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NCT Number: NCT07100275

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Online video-assisted patient education, Surgical fear and anxiety

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.

Primary outcomes

  1. Visual Comparison Scale (VCS)-Anxiety

    Time frame: 1-2 Month

    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).

Secondary outcomes

  1. Richard-Campbell Sleep Scale (RCS):

    Time frame: 1-2 Months

    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.

  2. Surgical Fear Scale

    Time frame: 1-2 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Izzettın E Principal Investigator and Lecturer, PhD in Public Health

CONTACT

[email protected]

+905424662246

bıngol University, Vocational School

CONTACT

[email protected]

+90 426 216 00 12 ext. 5077

Sponsors and collaborators

Lead sponsor

Bingol University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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