The Effect of Video-Supported Online Preoperative Education on Fear, Anxiety, Sleep, and Stress

NCT ID: NCT07100275

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2025-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

Patient Education; Surgical Fear and Worrying; Surgical Stress Response; Medical-surgical Nursing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Standard Clinical Care

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Follow-up via Mobile Health Application

Intervention Group

Group Type: EXPERIMENTAL

Patient education

Intervention Type: 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.

Follow-up via Mobile Health Application

Intervention Type: 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.

Interventions

Patient education

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.

Intervention Type: BEHAVIORAL

Follow-up via Mobile Health Application

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Online video-assisted patient education; Surgical fear and anxiety

Eligibility Criteria

Inclusion Criteria

• Patients over the age of 18,
• Those who can speak and write Turkish (education level primary school and above),
• Those who have undergone laparoscopic cholecystectomy surgery for the first time,
• Those who are not receiving psychiatric treatment or taking medication,
• Those who do not have a chronic disease,
• Those who are not taking cortisone-type medication,
• Those who have a smartphone and know how to use it,
• Patients whose anesthesia evaluation was performed 1-3 days before the surgery,
• Patients who volunteer to participate in the study will be included in the study.

Exclusion Criteria

• Those whose surgery is canceled for any reason.
• Those who want to leave the study at any stage after volunteering to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bingol University

OTHER

Sponsor Role: lead

Responsible Party

Izzettin Ekinci

INSTRUCTOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

izzettin e researcher

Role: STUDY_DIRECTOR

aynur koyuncu, Assistant Professor

Role: STUDY_DIRECTOR

Hasan Kalyoncu University

Locations

Bingol Universty

Bingöl, Central, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Izzettın E Principal Investigator and Lecturer, PhD in Public Health

Role: CONTACT

ekinciizzet21@gmail.com

+905424662246

bıngol University, Vocational School

Role: CONTACT

iekinci@bingol.edu.tr

+90 426 216 00 12 ext. 5077

Facility Contacts

Bingol Universty

Role: primary

basinyayin@bingol.edu.tr

+9(0426) 216 00 12

References

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.

Reference Type: RESULT

PMID: 37830734 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38935953 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36040069 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36658058 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

Document Type: Study Protocol

The management that gives the necessary permission in the hospital where the study will be conducted

View Document

Related Links

https://bingoldh.saglik.gov.tr/

Bingöl State Hospital

Other Identifiers

BU-SHMYO-IE-01

Identifier Type: -

Identifier Source: org_study_id