Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety

Zonguldak Bulent Ecevit University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07337941

2021/21 VR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 4 patient groups, including a placebo group

Gorup 2: Luteal Phase + No VR

Placebo Comparator group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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 group

Description:

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

Treatment:

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

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