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Completed

NCT Number: NCT07337941

Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety

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.

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Key information

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

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gamze Küçükosman

Zonguldak, 67600, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Amsterdam Preoperative Anxiety and Information Scale (APAIS) Score

    Time frame: Preoperative (before VR or baseline)

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

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

Secondary outcomes

  1. Heart Rate

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

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.