show normal distribution. Results were considered statistically significant for significance level p\\<0.05'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were eligible for inclusion if they met the following criteria:\n\n * aged 18 years or older,\n * admitted to the preoperative/postoperative coronary angiography unit as an ICD candidate,\n * able to read and write in their native language, no speech, hearing, or vision impairments that could hinder participation in the nursing intervention and\n * willing to participate voluntarily in the study.\n\nExclusion Criteria:\n\n* Patients were excluded if they:\n\n * were hospitalized or transferred to another clinic post-implantation,\n * were referred for psychological counseling by the 30th day post-implantation,\n * could not be contacted on the 7th or 30th day post-implantation and withdrew from the study.'}, 'identificationModule': {'nctId': 'NCT07449559', 'briefTitle': 'Nursing Intervention Guided by an ICD Nursing Guideline', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Evidence-Based Nursing Intervention Guided by an ICD Nursing Guideline Improves Device Acceptance and Self-Efficacy in Patients With ICDs: A Quasi-Experimental Study', 'orgStudyIdInfo': {'id': 'GO 16/689-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'The control group received routine periprocedural care for ICD implantation', 'description': 'The control group received routine periprocedural care for ICD implantation. This included monitoring vital signs, hemodynamic assessment, blood tests, placement of an intravenous catheter, electrocardiogram (ECG), medical history review, medication management, physical examination, prophylactic antibiotics, patient fasting, and obtaining informed consent. Before the implantation, patients were informed about the procedure and their follow-up visit, incision care, medication regimen, arm protection, and X-ray avoidance. A patient identification card was provided at discharge. On the 7th day post-implantation, routine care included suture removal, and on the 30th day, a device check was performed.'}, {'type': 'EXPERIMENTAL', 'label': 'Patients in the intervention group received nursing care based on the ICD nursing guideline', 'description': 'Patients in the intervention group received nursing care based on the ICD evidence-based nursing guideline. Care protocol is detailed in Supplementary File 1. All nurses in the clinic used a periprocedural care checklist for ICD implantation, and each patient was educated using a booklet developed according to the ICD nursing guideline. During the 7-day post-implantation visit, which focused on suture removal, patients in the intervention group received care in alignment with the ICD nursing guideline, including education, counseling on ICD-related anxiety, and psychological assessment. On the 30th day, during the device check visit, additional and repeat education, counseling on ICD-related anxiety, and psychological assessment were provided to the intervention group.', 'interventionNames': ['Other: nursing care with an evidence-based ICD nursing guideline']}], 'interventions': [{'name': 'nursing care with an evidence-based ICD nursing guideline', 'type': 'OTHER', 'description': ". In this study, the ICD evidence-based nursing guideline was adopted in three phases-setup, adaptation, and finalization-according to the ADAPTE manual and resource toolkit, which consists of nine modules and 23 steps. The final nursing guideline consists of 27 recommendations for the pre-implementation period and 20 for the post-implementation period. The complete guideline spans 83 pages and includes detailed descriptions of the evidence-based recommendations, the guideline's purpose and methodology, a checklist tool, a patient booklet, and a patient identification card.The nursing guideline was implemented between Jul 18 and Nov 17, 2022, with guidance from the Johns Hopkins Nursing Evidence-Based Practice Toolkit Translation Phase.Patients in the intervention group received nursing care based on the ICD evidence-based nursing guideline.", 'armGroupLabels': ['Patients in the intervention group received nursing care based on the ICD nursing guideline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'İmatullah Akyar, RN,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'url': 'https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Study protocol is available on the web page of council of higher education thesis center in Turkey', 'ipdSharing': 'YES', 'description': 'the study protocol will be shared.', 'accessCriteria': 'everyone will access the web page of council of higher education thesis center in Turkey'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, MSN,PhD, Nurse', 'investigatorFullName': 'Arnel Boke Kilicli', 'investigatorAffiliation': 'Hacettepe University'}}}}