Virtual reality to reduce anxiety and improve vital signs and satisfaction for women having gynecologic cancer surgery
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
NA · Hacettepe University · NCT07016880
This study will try a short virtual reality relaxation session before open gynecologic cancer surgery to reduce anxiety and help stabilize heart rate, blood pressure, and patient satisfaction.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hacettepe University (other) |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07016880 on ClinicalTrials.gov |
What this trial studies
This interventional study delivers a brief virtual reality relaxation session to adult women preparing for laparotomy for gynecologic cancer and records anxiety levels, physiological parameters (heart rate, blood pressure, respiration), and patient satisfaction. Participants must be Turkish-speaking, able to use VR goggles, and undergoing their first gynecologic oncology surgery with ECOG performance status ≤2. Patients with recurrent disease, vision problems preventing VR use, or vestibular/neurologic conditions are excluded. Outcomes compare preoperative measures and immediate perioperative physiological responses and satisfaction to determine VR's practical effects in this population.
Who should consider this trial
Good fit: Adult Turkish-speaking women with a confirmed first-time diagnosis of gynecologic cancer scheduled for laparotomy and with ECOG performance status 0–2 who can use VR goggles are ideal candidates.
Not a fit: Patients with recurrent gynecologic cancer, uncorrected vision or inability to wear VR goggles, or conditions like migraines, vertigo, severe nausea, or an inability to communicate in Turkish are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, VR could lower preoperative anxiety, help normalize vital signs, and improve the overall surgical experience without adding medications.
How similar studies have performed: Previous work in orthopedic, colorectal, and minor gynecologic procedures has shown VR can reduce preoperative anxiety and improve physiologic responses, but evidence specifically for major gynecologic oncology surgery is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ankara
- Hacettepe University — Ankara, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Fatma Uslu Sahan, Assoc Prof — Hacettepe University Faculty of Nursing
- Study coordinator: Fatma Uslu Sahan, Assoc Prof
- Email: fatma.uslu@hacettepe.edu.tr
- Phone: +90 534 224 59 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preoperative Anxiety, Women', s Health, Gynecological Cancers, Gynecological Surgery, Gynecological Oncology, Preoperative Anxiety Management, Virtual Reality