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Clinical Trials/NCT06830330
NCT06830330RecruitingNot Applicable

Effect of Virtual Reality Application on Anxiety and Fear in Patients Undergoing Laparoscopic Abdominal Surgery: a Randomized Controlled Study

Cukurova University1 site in 1 country46 target enrollmentStarted: August 20, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
46
Locations
1
Primary Endpoint
State Anxiety Level Change

Study Overview

Brief Summary

The goal of this clinical trial is to learn if virtual reality application effects on anxiety and fear in patients who will undergo abdominal surgery.

It will also learn about the practical of virtual reality application in preoperative theatre. The main questions it aims to answer are:

  • Does virtual reality reduce patient anxiety levels before surgery?
  • Is virtual reality useful for patients to watch videos in the preoperative area? Researchers will compare virtual reality videos to routine nursing care to see if virtual reality works to treat preoperative anxiety and surgical fear.

Participants will:

  • watch videos of nature scenes with VR glasses in the waiting area before surgery.
  • answer the surgical fear quastionairre items for preoperative fear test

Detailed Description

Research Design This study aims to determine the effect of virtual reality glasses on the anxiety and fear experienced by patients undergoing abdominal surgery. The randomized, controlled and interventional study blinded the participants using a single-blind method.

Participants The study was conducted in the general surgery clinic of Balcalı Hospital Health Application and Research Center and the waiting room (preoperative area) of the operating room affiliated to this clinic. The research universe consisted of patients who were examined in the general surgery clinic and planned to undergo abdominal surgery under general anesthesia using the laparoscopic method. For this purpose, the researchers conducted a preliminary interview with the patients admitted to the clinic the night before the surgery. Among the patients who were interviewed, patients who were able to communicate and accepted to participate in the study, aged over 18 were included. Patients who used glasses, had an ASA score above 3, had vertigo and motion sickness-motion sickness, and had a known psychiatric or behavioral diagnosis were excluded from the study.

The study was based on the study by Gökçe and Arslan (2023), and when type 1 error was taken as 0.05, power was taken as 80%, and effect size was taken as 0.86, the sample size was calculated as 46 in total, 23 in both groups, in order to find a significant difference between the groups. The included patients were divided into intervention and control groups with simple randomization method. The study was completed by analyzing the data of 24 patients in the experimental group and 23 patients in the control group.

Data Collection During the data collection phase, the "Patient Introduction Form" created in line with the literature was used to define the sociodemographic characteristics of the participants. For other parameters; "State-Trait Anxiety Inventory", "Surgical Fear Scale" were used.

Patient Introduction Form: The section containing the patient's demographic data includes questions regarding age, gender, body mass index, education, marital status, presence of chronic disease, surgical experience, smoking, preoperative fasting period and the type of surgery to be performed.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Participants were blinded using a single-blind method.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients scheduled for abdominal surgery under general anesthesia using the laparoscopic method
  • •Patients who can communicate
  • •Patients who agree to participate in the study
  • •Patients over the age of 18

Exclusion Criteria

  • •Patients who use glasses
  • •Patients with an ASA score above 3
  • •Patients with vertigo and motion sickness
  • •Patients with known psychiatric or behavioral diagnoses

Arms & Interventions

Control Group

No Intervention

Control group

Virtual Reality Group

Experimental

Virtual Reality Group

Intervention: Virtual reality (Behavioral)

Outcomes

Primary Outcomes

State Anxiety Level Change

Time Frame: The state anxiety scale were applied to the patients 15 minutes after they watched the video with virtual reality glasses.

The effect of virtual reality intervention on preoperative anxiety level is safely evaluated.

Secondary Outcomes

  • Change in fear level related to surgery(The surgical fear scale were applied to the patients 15 minutes after they watched the video with virtual reality glasses.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nursevim Aydıngülü

Research assisstant

Cukurova University

Study Sites (1)

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