Anxiety, Physiological Parameters, Patient Satisfaction and VR in Gynecological Oncology Surgery

NCT07016880 | Recruiting

• 1 other identifier: 2024/93
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Anxiety; Women's Health; Gynecological Cancers; Gynecological Surgery

Keywords

Gynecological Surgery; Gynecological Oncology; Preoperative Anxiety; Preoperative Anxiety Management; Virtual Reality

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Immediately before and immediately after the intervention, on the day of surgery

Secondary Outcomes (1)

• Preoperative Patient Satisfaction Score

  Immediately after the intervention (same day, pre-surgery)

Study Arms (2)

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.

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.

Interventions

Virtual Reality Relaxation Session BEHAVIORAL

A 20 minute virtual reality session using visual and auditory stimuli for relaxation before surgery. Delivered via VR headset.

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 33003411 RESULT

• Vogt 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 RESULT

• Asiri 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 RESULT

• Turrado 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 RESULT

Study Officials

• Fatma Uslu Sahan, Assoc Prof

  Hacettepe University Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Uslu Sahan, Assoc Prof

CONTACT

+90 534 224 59 80; fatma.uslu@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 12, 2025
• Study Start: July 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 15, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)