The Effect of Video-Supported Online Preoperative Education on Fear, Anxiety, Sleep, and Stress in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Visual Comparison Scale (VCS)-Anxiety
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
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/).
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
Standard Clinical Care
Control Group
Follow-up via Mobile Health Application
Intervention Group
Intervention: Patient education (Behavioral)
Follow-up via Mobile Health Application
Intervention Group
Intervention: Follow-up via Mobile Health Application (Behavioral)
Outcomes
Primary Outcomes
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
- Richard-Campbell Sleep Scale (RCS):(1-2 Months)
- Surgical Fear Scale(1-2 Months)
Investigators
Izzettin Ekinci
INSTRUCTOR
Bingol University