The Effect of Video-Supported Online Preoperative Education on Fear, Anxiety, Sleep, and Stress in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised Controlled Trial
Phase: NA
Conditions: Patient Education, Surgical Fear and Worrying, Surgical Stress Response, Medical-surgical Nursing
Sponsor: Bingol University

Official Title of the Study: Effect of Video-Assisted Online Preoperative Education on 
Fear, Anxiety, Sleep and Stress in Patients Undergoing Laparoscopic Cholecystectomy: 
Randomized Controlled Study 
NCT Number: Not yet assigned at time of submission 
Date of the Document: February 10, 2025 
Aim : The overall objective of this study was to examine the effects of online preoperative 
education on fear, anxiety, sleep patterns, and stress levels in patients undergoing 
laparoscopic cholecystectomy. The aim was to assess the potential ameliorative effects of 
online education on these negative emotional states by improving patients' understanding 
of the surgical process and their sense of security. 
Ethical Aspects of the Research 
Before initiating the research, the subject was approved by the Hasan Kalyoncu Graduate 
Institute Ethics Committee (Approval No: 2024/5). 
Before initiating the research, permission was obtained from the Bingöl University 
Rectorate Health Sciences Scientific Research and Publication Ethics Committee (Ethics 
Approval No: E-33117789-044-171830). Additionally, permission was obtained from the 
Harran University Clinical Research Ethics Committee (Ethics Approval No: HRÜ/25.03.49). 
Institutional permission was also obtained from the Bingöl Provincial Health Directorate 
where the research would be conducted (Approval No: E-45082128-105.05.04-254841450). 
Written permission was obtained from the authors who adapted the Surgical Fear Scale 
(SFS), Visual Comparison Scale (VCS), and Richards Champell Sleep Scale (RCS) into Turkish 
and conducted their validity and reliability studies. Patients will be informed about the 
study both verbally and in writing (Emanuel EJ 2004). All stages of the study will be 
conducted in accordance with the ethical principles outlined in the World Medical 
Association Declaration of Helsinki (WMA Helsinki). 
Research Type, Location, and Timeframe 
The study will be a randomized controlled clinical trial conducted in the general surgery 
ward of Bingöl State Hospital. 
Research Population and Sample 
The study will consist of patients presenting to the general surgery ward of Bingöl State 
Hospital. The study sample will consist of patients who volunteered to participate in the 
study (N: 128). 
The G* Power 3.1.9.7 program was used to calculate the sample size. A pyrrho calculation 
was performed, assuming that an independent samples t-test could be used to compare the 
scale scores (RCU-GKÖ-CÖ) between groups. Cohen's d (standard effect size) was used in 
the calculation (Cohen J 1998). Based on the two-sided hypothesis, a medium effect size of 
0.05, an α error of 0.05, a β error of 0.20, and a power of 80%, the minimum sample size 
for each group was determined to be 128 (N=128) for the intervention group (n=64), the 
control group (n=64), and the total sample size. Following completion of the study, a post 
hoc calculation will be conducted to retest the adequacy of the sample size. 
Research Implementation 
Research data will be collected by three nurses working on the ward where the study is 
conducted. The primary purpose of having these three nurses collect the data is to ensure 

that the measurements are carried out in a standardized, reliable, and unbiased manner. 
Because the researchers were responsible for planning and implementing the intervention 
in the study, they intentionally withdrew from the data collection process. This prevented 
the observer effect and limited the data collectors' access to group information by ensuring 
single-blindness. The three nurses who will participate in the data collection process will 
receive a standardized training process in advance regarding the scales to be used, 
measurement times, and biochemical data collection protocol, thus strengthening inter-
measurement consistency and internal validity. 
Statistical Analysis of Data 
Statistical analysis of the data will be performed using IBM SPSS 27.0 (IBM SPSS Inc., USA) 
for Windows. For descriptive statistics, number (n) and percentage (%) will be used for 
discrete values, and the mean ± standard deviation will be used for continuous numerical 
values. Data will be screened using the Kolmogorov-Simirnov and Shapiro-Wilk tests to 
determine whether the data are normally distributed. The independent samples t-test will 
be used to compare means of variables with a normal distribution (p>0.05), and the Mann-
Whitney U test will be used to compare means of variables with a non-normal distribution 
(p<0.05). The Chi-Square test will be used for discrete variables. A p<0.05 value will be 
accepted for statistical significance.