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

The Effect of Video-Supported Online Preoperative Education on Fear, Anxiety, Sleep, and Stress in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07100275
Enrollment
128
Registered
2025-08-03
Start date
2025-08-20
Completion date
2025-12-30
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Laparoscopic cholecystectomy, Preoperative education, Preoperative anxiety, Surgical fear, Sleep quality, Stress levels

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.

Interventions

BEHAVIORALPatient 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.

BEHAVIORALFollow-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.

Sponsors

Bingol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

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/).

Intervention model description

two-group randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Comparison Scale (VCS)-Anxiety1-2 MonthIt 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).

Secondary

MeasureTime frameDescription
Richard-Campbell Sleep Scale (RCS):1-2 MonthsRichard-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.
Surgical Fear Scale1-2 MonthsThis 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactIzzettın E Principal Investigator and Lecturer, PhD in Public Health
ekinciizzet21@gmail.com+905424662246
Backup Contactbıngol University, Vocational School
iekinci@bingol.edu.tr+90 426 216 00 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026