American Society of Anesthesiologists (ASA) I-II Risk GroupsNCT07337941
Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety
A study testing 15-minute video providing a visual and auditory experience (Training Video), State-Trait Anxiety Inventory (STAI I-II) and The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment. in people with American Society of Anesthesiologists (ASA) I-II Risk Groups and the Follicular (Days 1-12 From Last Menstruation) or Luteal (Days 20-24) Phase of the Menstrual Cycle, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- 15-minute video providing a visual and auditory experience (Training Video), State-Trait Anxiety Inventory (STAI I-II) and The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2021to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 11Show fewer
- epilepsy,
- claustrophobia,
- alcohol-substance dependence,
- blindness or deafness,
- revision septorhinoplasty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of 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.
Read the 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
- Being tested
- 15-minute video providing a visual and auditory experience (Training Video), State-Trait Anxiety Inventory (STAI I-II), The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment.
- Keywords
- Virtual Reality, Preoperative Anxiety, Menstrual Cycle Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Other: 15-minute video providing a visual and auditory experience (Training Video); Other: State-Trait Anxiety Inventory (STAI I-II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amsterdam Preoperative Anxiety and Information Scale (APAIS) Score
Measured: Preoperative (before VR or baseline)
State-Trait Anxiety Inventory (STAI-I/II) Score
Measured: Preoperative and Post-Intervention (after 15-minute video or control period)
Secondary outcomes (1)
Heart Rate
Measured: At baseline, and at 5, 10, and 15 minutes during video viewing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start10 Nov 2021
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for American Society of Anesthesiologists (ASA) I-II Risk GroupsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Küçükosman, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337941
- Sponsor's protocol ID
- 2021/21 VR
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety
- ClinicalTrials.gov ID
- NCT07337941
- Acronym / sponsor ID
- 2021/21 VR
- 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
- Keywords
- Virtual Reality, Preoperative Anxiety, Menstrual Cycle Phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gorup 2: Luteal Phase + No VR | Placebo comparator | 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.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 3: Follicular Phase + Virtual Reality (VR) | Active comparator | Other: 15-minute video providing a visual and auditory experience (Training Video), Other: State-Trait Anxiety Inventory (STAI I-II)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 4: Follicular Phase + No VR | Placebo comparator | 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.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 1:Luteal Phase+ Virtual Reality (VR) | Active comparator | Other: 15-minute video providing a visual and auditory experience (Training Video), Other: State-Trait Anxiety Inventory (STAI I-II)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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- if they did not speak Turkish
- in days 13-19 of their menstrual cycle,
- menstrual irregularities,
- undergone hysterectomy or bilateral salpingo-oophorectomy,
- drug allergies,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group 1:Luteal Phase+ Virtual Reality (VR), Group 3: Follicular Phase + Virtual Reality (VR) |
| 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. | Other | 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.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 | Gorup 2: Luteal Phase + No VR, Group 4: Follicular Phase + No VR |
Primary outcome
Amsterdam Preoperative Anxiety and Information Scale (APAIS) Score
Time frame: Preoperative (before VR or baseline)
State-Trait Anxiety Inventory (STAI-I/II) Score
Time frame: Preoperative and Post-Intervention (after 15-minute video or control period)
1 secondary outcome
Heart Rate
Time frame: At baseline, and at 5, 10, and 15 minutes during video viewing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15-minute video providing a visual and auditory experience (Training Video), State-Trait Anxiety Inventory (STAI I-II) and The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment. in people with American Society of Anesthesiologists (ASA) I-II Risk Groups and the Follicular (Days 1-12 From Last Menstruation) or Luteal (Days 20-24) Phase of the Menstrual Cycle, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amsterdam Preoperative Anxiety and Information Scale (APAIS) Score (time frame: Preoperative (before VR or baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.