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Not yet recruitingNCT07100275Updated Aug 3, 2025

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

An interventional study of Patient education and Follow-up via Mobile Health Application in Patient Education, Surgical Fear and Worrying and Surgical Stress Response, sponsored by Bingol University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by Bingol University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Laparoscopic cholecystectomy
  • Preoperative education
  • Preoperative anxiety
  • Surgical fear
  • Sleep quality
  • Stress levels
03

In context

Sleep Initiation and Maintenance Disorders

1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.

This study's planned enrollment of 128 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Bingol University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
128 participants (estimated)

Study arms

  • No intervention
    Standard Clinical Care

    Control Group

  • Experimental
    Follow-up via Mobile Health Application

    Intervention Group

    Behavioral: Patient education · Behavioral: Follow-up via Mobile Health Application

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.

    Also known as: Online video-assisted patient education, Surgical fear and anxiety

  • 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1-2 Month

Secondary outcomes

  1. 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.

    Time frame: 1-2 Months

  2. 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.

    Time frame: 1-2 Months

07

Study locations

1 site
  • Bingol Universty
    Bingoel, Central 12000, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 37830734 ↗
  • 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. PubMed 38935953 ↗
  • 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. PubMed 36040069 ↗
  • 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. PubMed 36658058 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 10, 2025
  • Informed consent form · Jun 16, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data will not be shared publicly due to ethical restrictions and data protection policies.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07100275
Lead sponsor
Bingol University
Responsible party
Izzettin Ekinci (INSTRUCTOR, Bingol University) — Principal investigator
First posted
Aug 3, 2025
Start date
Aug 20, 2025 (estimated)
Primary completion
Sep 10, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Aug 3, 2025

Study contacts

Izzettın E Principal Investigator and Lecturer, PhD in Public Health
Contact
ekinciizzet21@gmail.com
+905424662246
bıngol University, Vocational School
Contact
iekinci@bingol.edu.tr
+90 426 216 00 12 ext. 5077
izzettin e researcher
study director
aynur koyuncu, Assistant Professor
study director · Hasan Kalyoncu University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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