Anxiety, Physiological Parameters, Patient Satisfaction and VR in Gynecological Oncology Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHacettepe University
About this 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.
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Relaxation Session
BehavioralA 20 minute virtual reality session using visual and auditory stimuli for relaxation before surgery. Delivered via VR headset.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality GroupExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately before and immediately after the intervention, on the day of surgery2
Change in Systolic and Diastolic Blood Pressure
Change in systolic and diastolic blood pressure measured in mmHg, recorded using a calibrated automated monitor.
Time frame
Immediately before and immediately after the intervention, on the day of surgery3
Change in Heart Rate
Change in heart rate measured in beats per minute (bpm), recorded using standard physiological monitoring equipment.
Time frame
Immediately before and immediately after the intervention, on the day of surgery4
Change in Respiratory Rate
Change in respiratory rate recorded in breaths per minute using standard clinical observation.
Time frame
Immediately before and immediately after the intervention, on the day of surgerySecondary 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.
Time frame
Immediately after the intervention (same day, pre-surgery)Sponsors and contacts
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Source ClinicalTrials.gov