Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety

NCT07337941 | Completed

• 1 other identifier: 2021/21 VR
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Virtual Reality; Preoperative Anxiety; Menstrual Cycle Phase

Outcome Measures

Primary Outcomes (2)

• Amsterdam Preoperative Anxiety and Information Scale (APAIS) Score

  Preoperative (before VR or baseline)

• State-Trait Anxiety Inventory (STAI-I/II) Score

  Preoperative and Post-Intervention (after 15-minute video or control period)

Secondary Outcomes (1)

• Heart Rate

  At baseline, and at 5, 10, and 15 minutes during video viewing

Study Arms (4)

Gorup 2: Luteal Phase + No VR

PLACEBO COMPARATOR

The 15-minute immersive virtual reality video, which offered both visual and auditory stimuli, was not shown. In the preoperative period, heart rate and mean arterial pressure values were recorded at baseline, and at 5, 10, and 15 minutes over a 15-minute period. Participants were asked to complete the STAI I-II anxiety scales only once.

Other: State-Trait Anxiety Inventory (STAI I-II); 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.

Group 3: Follicular Phase + Virtual Reality (VR)

ACTIVE COMPARATOR

15-minute immersive virtual reality video providing both visual and auditory stimuli .Baseline and 5th, 10th, and 15th minute heart rate and mean arterial pressure values were recorded during the viewing of the video. After the video, the headset was removed, and the patients were asked to complete STAI I-II again.

Other: 15-minute video providing a visual and auditory experience (Training Video); Other: State-Trait Anxiety Inventory (STAI I-II)

Group 4: Follicular Phase + No VR

PLACEBO COMPARATOR

The 15-minute immersive virtual reality video, which offered both visual and auditory stimuli, was not shown. In the preoperative period, heart rate and mean arterial pressure values were recorded at baseline, and at 5, 10, and 15 minutes over a 15-minute period. Participants were asked to complete the STAI I-II anxiety scales only once.

Other: State-Trait Anxiety Inventory (STAI I-II); 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.

Group 1:Luteal Phase+ Virtual Reality (VR)

ACTIVE COMPARATOR

15-minute immersive virtual reality video providing both visual and auditory stimuli .Baseline and 5th, 10th, and 15th minute heart rate and mean arterial pressure values were recorded during the viewing of the video. After the video, the headset was removed, and the patients were asked to complete STAI I-II agai

Other: 15-minute video providing a visual and auditory experience (Training Video); Other: State-Trait Anxiety Inventory (STAI I-II)

Interventions

15-minute video providing a visual and auditory experience (Training Video) OTHER

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.

Group 1:Luteal Phase+ Virtual Reality (VR); Group 3: Follicular Phase + Virtual Reality (VR)

State-Trait Anxiety Inventory (STAI I-II) OTHER

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.

Gorup 2: Luteal Phase + No VR; Group 1:Luteal Phase+ Virtual Reality (VR); Group 3: Follicular Phase + Virtual Reality (VR); Group 4: Follicular Phase + No VR

The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment. 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.

Gorup 2: Luteal Phase + No VR; Group 4: Follicular Phase + No VR

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) I-II risk groups,
• scheduled for elective septorhinoplasty,
• either the follicular (days 1-12 from last menstruation) or luteal (days 20-24) phase of the menstrual cycle

You may not qualify if:

• if they did not speak Turkish
• in days 13-19 of their menstrual cycle,
• menstrual irregularities,
• undergone hysterectomy or bilateral salpingo-oophorectomy,
• drug allergies,
• psychiatric or cognitive dysfunction,
• epilepsy,
• claustrophobia,
• alcohol-substance dependence,
• blindness or deafness,
• revision septorhinoplasty.

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Gamze Küçükosman

Zonguldak, 67600, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 13, 2026
• Study Start: November 10, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

TU (1)