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

NCT07100275 | Not Yet Recruiting DMC

• 1 other identifier: BU-SHMYO-IE-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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).

  1-2 Month

Secondary Outcomes (2)

• Richard-Campbell Sleep Scale (RCS):

  1-2 Months

• Surgical Fear Scale

  1-2 Months

Study Arms (2)

Standard Clinical Care

NO INTERVENTION

Control Group

Follow-up via Mobile Health Application

EXPERIMENTAL

Intervention Group

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

Interventions

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.

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

Follow-up via Mobile Health Application

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.

Follow-up via Mobile Health Application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bingol University: lead

Study Sites (1)

Bingol Universty

Bingöl, Central, 12000, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 37830734 RESULT

• 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.

  PMID: 38935953 RESULT

• 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.

  PMID: 36040069 RESULT

• 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.

  PMID: 36658058 RESULT

Related Links

• Bingöl State Hospital

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• izzettin e researcher

  STUDY DIRECTOR

• aynur koyuncu, Assistant Professor

  Hasan Kalyoncu University

  STUDY DIRECTOR

Central Study Contacts

Izzettın E Principal Investigator and Lecturer, PhD in Public Health

CONTACT

+905424662246; ekinciizzet21@gmail.com

bıngol University, Vocational School

CONTACT

+90 426 216 00 12; iekinci@bingol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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/).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: INSTRUCTOR

Model Details: two-group randomized controlled trial

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: August 3, 2025
• Study Start: August 20, 2025
• Primary Completion: September 10, 2025
• Study Completion: December 30, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)