Preoperative AnxietyNCT07016880
Anxiety, Physiological Parameters, Patient Satisfaction and VR in Gynecological Oncology Surgery
A study testing Virtual Reality Relaxation Session in people with Preoperative Anxiety and Women's Health, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Surgical procedures often cause significant anxiety in patients, particularly among women undergoing gynecological oncology surgeries. Preoperative anxiety is a common and preventable condition that can negatively affect both physiological parameters and the overall surgical experience. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preoperative Anxiety, Women's Health, Gynecological Cancers
- What is being tested?
- Virtual Reality Relaxation Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 15 Jul 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant must have a confirmed diagnosis of gynecological cancer.
- The participant must be aware of their gynecological cancer diagnosis.
- Participants must be 18 years of age or older.
- Verbal and written informed consent to participate in the study must be obtained.
- The participant must be able to communicate verbally and in writing in Turkish.
- No communication impairments (e.g., visual, auditory, or cognitive) should be present.
Show all 9Show fewer
- This must be the participant's first surgical intervention related to gynecological oncology.
- Eastern Cooperative Oncology Group (ECOG) Performance Status must not exceed 2.
- The planned surgical procedure must be a laparotomy.
Who cannot join
- History of recurrent gynecological cancer.
- Presence of vision problems that prevent the use of VR goggles, including participants who wear glasses or have uncorrected vision impairment.
- Presence of conditions such as migraines, vertigo, active nausea, vomiting, or frequent headaches.
- Sensitivity to motion sickness.
- Diagnosis of a psychiatric condition, whether under pharmacological or non-pharmacological treatment.
- Withdrawal of consent during the study.
- Removal of the virtual reality headset during the intervention.
- Development of any medical complications during the intervention period.
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
Hacettepe University
Ankara, 06100
Melike Sahingöz, PhD Student, +90 545 375 64 94, melike.shngz@gmail.com
Ozhan Ozdemir, Professor, +90 505 225 50 78, ozhan.ozdemir@saglik.gov.tr
About this study
Official title: The Effect of Virtual Reality Intervention on Preoperative Anxiety, Physiological Parameters and Patient Satisfaction in Women Scheduled for Gynecological Oncology Surgery: A Randomised Controlled Trial
Surgical procedures often cause significant anxiety in patients, particularly among women undergoing gynecological oncology surgeries. Preoperative anxiety is a common and preventable condition that can negatively affect both physiological parameters and the overall surgical experience. It may lead to increased heart rate, elevated blood pressure, respiratory distress, and psychological discomfort, increasing the risk of complications during and after surgery. Women facing gynecological cancer surgery often experience heightened anxiety due to concerns about survival, loss of reproductive organs, body image changes, and sexual health.
Virtual reality (VR) has emerged as a promising non-pharmacological approach for reducing preoperative anxiety. By immersing patients in a calming virtual environment that engages visual and auditory senses, VR helps promote relaxation, reduce stress, and enhance the patient's sense of control before surgery. It is safe, easy to implement, cost-effective, and does not have the side effects associated with medications.
Read more
Although VR has demonstrated effectiveness in reducing anxiety in various surgical contexts-including orthopedic, colorectal, and minor gynecological procedures-its impact in gynecologic oncology surgery remains underexplored. This randomized controlled trial aims to evaluate the effect of a VR intervention on preoperative anxiety, physiological parameters (blood pressure, heart rate, respiratory rate, oxygen saturation), and patient satisfaction in women scheduled for gynecologic oncology surgery.
Participants will be randomly assigned to either the intervention group (receiving VR) or the control group (receiving standard care). Anxiety and physiological measures will be evaluated before and after the respective intervention in both groups. Patient satisfaction will be assessed once, immediately after the intervention and before surgery.
The primary objective is to assess whether VR effectively reduces preoperative anxiety and stabilizes physiological indicators. The secondary objective is to evaluate patient satisfaction with the preoperative experience. This study will contribute to the evidence base for using VR as a nursing-led, non-invasive strategy to enhance surgical care in gynecologic oncology.
Read the detailed description
Preoperative anxiety is a common and preventable psychological condition that significantly affects surgical outcomes and patient well-being. Women undergoing gynecologic oncology surgery often face elevated levels of anxiety due to the severity of their diagnosis, potential loss of reproductive organs, and concerns related to survival, body image, and sexuality. These psychological stressors can lead to physiological changes such as increased blood pressure, heart rate, and respiratory distress, which in turn may complicate surgical procedures and recovery. Managing preoperative anxiety effectively is essential not only to minimize surgical risk but also to improve patient satisfaction and postoperative adaptation.
