Preoperative PatientsNCT06830330
Effect of Virtual Reality Application on Anxiety and Fear in Patients
A study testing Virtual reality in people with Preoperative Patients and Patients Undergoing Abdominal Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Patients, Patients Undergoing Abdominal Surgery
- What is being tested?
- Virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who use glasses
- Patients with an ASA score above 3
- Patients with vertigo and motion sickness
- Patients with known psychiatric or behavioral diagnoses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Balcali Hospital Health Application and Research Center
Adana, Sarıçam
Nursevim A Research assistant, +905458504330, nursevimaydingulu@gmail.com
Nursevim A Research assistant
About this study
Official title: Effect of Virtual Reality Application on Anxiety and Fear in Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Study
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:
Read more
- 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
Read the 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.
Surgical Fear Scale: It was developed by Theunissen and colleagues in 2014 to determine the level of fear experienced by patients scheduled for surgical treatment due to short- and long-term outcomes of the surgical procedure. The Turkish validity and reliability of the scale was performed by Bağdigen and Karamanözlü in 2018. The scale, consisting of 8 items, is scored between 0 and 10. A score of 0 for each item means "I am not afraid at all", while a score of 10 means "I am very afraid". The scale consists of two sub-dimensions regarding the source of fear. The first 4 items of the scale measure the fear of short-term outcomes of surgery, while the last 4 items measure the fear of long-term outcomes. The lowest score that can be obtained from the sub-dimensions in the scale is 0, and the highest score is 40. The sum of the two sub-dimension scores gives the total score of the scale. The lowest total score of the scale is 0, and the highest total score is 80. A high score indicates that the fear of surgery is high.
State and Trait Anxiety Inventory (STAI-I): The state anxiety scale shows how individuals feel at a certain moment and under a certain condition, while the trait anxiety scale shows how they feel in general. The scale was developed by Spielberger in 1970. The scale, which was adapted to Turkish by Öner and Le Compte in 1983, consists of a total of 40 items. The first 20 items of the scale examine the individual's state anxiety, and the last 20 items examine the individual's trait anxiety, totaling 40 items. Each item is scored on a 4-point Likert type. In the state anxiety scale, 1 point means "not at all", 2 means "a little", 3 means "a lot of the time", and 4 points means "completely". Scores in the trait anxiety scale are as follows; 1 means "almost never", 2 means "sometimes", 3 means "a lot of the time", 4 means "almost always". A total score of 20-80 can be obtained from both scales. A high score indicates a high level of anxiety. Two separate keys are prepared to determine the total weights of direct and reversed expressions. The total weighted score of the reversed expressions is subtracted from the total weight score of the direct expressions. A previously determined and unchanging value is added to the number found. This unchanging value is 50 for state anxiety and 35 for trait anxiety. The resulting value shows the individual's anxiety score. The total score obtained from both scales varies between 20 and 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.
2.723 / 5.000 Data Collection Process During the data collection process, the researchers met with patients who met the inclusion criteria in the clinic the night before the surgery and obtained written consent to participate in the study. A total of 84 patients were evaluated for research eligibility. Of these patients, 23 were excluded from the study because they did not meet the inclusion criteria, and 5 were excluded because they did not accept participation. During the preliminary interview (Time 1), written consent to participate in the study was obtained from patients who met the inclusion criteria. Patients who accepted participation were administered the patient identification form and trait anxiety scale. They were also informed that they would be interviewed again the next morning before surgery. Patients who accepted participation were assigned to one of the study groups according to the determined randomization method on the morning of the surgery (Time 2). Randomization of the patients was performed according to the study days. Data from the experimental group were collected on three days of the week, and data from the control group were collected on two days. During the data collection process, the days determined for the experimental group and the control group were randomized each week. Thus, patients were blinded in terms of the applications in the study groups. The patient identification form, trait anxiety scale, state anxiety scale and surgical fear scale were first administered to patients in the preoperative waiting unit.
