NCT07016880 Anxiety, Physiological Parameters, Patient Satisfaction and VR in Gynecological Oncology Surgery
| NCT ID | NCT07016880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hacettepe University |
| Condition | Preoperative Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2025-07-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
Contact & Investigator
Fatma Uslu Sahan, Assoc Prof
PRINCIPAL INVESTIGATOR
Hacettepe University Faculty of Nursing
Frequently Asked Questions
Who can join the NCT07016880 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preoperative Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07016880 currently recruiting?
Yes, NCT07016880 is actively recruiting participants. Contact the research team at fatma.uslu@hacettepe.edu.tr for enrollment information.
Where is the NCT07016880 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07016880 clinical trial?
NCT07016880 is sponsored by Hacettepe University. The principal investigator is Fatma Uslu Sahan, Assoc Prof at Hacettepe University Faculty of Nursing. The trial plans to enroll 66 participants.
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