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Gallbladder stone disease is among the most common digestive system problems worldwide. The global incidence of gallstones is estimated to be 10-20%. In Europe, this rate is approximately 20%. In Turkey, the incidence of gallstones is accepted as 6% and it is estimated that an average of 4 million people have gallstones. ). Laparoscopic cholecystectomy is the most commonly used minimally invasive technique in the surgical treatment of gallbladder diseases. Although this is a technique, it also has many complications. Although drains placed after surgery are protective and therapeutic, they may cause some complications. Due to all these reasons, there are disadvantages such as lack of training and incomplete information given to the patient before surgery, and the patient not knowing what to do in physiological and psychological preparation before surgery. This training and information seems to be important in post-operative recovery and shortening the hospital period. Pre-surgical virtual training enables early detection of changes in the patient's vital signs, early intervention, and reduction of the number of home visits.
This study aims to examine the effect of online education given preoperatively to patients undergoing laparoscopic cholecystectomy surgery on fear, anxiety, sleep and stress.
This randomized controlled trial will be carried out in Bingöl State Hospital Surgical Service between 2024-2025. The research population consists of patients who underwent Laparoscopic Cholecystectomy surgery in this hospital between the specified dates.
will create. The research sample will consist of 128 patients who voluntarily participate in the research.
The data to be used in the research consists of the patients' introductory information form, clinical information and survey results, and a number of tests to be measured by taking blood. While demographic information includes basic information such as age, gender, marital status and educational status, clinical information includes details about the patient's preoperative process. Survey data includes evaluations of fear, anxiety and sleep, and blood tests include serum cortisol level and serum glucose level.
The collected data will be analyzed in the SPSS statistical analysis program. In statistical analyses, methods such as descriptive statistics, t-test, ANOV will be used and relationship-seeking analyzes will be conducted on the factors affecting stress formation.
This research aims to determine the effect of online education applied to prevent fear, anxiety and stress before laparoscopic cholecystectomy surgery. The positive effects of preoperative online education on patients, whether it reduces fear, anxiety and stress, and its effects on the patient's general well-being will be evaluated.
This study, which investigates the effect of online education applied to prevent fear, anxiety and stress before laparoscopic cholecystectomy surgery, aims to make a significant contribution to the literature in this field. The findings may contribute to more effective and holistic online patient education before laparoscopic cholecystectomy surgery.
In this project, a multidisciplinary approach has been adopted and members of the team from different areas of expertise will contribute according to their areas of expertise at different stages of the project. This is critical to the successful completion of the project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Clinical Care | No Intervention | Control Group | |
| Follow-up via Mobile Health Application | Experimental | Intervention Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient education | Behavioral | In addition to the procedures in the control group, the patient will be informed about the surgery while he/she is at home the day before the surgery. Information will be provided about the hospital and surgical process. If there are any questions, the patient will be asked and their concerns will be resolved. T0-T1-T2 procedures will be performed on patients in the intervention group, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Comparison Scale (VCS)-Anxiety | It consists of a 10-cm-long horizontal line. The left side contains the labels "I don't have anxiety" and the right side "I feel a lot of anxiety." The VAS value is determined by measuring the distance between the leftmost end of the scale and the marked point. Values range from 0 to 10, with higher values indicating increased anxiety (Cline et al., 1992). | 1-2 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Richard-Campbell Sleep Scale (RCS): | Richard-Campbell Sleep Scale (RCS): Developed by Richard Campbell in 1987, this scale consists of six items that measure the quality and depth of sleep, duration of sleep, and the noise level in the sleep environment. As the scale score increases, so does sleep quality. The Cronbach's alpha for the scale was found to be 0.82. | 1-2 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Izzettın E Principal Investigator and Lecturer, PhD in Public Health | Contact | +905424662246 | ekinciizzet21@gmail.com | |
| bıngol University, Vocational School | Contact | +90 426 216 00 12 | 5077 | iekinci@bingol.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| izzettin e researcher | Study Director | |
| aynur koyuncu, Assistant Professor | Hasan Kalyoncu University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bingol Universty | Bingoel | Central | 12000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37830734 | Result | Flores A, Hoffman HG, Navarro-Haro MV, Garcia-Palacios A, Atzori B, Le May S, Alhalabi W, Sampaio M, Fontenot MR, Mason KP. Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery. Healthcare (Basel). 2023 Oct 9;11(19):2697. doi: 10.3390/healthcare11192697. | |
| 38935953 | Result | Maheta B, Shehabat M, Khalil R, Wen J, Karabala M, Manhas P, Niu A, Goswami C, Frezza E. The Effectiveness of Patient Education on Laparoscopic Surgery Postoperative Outcomes to Determine Whether Direct Coaching Is the Best Approach: Systematic Review of Randomized Controlled Trials. JMIR Perioper Med. 2024 Jun 27;7:e51573. doi: 10.2196/51573. |
| Label | URL |
|---|---|
| Bingöl State Hospital | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Supervisory authority | Study Protocol | View IPD |
Individual participant data will not be shared publicly due to ethical restrictions and data protection policies.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2025 |
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two-group randomized controlled trial
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Patients whose eligibility for the study is assessed will be stratified as male and female and then randomly assigned to two groups, the study and control groups, in a blinded manner, using the randomizer org. computer program (https://randomizer.org/).
|
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| Follow-up via Mobile Health Application | Behavioral | The researcher will create a video depicting the process of transferring patients from the ward to surgery. The video will be created with a volunteer mannequin. It will not be created with a real patient. This video will be recorded during a non-busy Sunday at the hospital. This video will be shown to patients the evening before surgery, following online education, and their questions will be answered. |
|
| Surgical Fear Scale | This scale was developed by Theunissen and colleagues in 2014 to determine the fear level of patients undergoing elective surgery. The scale consists of eight items and is scored from 0 to 10. The total score is 0, with a minimum score of 80 and a maximum score of 80. Higher scores indicate higher levels of surgical fear. The Cronbach's alpha reliability coefficient for the scale was calculated as 0.89. | 1-2 Months |
| 36040069 | Result | Richey AE, Hastings KG, Karius A, Segovia NA, Caruso TJ, Frick S, Rodriguez S. Virtual Reality Reduces Fear and Anxiety During Pediatric Orthopaedic Cast Room Procedures: A Randomized Controlled Trial. J Pediatr Orthop. 2022 Nov-Dec 01;42(10):600-607. doi: 10.1097/BPO.0000000000002250. Epub 2022 Aug 30. |
| 36658058 | Result | Abbasnia F, Aghebati N, Miri HH, Etezadpour M. Effects of Patient Education and Distraction Approaches Using Virtual Reality on Pre-operative Anxiety and Post-operative Pain in Patients Undergoing Laparoscopic Cholecystectomy. Pain Manag Nurs. 2023 Jun;24(3):280-288. doi: 10.1016/j.pmn.2022.12.006. Epub 2023 Jan 17. |
The management that gives the necessary permission in the hospital where the study will be conducted |
| Jul 15, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 16, 2025 | Jul 30, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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