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Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07337941
Enrollment
170
Registered
2026-01-13
Start date
2021-11-10
Completion date
2022-02-10
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aged 18-55, 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

Keywords

Virtual Reality, Preoperative Anxiety, Menstrual Cycle Phase

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.

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.

Interventions

OTHER15-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.

OTHERState-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.

OTHERThe 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.

Sponsors

Zonguldak Bulent Ecevit University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Amsterdam Preoperative Anxiety and Information Scale (APAIS) ScorePreoperative (before VR or baseline)
State-Trait Anxiety Inventory (STAI-I/II) ScorePreoperative and Post-Intervention (after 15-minute video or control period)

Secondary

MeasureTime frame
Heart RateAt baseline, and at 5, 10, and 15 minutes during video viewing

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026