Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety

NCT ID: NCT07337941

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2022-02-10

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Gorup 2: Luteal Phase + No VR

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.

Group Type: PLACEBO_COMPARATOR

State-Trait Anxiety Inventory (STAI I-II)

Intervention Type: 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.

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

Intervention Type: 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.

Group 4: Follicular Phase + No VR

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.

Group Type: PLACEBO_COMPARATOR

State-Trait Anxiety Inventory (STAI I-II)

Intervention Type: 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.

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zonguldak Bulent Ecevit University

OTHER

Sponsor Role: lead

Responsible Party

Gamze Küçükosman

Principal Investigator, Department of Anesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gamze Küçükosman

Zonguldak, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021/21 VR

Identifier Type: -

Identifier Source: org_study_id