AnxietyNCT05718661
The Effect of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients
A study testing Watching video with virtual glasses and watching video without virtual glasses in people with Anxiety, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Hospitalization, medical interventions to be performed, and uncertainties specific to surgical intervention create a certain level of anxiety in the patient. It is known that being in the hospital negatively affects the coping mechanisms of the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Watching video with virtual glasses and watching video without virtual glasses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Show all 9Show fewer
- Patients in isolation
- Patients with visual and/or auditory impairments
- Patients with neurological conditions such as vertigo
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients: A Double-Blinded Randomised Controlled Trial
Hospitalization, medical interventions to be performed, and uncertainties specific to surgical intervention create a certain level of anxiety in the patient. It is known that being in the hospital negatively affects the coping mechanisms of the patient. In the pre-surgical period, the nurse's practices that will facilitate the patient's coping with the situation and managing his anxiety have a positive effect on anxiety during and after surgery and on anxiety-related symptoms. For these reasons, it is aimed to determine the effect of virtual reality on pre-surgical anxiety in this study.The hypothesis of the study is that watching videos with virtual glasses will reduce preoperative anxiety.
Read the 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".
- Conditions
- Anxiety
- Being tested
- Watching video with virtual glasses, watching video without virtual glasses
- Keywords
- virtual reality, abdominal surgery, randomised controlled trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching video with virtual glassesBehavioural
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.
watching video without virtual glassesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | 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. Receives: Behavioral: Watching video with virtual glasses |
| Non-Virtual Reality Glasses Group | Placebo comparator | 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. Receives: Behavioral: watching video without virtual glasses |
| Control Group | No intervention | Anxiety control will be done by the researcher (SU) for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Level-1
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
Measured: 2 minutes before the intervention. Preoperative.
Preoperative Stress Level-1
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.
Measured: 2 minutes before the intervention. Preoperative.
Preoperative Heart Rate
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.
Measured: 2 minutes before the intervention. Preoperative.
Secondary outcomes (3)
Preoperative Anxiety Level-2
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.
Measured: Preoperative. immediately after intervention.
Preoperative Stress Level
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.
Measured: Preoperative. immediately after intervention.
Preoperative Heart Rate
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.
Measured: Preoperative. immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start30 Jan 2023
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research was designed using the experimental (intervention) research method. Under the same environment and conditions, to determine the effect on the same dependent variable, the intervention (experimental) group using virtual reality and the placebo group not using virtual reality (watching the same video with the naked eye), pre-test (measurement of the dependent variable before the intervention), post-test (dependent measurement of the variable after intervention). In addition, the group that was not interfered with will form the control group and a data collection form will be applied with an interval of 30 minutes.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Akbal, Trakya University
- Investigators
- Dogan Albayrak, Dr, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718661
- Sponsor's protocol ID
- TUTF-GOBAEK 2022/240
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared when requested from the authors.
Publications
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.
PubMed 18550203Jlala 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.
PubMed 20124283Lin 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.
PubMed 16033593Hendricks 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.
PubMed 32498771Mosso 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.
PubMed 19377147
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients: A Double-Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05718661
- Acronym / sponsor ID
- TUTF-GOBAEK 2022/240
- Conditions
- Anxiety
- Keywords
- virtual reality, abdominal surgery, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 8 Feb 2023 (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.
Hospitalization, medical interventions to be performed, and uncertainties specific to surgical intervention create a certain level of anxiety in the patient. It is known that being in the hospital negatively affects the coping mechanisms of the patient. In the pre-surgical period, the nurse's practices that will facilitate the patient's coping with the situation and managing his anxiety have a positive effect on anxiety during and after surgery and on anxiety-related symptoms. For these reasons, it is aimed to determine the effect of virtual reality on pre-surgical anxiety in this study.The hypothesis of the study is that watching videos with virtual glasses will reduce preoperative anxiety.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This research was designed using the experimental (intervention) research method. Under the same environment and conditions, to determine the effect on the same dependent variable, the intervention (experimental) group using virtual reality and the placebo group not using virtual reality (watching the same video with the naked eye), pre-test (measurement of the dependent variable before the intervention), post-test (dependent measurement of the variable after intervention). In addition, the group that was not interfered with will form the control group and a data collection form will be applied with an interval of 30 minutes.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | Behavioral: Watching video with virtual glassesThe 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. |
| Non-Virtual Reality Glasses Group | Placebo comparator | Behavioral: watching video without virtual glassesThe 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. |
| Control Group | No intervention | –Anxiety control will be done by the researcher (SU) for the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Watching video with virtual glassesUsing 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. | Behavioural | Virtual Reality Glasses Group |
| watching video without virtual glassesThe 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. | Behavioural | Non-Virtual Reality Glasses Group |
Primary outcome
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
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.
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.
3 secondary outcomes
Preoperative Anxiety Level-2
Time frame: Preoperative. immediately after intervention.
Preoperative Stress Level
Time frame: Preoperative. immediately after intervention.
Preoperative Heart Rate
Time frame: Preoperative. immediately after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 18550203Herrera-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.
- Background: PubMed 20124283Jlala 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.
- Background: PubMed 16033593Lin 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.
- Background: PubMed 32498771Hendricks 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.
- Background: PubMed 19377147Mosso 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.
- video that participants will watch with mobile virtual glasses - also video that participants will watch without virtual glassesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared when requested from the authors.
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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. This study is not recruiting at the moment.
Dogan Albayrak, Dr principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watching video with virtual glasses and watching video without virtual glasses in people with Anxiety, run by Trakya 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 9 inclusion and 0 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: finished, as of the sponsor's last update on 23 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety Level-1 (time frame: 2 minutes before the intervention. Preoperative.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05718661, which also lists 5 linked publications.
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 23 Jan 2026.