Pharmacological methods used to manage preoperative anxiety can carry risks such as side effects, drug interactions, and delayed postoperative recovery. For this reason, non-pharmacological interventions such as virtual reality (VR) have gained popularity in recent years. VR allows patients to be immersed in a multisensory virtual environment that helps distract their attention away from surgery-related fears and fosters relaxation. Studies in orthopedic, colorectal, and minor gynecologic procedures have shown that VR can reduce anxiety and improve physiological responses before surgery. However, limited evidence exists regarding its use in women undergoing gynecologic oncology surgery-a population that faces unique psychological and physical challenges.
This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of a virtual reality (VR) intervention in reducing preoperative anxiety and stabilizing physiological parameters in women scheduled for gynecologic oncology surgery via laparotomy. A total of 66 participants will be randomly assigned to either the intervention group (VR session) or the control group (standard care). In both groups, anxiety levels and physiological parameters (blood pressure, heart rate, respiratory rate, and oxygen saturation) will be assessed before and after the intervention. Patient satisfaction with preoperative care will be assessed only once, following the intervention or standard care session, immediately before surgery.
Eligibility criteria include adult women (≥18 years) with a confirmed diagnosis of gynecologic cancer who are aware of their diagnosis and scheduled for their first surgical intervention via laparotomy. Participants must have an ECOG Performance Status ≤2 and must not have any cognitive, visual, auditory, or psychiatric impairments that could interfere with communication or VR use. Exclusion criteria include recurrent cancer, motion sensitivity (e.g., vertigo or migraines), or any condition preventing the use of VR headsets.
The study aims to contribute new evidence supporting the use of VR as a nurse-led, low-risk, and effective non-pharmacological approach to improve preoperative experiences and perioperative outcomes in women facing gynecologic oncology surgery.
- Being tested
- Virtual Reality Relaxation Session
- Keywords
- Gynecological Surgery, Gynecological Oncology, Preoperative Anxiety, Preoperative Anxiety Management, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Relaxation SessionBehavioural
A 20 minute virtual reality session using visual and auditory stimuli for relaxation before surgery. Delivered via VR headset.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Participants in this group will receive a virtual reality intervention before surgery. Anxiety, physiological parameters, and satisfaction will be assessed both before and after the VR session. Receives: Behavioral: Virtual Reality Relaxation Session |
| Standard Care Group | No intervention | Participants in this group will receive standard preoperative care. The same measurements will be taken before and after standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Score
Change in anxiety levels as measured by the State-Trait Anxiety Inventory - State subscale (STAI-S), a 20-item scale ranging from 20 to 80. Higher scores indicate greater anxiety.
Measured: Immediately before and immediately after the intervention, on the day of surgery
Change in Systolic and Diastolic Blood Pressure
Change in systolic and diastolic blood pressure measured in mmHg, recorded using a calibrated automated monitor.
Measured: Immediately before and immediately after the intervention, on the day of surgery
Change in Heart Rate
Change in heart rate measured in beats per minute (bpm), recorded using standard physiological monitoring equipment.
Measured: Immediately before and immediately after the intervention, on the day of surgery
Change in Respiratory Rate
Change in respiratory rate recorded in breaths per minute using standard clinical observation.
Measured: Immediately before and immediately after the intervention, on the day of surgery
Change in Peripheral Oxygen Saturation
Change in oxygen saturation levels (%) measured using pulse oximetry.
Measured: Immediately before and immediately after the intervention, on the day of surgery
Secondary outcomes (1)
Preoperative Patient Satisfaction Score
Patient satisfaction will be assessed using a Visual Analog Scale (VAS), ranging from 0 to 10, where zero indicates 'Not satisfied at all' and 10 indicates 'Extremely satisfied.' Participants will be asked to rate their overall satisfaction with the care they received throughout the preoperative period.
Measured: Immediately after the intervention (same day, pre-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start15 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Uslu Sahan, Hacettepe University
- Investigators
- Fatma Uslu Sahan, Assoc Prof, Principal investigator, Hacettepe University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016880
- Sponsor's protocol ID
- 2024/93
- Status last verified
- Sep 2025
- First submitted
- 21 May 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koo CH, Park JW, Ryu JH, Han SH. The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Sep 29;9(10):3151. doi: 10.3390/jcm9103151.
PubMed 33003411Vogt L, Klasen M, Rossaint R, Goeretz U, Ebus P, Sopka S. Virtual Reality Tour to Reduce Perioperative Anxiety in an Operating Setting Before Anesthesia: Randomized Clinical Trial. J Med Internet Res. 2021 Sep 1;23(9):e28018. doi: 10.2196/28018.
