Clinical trial · Interventional
Anxiety, Physiological Parameters, Patient Satisfaction and VR in Gynecological Oncology 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecological Cancers | — | UNRESOLVED | — |
| Gynecological Surgery | — | UNRESOLVED | — |
| Preoperative Anxiety | — | UNRESOLVED | — |
| Women's Health | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Virtual Reality Relaxation Session | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Virtual Reality Group
- description
- 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.
- interventionNames
- Behavioral: Virtual Reality Relaxation Session
- type
- NO_INTERVENTION
- label
- Standard Care Group
- description
- Participants in this group will receive standard preoperative care. The same measurements will be taken before and after standard care.
Primary outcomes (5)
- measure
- Preoperative Anxiety Score
- timeFrame
- Immediately before and immediately after the intervention, on the day of surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- RESULTKoo 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. PMID 33003411
- RESULTVogt 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. PMID 34252034
- RESULTAsiri 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. PMID 36461040
- RESULTTurrado 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. PMID 33683433