Then, the patients in the experimental group were shown videos containing natural scenes with the help of VR glasses (Oculus Quest 2, 64GB) in the patient bed. This application was used to divert the attention of patients experiencing negative emotions just before surgery. The video session begins with the introduction of the virtual reality glasses. A motionless virtual area is determined at the point where the patient's stretcher is located. The glasses are placed on the patient's head and both hands of the patient are trained to use the remote control. The video content is selected and started according to the patient's preference. The video sessions last approximately 10 minutes. Patient-specific preparation procedures (opening vascular access, taking vital signs, premedication, informing the patient, etc.) were performed for the patients in the control group. The state anxiety scale and surgical fear scale were repeated for both groups 15 minutes after the procedures determined for the application and control groups were applied (Time 3).
6 of the patients in the experimental group and 2 of the patients in the control group were excluded from the study because the posttest could not be applied when they were taken into surgery. In addition, one patient experienced dizziness and the video session was interrupted and the patient was excluded from the study. The data collection process was terminated when the number determined by power analysis was reached. The study was completed with 24 experimental and 23 control patients.
- Being tested
- Virtual reality
- Keywords
- preoperative anxiety, surgical fear, virtual reality, Anxiety State
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
Patients in the experimental group were shown videos of natural landscapes with VR glasses in their beds. This application was used to distract patients who were experiencing negative emotions just before surgery. The video session begins with the introduction of the virtual reality glasses. A motionless virtual area is determined at the point where the patient's stretcher is located. The glasses are placed on the patient's head and both hands of the patient are trained to use the remote control. Video content is selected and started according to the patient's preference. Video sessions last approximately 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Virtual Reality Group Receives: Behavioral: Virtual reality |
| Control Group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Level Change
The effect of virtual reality intervention on preoperative anxiety level is safely evaluated.
Measured: The state anxiety scale were applied to the patients 15 minutes after they watched the video with virtual reality glasses.
Secondary outcomes (1)
Change in fear level related to surgery
The effect of virtual reality intervention on surgical fear level is safely evaluated.
Measured: The surgical fear scale were applied to the patients 15 minutes after they watched the video with virtual reality glasses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start20 Aug 2024
- Primary completion5 Feb 2025
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative PatientsStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted as a randomized, controlled, interventional study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursevim Aydıngülü, Cukurova University
- Investigators
- Sevban A Proffessor doctor, Study director, Çukurova University, Faculty of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830330
- Sponsor's protocol ID
- Sağlık Bilimleri Fakültesi
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethics committee approval was obtained for the study to be conducted. For this reason, participant data cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Application on Anxiety and Fear in Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06830330
- Acronym / sponsor ID
- Sağlık Bilimleri Fakültesi
- Keywords
- preoperative anxiety, surgical fear, virtual reality, Anxiety State
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Surgical Fear Scale: It was developed by Theunissen and colleagues in 2014 to determine the level of fear experienced by patients scheduled for surgical treatment due to short- and long-term outcomes of the surgical procedure. The Turkish validity and reliability of the scale was performed by Bağdigen and Karamanözlü in 2018. The scale, consisting of 8 items, is scored between 0 and 10. A score of 0 for each item means "I am not afraid at all", while a score of 10 means "I am very afraid". The scale consists of two sub-dimensions regarding the source of fear. The first 4 items of the scale measure the fear of short-term outcomes of surgery, while the last 4 items measure the fear of long-term outcomes. The lowest score that can be obtained from the sub-dimensions in the scale is 0, and the highest score is 40. The sum of the two sub-dimension scores gives the total score of the scale. The lowest total score of the scale is 0, and the highest total score is 80. A high score indicates that the fear of surgery is high.
