- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05718661
The Effect of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients
The Effectiveness of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients: A Double-Blinded Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypothesis H1: The anxiety level of patients who watch relaxing video through VR is lower than that of those who do not.
H2: The stress level of patients who watch relaxing video through VR is lower than that of those who do not.
H3: The heart rate level of patients who watch relaxing video through VR is lower than that of those who do not.
This study was carried out between January 30, 2023 and December 20th 2024 at the General Surgery Service of a university hospital, which has a 48-bed capacity and accommodates 1-2 patients per room. The hospital is situated in the Trakya region of the Edirne province in Türkiye and serves as a major healthcare provider, offering a comprehensive range of medical services to the surrounding provinces and contributes to medical and health sciences education and research. At this service, nurses ensure that patients are prepared for surgery in accordance with the daily determined operating room schedule by instructing them to remove their clothing, except for their underwear, and put on their green surgical gowns and caps. Following this preparation, patients remain in their beds while awaiting the arrival of healthcare support personnel for their transfer to the operating room. This waiting period typically lasts between 20 to 25 minutes.
The sample size was calculated based on the study by Mosso et al. (2009) that evaluated the effect of virtual reality intervention on patients' anxiety levels in the preoperative period. An effect size of d=0.920 was obtained by comparing the pre- and post-interventional VAS-A score changes of the intervention group (2.2±2.94) and the control group (5.27±3.69). The G-Power software (G-Power 3.1.9.7, Kiel, Germany) was used for the sample size calculation, applying an effect size of d=0.920, an alpha error probability of 0.05, and a statistical power of (1-β err prob) = 0.95. As a result, a total of 96 patients were enrolled in the study, with 32 patients allocated to each group.
Patients aged ≥ 18 years, scheduled for elective abdominal surgery (including appendectomy, ileal/bowel surgery, hernia repair surgery, gallbladder/pancreas surgery) waiting at the service to be transferred to the operating room in the morning of surgery, and able to communicate and provide informed consent. Patients scheduled to undergo abdominal cancer surgery, those requiring unplanned surgery such as emergency cases, those in isolation, those with visual and/or auditory disabilities, and those with neurological problems such as vertigo were excluded.
In this study, data were collected using "Patient Information Form", "Visual Analog Scale-Anxiety (VAS-A)", and "Smart Bracelet".
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Edirne, Turkey (Türkiye), 22000
- Trakya University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria Patients aged ≥ 18 years
Scheduled for elective abdominal surgery (e.g., appendectomy, ileal/bowel surgery, hernia repair, gallbladder/pancreas surgery)
Awaiting transfer to the operating room on the morning of surgery
Able to communicate effectively
Able to provide informed consent
Exclusion Criteria Patients scheduled for abdominal cancer surgery
Patients undergoing unplanned or emergency surgery
Patients in isolation
Patients with visual and/or auditory impairments
Patients with neurological conditions such as vertigo
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Glasses Group
The intervention group will watch a virtual reality video with mobile virtual glasses by the researcher (SŞ) and the stress level on the smart wristband will be recorded.
In addition, necessary variables will be recorded with the data collection form.
|
Using Mobile Virtual Glasses; In the preoperative period, after the patient is taken to the surgical service, a virtual reality video will be watched with mobile virtual glasses at the specified time (before going to the operating room on the day of surgery).
Measurements will be made before and after the application.
Necessary hygiene will be provided before the use of glasses, and the researcher will ensure hand cleaning before entering the patient's room.
|
|
Placebo Comparator: Non-Virtual Reality Glasses Group
The plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded.
In addition, necessary variables will be recorded with the data collection form.
|
The plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded.
|
|
No Intervention: Control Group
Anxiety control will be done by the researcher (SU) for the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative Anxiety Level-1
Time Frame: 2 minutes before the intervention. Preoperative.
|
Visual Analogue Scale-Anxiety (VAS-A):This scale was used to evaluate patients' preoperative anxiety levels on the morning.
It consists of a horizontal line on the paper with scored from "0" for "experiencing no anxiety" on the left side to "10" for " experiencing too much anxiety" on the right side.It is also reported to be valid in evaluating preoperative anxiety of surgery patients.
The anxiety levels of a total of 96 patients were evaluated subjectively using the VAS-A scale.
Patients marked the level of anxiety they felt on a scale
|
2 minutes before the intervention. Preoperative.
|
|
Preoperative Stress Level-1
Time Frame: 2 minutes before the intervention. Preoperative.
|
This wearable device (smart bracelet) was used to evaluate the stress levels and heart rates of patients.
It utilizes a built-in sensor to estimate users' stress levels, providing a score ranging from 1 to 100, where 1 indicates minimal stress and 100 represents very high stress.
This estimation is derived from Heart Rate Variability (HRV) data.
The device applies a proprietary algorithm-referred to as a stress model-to interpret HRV fluctuations and classify the user's stress level accordingly.
