NCT07337941

Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety

The Effects of Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Zonguldak Bulent Ecevit University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to examine the effects of menstrual cycle phase and a virtual reality (VR) intervention on preoperative anxiety in female patients scheduled for septorhinoplasty surgery.

Detailed description

This study was designed to evaluate the effects of menstrual cycle phases (follicular/luteal) and the use of virtual reality (VR) on preoperative anxiety levels and hemodynamic parameters in female patients scheduled for septorhinoplasty surgery. The study consisted of four groups: follicular phase with VR, follicular phase without VR, luteal phase with VR, and luteal phase without VR. All participants' preoperative anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI I-II) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). In the VR groups, heart rate and mean arterial pressure were recorded at baseline and at 5, 10, and 15 minutes during the video session. This study aims to determine whether VR, as a non-pharmacological method, is an effective tool for managing preoperative anxiety.

Conditions

• American Society of Anesthesiologists (ASA) I-II Risk Groups
• the Follicular (Days 1-12 From Last Menstruation) or Luteal (Days 20-24) Phase of the Menstrual Cycle
• Aged 18-55

Interventions

Type	Name	Description
OTHER	15-minute video providing a visual and auditory experience (Training Video)	Whether or not to watch a 15-minute video (Training Video) offering a visual and auditory experience, depending on the menstrual phase and group distribution.
OTHER	State-Trait Anxiety Inventory (STAI I-II)	Anxiety levels are scored as "(1) not at all, (2) a little, (3) a lot, and (4) completely" on the STAI-I, while the STAI-II options are (1) almost never, (2) sometimes, (3) a lot, and (4) almost always. There are two types of statements on the scales: direct statements express negative emotions, while reverse statements express positive emotions. Two separate total score weights are calculated for each direct and reverse statement. The total score for reverse statements is subtracted from the total score obtained for direct statements. A predetermined and constant value is added to this number. 50 is added as a constant value to the number obtained for the STAI-I. For the STAI-II, this value is 35. The final value is the individual's anxiety score. Scores from both scales theoretically range from 20 to 80. A high score indicates a high level of anxiety.
OTHER	The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment.	The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment.

Timeline

• Start date: 2021-11-10
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: Turkey (Türkiye)