State and Trait Anxiety Inventory (STAI-I): The state anxiety scale shows how individuals feel at a certain moment and under a certain condition, while the trait anxiety scale shows how they feel in general. The scale was developed by Spielberger in 1970. The scale, which was adapted to Turkish by Öner and Le Compte in 1983, consists of a total of 40 items. The first 20 items of the scale examine the individual's state anxiety, and the last 20 items examine the individual's trait anxiety, totaling 40 items. Each item is scored on a 4-point Likert type. In the state anxiety scale, 1 point means "not at all", 2 means "a little", 3 means "a lot of the time", and 4 points means "completely". Scores in the trait anxiety scale are as follows; 1 means "almost never", 2 means "sometimes", 3 means "a lot of the time", 4 means "almost always". A total score of 20-80 can be obtained from both scales. A high score indicates a high level of anxiety. Two separate keys are prepared to determine the total weights of direct and reversed expressions. The total weighted score of the reversed expressions is subtracted from the total weight score of the direct expressions. A previously determined and unchanging value is added to the number found. This unchanging value is 50 for state anxiety and 35 for trait anxiety. The resulting value shows the individual's anxiety score. The total score obtained from both scales varies between 20 and 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.
2.723 / 5.000 Data Collection Process During the data collection process, the researchers met with patients who met the inclusion criteria in the clinic the night before the surgery and obtained written consent to participate in the study. A total of 84 patients were evaluated for research eligibility. Of these patients, 23 were excluded from the study because they did not meet the inclusion criteria, and 5 were excluded because they did not accept participation. During the preliminary interview (Time 1), written consent to participate in the study was obtained from patients who met the inclusion criteria. Patients who accepted participation were administered the patient identification form and trait anxiety scale. They were also informed that they would be interviewed again the next morning before surgery. Patients who accepted participation were assigned to one of the study groups according to the determined randomization method on the morning of the surgery (Time 2). Randomization of the patients was performed according to the study days. Data from the experimental group were collected on three days of the week, and data from the control group were collected on two days. During the data collection process, the days determined for the experimental group and the control group were randomized each week. Thus, patients were blinded in terms of the applications in the study groups. The patient identification form, trait anxiety scale, state anxiety scale and surgical fear scale were first administered to patients in the preoperative waiting unit.
Then, the patients in the experimental group were shown videos containing natural scenes with the help of VR glasses (Oculus Quest 2, 64GB) in the patient bed. This application was used to divert the attention of patients experiencing negative emotions just before surgery. The video session begins with the introduction of the virtual reality glasses. A motionless virtual area is determined at the point where the patient's stretcher is located. The glasses are placed on the patient's head and both hands of the patient are trained to use the remote control. The video content is selected and started according to the patient's preference. The video sessions last approximately 10 minutes. Patient-specific preparation procedures (opening vascular access, taking vital signs, premedication, informing the patient, etc.) were performed for the patients in the control group. The state anxiety scale and surgical fear scale were repeated for both groups 15 minutes after the procedures determined for the application and control groups were applied (Time 3).
6 of the patients in the experimental group and 2 of the patients in the control group were excluded from the study because the posttest could not be applied when they were taken into surgery. In addition, one patient experienced dizziness and the video session was interrupted and the patient was excluded from the study. The data collection process was terminated when the number determined by power analysis was reached. The study was completed with 24 experimental and 23 control patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was conducted as a randomized, controlled, interventional study.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Virtual realityVirtual Reality Group |
| Control Group | No intervention | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patients who use glasses
- Patients with an ASA score above 3
- Patients with vertigo and motion sickness
- Patients with known psychiatric or behavioral diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityPatients in the experimental group were shown videos of natural landscapes with VR glasses in their beds. This application was used to distract patients who were experiencing negative emotions just before surgery. The video session begins with the introduction of the virtual reality glasses. A motionless virtual area is determined at the point where the patient's stretcher is located. The glasses are placed on the patient's head and both hands of the patient are trained to use the remote control. Video content is selected and started according to the patient's preference. Video sessions last approximately 10 minutes. | Behavioural | Virtual Reality Group |
Primary outcome
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.
1 secondary outcome
Change in fear level related to surgery
Time frame: The surgical fear scale were applied to the patients 15 minutes after they watched the video with virtual reality glasses.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No. Ethics committee approval was obtained for the study to be conducted. For this reason, participant data cannot be shared.
Related trials for Preoperative Patients
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
RecruitingPhase 2
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
High-risk Localized Prostate Cancer
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sevban A Proffessor doctor study director
Çukurova University, Faculty of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Preoperative Patients and Patients Undergoing Abdominal Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nursevim A research assistant (+905458504330, nursevimaydingulu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.