The stress levels of a total of 96 patients were measured objectively with a smart bracelet.
|
2 minutes before the intervention. Preoperative.
|
|
Preoperative Heart Rate
Time Frame: 2 minutes before the intervention. Preoperative.
|
This wearable device was used to evaluate the stress levels and heart rates of patients.
It utilizes a built-in sensor to estimate users' stress levels, providing a score ranging from 1 to 100, where 1 indicates minimal stress and 100 represents very high stress.
This estimation is derived from Heart Rate Variability (HRV) data.
The device applies a proprietary algorithm-referred to as a stress model-to interpret HRV fluctuations and classify the user's stress level accordingly.
The heart rate levels of a total of 96 patients were measured objectively with a smart bracelet.
|
2 minutes before the intervention. Preoperative.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative Anxiety Level-2
Time Frame: Preoperative. immediately after intervention.
|
Visual Analogue Scale-Anxiety (VAS-A):This scale was used to evaluate patients' preoperative anxiety levels on the morning.
It consists of a horizontal line on the paper with scored from "0" for "experiencing no anxiety" on the left side to "10" for " experiencing too much anxiety" on the right side.It is also reported to be valid in evaluating preoperative anxiety of surgery patients.
The anxiety levels of a total of 96 patients were evaluated subjectively using the VAS-A scale.
Patients marked the level of anxiety they felt on a scale.
The patient was evaluated after watching the video.
The average video duration was 20 minutes.
|
Preoperative. immediately after intervention.
|
|
Preoperative Stress Level
Time Frame: Preoperative. immediately after intervention.
|
This wearable device was used to evaluate the stress levels and heart rates of patients.
It utilizes a built-in sensor to estimate users' stress levels, providing a score ranging from 1 to 100, where 1 indicates minimal stress and 100 represents very high stress.
This estimation is derived from Heart Rate Variability (HRV) data.
The device applies a proprietary algorithm-referred to as a stress model-to interpret HRV fluctuations and classify the user's stress level accordingly.
The patient was evaluated after watching the video.
The average video duration was 20 minutes.
The stress levels of a total of 96 patients were measured objectively with a smart bracelet.
|
Preoperative. immediately after intervention.
|
|
Preoperative Heart Rate
Time Frame: Preoperative. immediately after intervention.
|
This wearable device was used to evaluate the stress levels and heart rates of patients.
It utilizes a built-in sensor to estimate users' stress levels, providing a score ranging from 1 to 100, where 1 indicates minimal stress and 100 represents very high stress.
This estimation is derived from Heart Rate Variability (HRV) data.
The device applies a proprietary algorithm-referred to as a stress model-to interpret HRV fluctuations and classify the user's stress level accordingly.
The patient was evaluated after watching the video.
The average video duration was 20 minutes.
The heart rate levels of a total of 96 patients were measured objectively with a smart bracelet.
|
Preoperative. immediately after intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dogan Albayrak, Dr, Trakya University
Publications and helpful links
General Publications
- Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.
- Lin LY, Wang RH. Abdominal surgery, pain and anxiety: preoperative nursing intervention. J Adv Nurs. 2005 Aug;51(3):252-60. doi: 10.1111/j.1365-2648.2005.03502.x.
- Hendricks TM, Gutierrez CN, Stulak JM, Dearani JA, Miller JD. The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. Mayo Clin Proc. 2020 Jun;95(6):1148-1157. doi: 10.1016/j.mayocp.2020.02.032.
- Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Br J Anaesth. 2010 Mar;104(3):369-74. doi: 10.1093/bja/aeq002. Epub 2010 Feb 1.
- Herrera-Espineira C, Rodriguez del Aguila Mdel M, Rodriguez del Castillo M, Valdivia AF, Sanchez IR. Relationship between anxiety level of patients and their satisfaction with different aspects of healthcare. Health Policy. 2009 Jan;89(1):37-45. doi: 10.1016/j.healthpol.2008.04.012. Epub 2008 Jun 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Anxiety Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- TUTF-GOBAEK 2022/240
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
Clinical Trials on Watching video with virtual glasses
-
Akdeniz UniversityEnrolling by invitation
-
Selcuk UniversityCompletedAnxiety | Preterm Birth | Virtual Reality | Psychological Stress | Prenatal Attachment | PleasureTurkey
-
Aydin Adnan Menderes UniversityActive, not recruitingOperation Time | Music Listening | UreteroscopyTurkey
-
Dr. Hatice DönmezKaramanoğlu Mehmetbey UniversityCompletedPrimary Immunodeficiency Diseases (PID)Turkey (Türkiye)
-
TC Erciyes UniversityCompletedSurgery in ChildrenTurkey (Türkiye)
-
Aydin Adnan Menderes UniversityCompleted
-
Sahmyook UniversityCompletedHealthy Volunteers - Male and FemaleKorea, Republic of
-
Mersin UniversityCompletedPain, Acute | Anxiety and FearTurkey
-
Wake Forest University Health SciencesTerminatedDown Syndrome | Trisomy 21United States
-
Ondokuz Mayıs UniversityCompletedUrinary Retention PostoperativeTurkey (Türkiye)