PubMed 34252034Asiri S, Guilhermino M, Duff J. The effectiveness of using virtual reality technology for perioperative anxiety among adults undergoing elective surgery: a randomised controlled trial protocol. Trials. 2022 Dec 2;23(1):972. doi: 10.1186/s13063-022-06908-3.
PubMed 36461040Turrado V, Guzman Y, Jimenez-Lillo J, Villegas E, de Lacy FB, Blanch J, Balibrea JM, Lacy A. Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial. Surg Endosc. 2021 Jul;35(7):4042-4047. doi: 10.1007/s00464-021-08407-z. Epub 2021 Mar 8.
PubMed 33683433
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Intervention on Preoperative Anxiety, Physiological Parameters and Patient Satisfaction in Women Scheduled for Gynecological Oncology Surgery: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07016880
- Acronym / sponsor ID
- 2024/93
- Keywords
- Gynecological Surgery, Gynecological Oncology, Preoperative Anxiety, Preoperative Anxiety Management, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 12 Jun 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.
Surgical procedures often cause significant anxiety in patients, particularly among women undergoing gynecological oncology surgeries. Preoperative anxiety is a common and preventable condition that can negatively affect both physiological parameters and the overall surgical experience. It may lead to increased heart rate, elevated blood pressure, respiratory distress, and psychological discomfort, increasing the risk of complications during and after surgery. Women facing gynecological cancer surgery often experience heightened anxiety due to concerns about survival, loss of reproductive organs, body image changes, and sexual health.
Virtual reality (VR) has emerged as a promising non-pharmacological approach for reducing preoperative anxiety. By immersing patients in a calming virtual environment that engages visual and auditory senses, VR helps promote relaxation, reduce stress, and enhance the patient's sense of control before surgery. It is safe, easy to implement, cost-effective, and does not have the side effects associated with medications.
Although VR has demonstrated effectiveness in reducing anxiety in various surgical contexts-including orthopedic, colorectal, and minor gynecological procedures-its impact in gynecologic oncology surgery remains underexplored. This randomized controlled trial aims to evaluate the effect of a VR intervention on preoperative anxiety, physiological parameters (blood pressure, heart rate, respiratory rate, oxygen saturation), and patient satisfaction in women scheduled for gynecologic oncology surgery.
Participants will be randomly assigned to either the intervention group (receiving VR) or the control group (receiving standard care). Anxiety and physiological measures will be evaluated before and after the respective intervention in both groups. Patient satisfaction will be assessed once, immediately after the intervention and before surgery.
The primary objective is to assess whether VR effectively reduces preoperative anxiety and stabilizes physiological indicators. The secondary objective is to evaluate patient satisfaction with the preoperative experience. This study will contribute to the evidence base for using VR as a nursing-led, non-invasive strategy to enhance surgical care in gynecologic oncology.
Detailed description
Preoperative anxiety is a common and preventable psychological condition that significantly affects surgical outcomes and patient well-being. Women undergoing gynecologic oncology surgery often face elevated levels of anxiety due to the severity of their diagnosis, potential loss of reproductive organs, and concerns related to survival, body image, and sexuality. These psychological stressors can lead to physiological changes such as increased blood pressure, heart rate, and respiratory distress, which in turn may complicate surgical procedures and recovery. Managing preoperative anxiety effectively is essential not only to minimize surgical risk but also to improve patient satisfaction and postoperative adaptation.
Pharmacological methods used to manage preoperative anxiety can carry risks such as side effects, drug interactions, and delayed postoperative recovery. For this reason, non-pharmacological interventions such as virtual reality (VR) have gained popularity in recent years. VR allows patients to be immersed in a multisensory virtual environment that helps distract their attention away from surgery-related fears and fosters relaxation. Studies in orthopedic, colorectal, and minor gynecologic procedures have shown that VR can reduce anxiety and improve physiological responses before surgery. However, limited evidence exists regarding its use in women undergoing gynecologic oncology surgery-a population that faces unique psychological and physical challenges.
This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of a virtual reality (VR) intervention in reducing preoperative anxiety and stabilizing physiological parameters in women scheduled for gynecologic oncology surgery via laparotomy. A total of 66 participants will be randomly assigned to either the intervention group (VR session) or the control group (standard care). In both groups, anxiety levels and physiological parameters (blood pressure, heart rate, respiratory rate, and oxygen saturation) will be assessed before and after the intervention. Patient satisfaction with preoperative care will be assessed only once, following the intervention or standard care session, immediately before surgery.
Eligibility criteria include adult women (≥18 years) with a confirmed diagnosis of gynecologic cancer who are aware of their diagnosis and scheduled for their first surgical intervention via laparotomy. Participants must have an ECOG Performance Status ≤2 and must not have any cognitive, visual, auditory, or psychiatric impairments that could interfere with communication or VR use. Exclusion criteria include recurrent cancer, motion sensitivity (e.g., vertigo or migraines), or any condition preventing the use of VR headsets.
The study aims to contribute new evidence supporting the use of VR as a nurse-led, low-risk, and effective non-pharmacological approach to improve preoperative experiences and perioperative outcomes in women facing gynecologic oncology surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Virtual Reality Relaxation SessionParticipants in this group will receive a virtual reality intervention before surgery. Anxiety, physiological parameters, and satisfaction will be assessed both before and after the VR session. |
| Standard Care Group | No intervention | –Participants in this group will receive standard preoperative care. The same measurements will be taken before and after standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The participant must have a confirmed diagnosis of gynecological cancer.
- The participant must be aware of their gynecological cancer diagnosis.
- Participants must be 18 years of age or older.
- Verbal and written informed consent to participate in the study must be obtained.
- The participant must be able to communicate verbally and in writing in Turkish.
Key exclusion criteria (8 listed)
- History of recurrent gynecological cancer.
- Presence of vision problems that prevent the use of VR goggles, including participants who wear glasses or have uncorrected vision impairment.
- Presence of conditions such as migraines, vertigo, active nausea, vomiting, or frequent headaches.
- Sensitivity to motion sickness.
- Diagnosis of a psychiatric condition, whether under pharmacological or non-pharmacological treatment.
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 Reality Relaxation SessionA 20 minute virtual reality session using visual and auditory stimuli for relaxation before surgery. Delivered via VR headset. | Behavioural | Virtual Reality Group |
Primary outcome
Preoperative Anxiety Score
Time frame: Immediately before and immediately after the intervention, on the day of surgery
Change in anxiety levels as measured by the State-Trait Anxiety Inventory - State subscale (STAI-S), a 20-item scale ranging from 20 to 80. Higher scores indicate greater anxiety.
Change in Systolic and Diastolic Blood Pressure
Time frame: Immediately before and immediately after the intervention, on the day of surgery
Change in systolic and diastolic blood pressure measured in mmHg, recorded using a calibrated automated monitor.
Change in Heart Rate
Time frame: Immediately before and immediately after the intervention, on the day of surgery
Change in heart rate measured in beats per minute (bpm), recorded using standard physiological monitoring equipment.
Change in Respiratory Rate
Time frame: Immediately before and immediately after the intervention, on the day of surgery
Change in respiratory rate recorded in breaths per minute using standard clinical observation.
Change in Peripheral Oxygen Saturation
Time frame: Immediately before and immediately after the intervention, on the day of surgery
Change in oxygen saturation levels (%) measured using pulse oximetry.
1 secondary outcome
Preoperative Patient Satisfaction Score
Time frame: Immediately after the intervention (same day, pre-surgery)
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 10 Sep 2025.
- Results publication: PubMed 33003411Koo CH, Park JW, Ryu JH, Han SH. The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Sep 29;9(10):3151. doi: 10.3390/jcm9103151.
- Results publication: PubMed 34252034Vogt L, Klasen M, Rossaint R, Goeretz U, Ebus P, Sopka S. Virtual Reality Tour to Reduce Perioperative Anxiety in an Operating Setting Before Anesthesia: Randomized Clinical Trial. J Med Internet Res. 2021 Sep 1;23(9):e28018. doi: 10.2196/28018.
- Results publication: PubMed 36461040Asiri S, Guilhermino M, Duff J. The effectiveness of using virtual reality technology for perioperative anxiety among adults undergoing elective surgery: a randomised controlled trial protocol. Trials. 2022 Dec 2;23(1):972. doi: 10.1186/s13063-022-06908-3.
- Results publication: PubMed 33683433Turrado V, Guzman Y, Jimenez-Lillo J, Villegas E, de Lacy FB, Blanch J, Balibrea JM, Lacy A. Exposure to virtual reality as a tool to reduce peri-operative anxiety in patients undergoing colorectal cancer surgery: a single-center prospective randomized clinical trial. Surg Endosc. 2021 Jul;35(7):4042-4047. doi: 10.1007/s00464-021-08407-z. Epub 2021 Mar 8.
- Individual participant dataSharing planned: No
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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.
Fatma Uslu Sahan, Assoc Prof principal investigator
Hacettepe University Faculty of Nursing
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 Relaxation Session in people with Preoperative Anxiety and Women's Health, run by Hacettepe 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 8 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 10 Sep 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 Fatma Uslu Sahan, Assoc Prof (+90 534 224 59 80, fatma.uslu@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety Score (time frame: Immediately before and immediately after the intervention, on the day of surgery). The study lists 5 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 NCT07016880, which also lists 4 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 10 Sep 2025.