AnxietyNCT06680141
The Effect of Virtual Reality Glasses Used Before Cesarean Section
A study testing Virtual reality glasses in people with Anxiety, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Will undergo a cesarean section for the first time,
- Are over the age of 18,
- Have no diagnosed mental illness,
- Have no diagnosed physical illness in themselves or their baby,
- Volunteer to participate in the study
Who cannot join
- Have previously undergone a cesarean section,
- Are under the age of 18,
- Have a diagnosed mental illness,
- Have a diagnosed physical illness in themselves or their baby, Do not volunteer to participate in the study. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ondokuz Mayis University
Samsun, 55200
Sümeyye BAL, Ph.D., 0(362)3121919 ext. 6424
About this study
Official title: The Effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety
The aim of this study is to determine the effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety
Read the detailed description
Hypotheses 01; there was no difference between the Surgical Fear and Anxiety score of the Virtual Reality Glasses group and the control group.
The study will be carried out in two different groups. The practice will start with meeting the women whom will go to cesarean section in the hospital. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Virtual Reality Glasses Group; the intervention will be given glasses before the surgery and will be shown a video (30 minutes) of the 9-month fetal development process. Among the women who were admitted for a planned caesarean section, those who met the criteria would first be given the Informed Consent Form and a data collection form including sociodemographic characteristics, surgical fear scale, Spielberg State-Trait Anxiety Scale, and then randomization would be applied.
control group; the first surgical fear scale, anxiety scores will be recorded. After cesarean section anxiety scores will be recorded.
- Conditions
- Anxiety
- Being tested
- Virtual reality glasses
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glassesOther
Also called control group
control group
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses | Experimental | Among the women who have been admitted for a planned caesarean section, the Informed Consent Form and the Data Collection Form including Sociodemographic Characteristics, Surgical Fear Scale, Spielberg State-Trait Anxiety Scale will be applied to the women who meet the criteria and randomization will be applied. After randomization, they will be divided into a virtual reality glasses application group and a control group. All women will be applied the Spielberg State-Trait Anxiety Scale and Surgical Fear Scale in the patient room before and after the SGG application. The experimental group will be shown a video (30 minutes) of the 9-month fetal development process, with glasses on before going to surgery. Receives: Other: Virtual reality glasses |
| control | No intervention | Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention will perform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberger State Anxiety Scale
The inventory was developed by Spielberger, Gorsuch, and Lushene in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety. The Cronbach's a for the STAI ranges from 0.83 to 0.87. It will be applied half an hour before the surgery.
Measured: 30 minutes
Surgical Fear Scale (SFS):
The scale was developed by Theunissen et al. (2014) and its validity and reliability for use in Turkey were established by Bağdigen and Karaman Özlü (2018). The scale consists of 8 items in an 11-point Likert format, scored between 0 and 10. It is divided into two subscales, each containing 4 items, measuring short-term and long-term fears related to surgery.
Items 1-4 assess fear regarding short-term outcomes of surgery, while items 5-8 evaluate fear concerning long-term outcomes. Each item is rated from "0: not afraid at all" to "10: extremely afraid." A higher total score, with a maximum of 26 points, indicates a greater level of fear. In the validity and reliability study, the Cronbach's alpha coefficient for the total score was found to be 0.93.It will be applied half an hour before the surgery.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye BAL, Ondokuz Mayıs University
- Investigators
- Emine KOÇ, Asst.Prof, Study chair, Ondokuz Mayıs UniversityNazlı Baltacı, Asst.Prof, Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680141
- Sponsor's protocol ID
- 2022/260
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety
- ClinicalTrials.gov ID
- NCT06680141
- Acronym / sponsor ID
- 2022/260
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 8 Nov 2024 (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.
The aim of this study is to determine the effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety
Detailed description
Hypotheses 01; there was no difference between the Surgical Fear and Anxiety score of the Virtual Reality Glasses group and the control group.
The study will be carried out in two different groups. The practice will start with meeting the women whom will go to cesarean section in the hospital. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Virtual Reality Glasses Group; the intervention will be given glasses before the surgery and will be shown a video (30 minutes) of the 9-month fetal development process. Among the women who were admitted for a planned caesarean section, those who met the criteria would first be given the Informed Consent Form and a data collection form including sociodemographic characteristics, surgical fear scale, Spielberg State-Trait Anxiety Scale, and then randomization would be applied.
control group; the first surgical fear scale, anxiety scores will be recorded. After cesarean section anxiety scores will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses | Experimental | Other: Virtual reality glassesAmong the women who have been admitted for a planned caesarean section, the Informed Consent Form and the Data Collection Form including Sociodemographic Characteristics, Surgical Fear Scale, Spielberg State-Trait Anxiety Scale will be applied to the women who meet the criteria and randomization will be applied. After randomization, they will be divided into a virtual reality glasses application group and a control group. All women will be applied the Spielberg State-Trait Anxiety Scale and Surgical Fear Scale in the patient room before and after the SGG application. The experimental group will be shown a video (30 minutes) of the 9-month fetal development process, with glasses on before going to surgery. |
| control | No intervention | –Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention will perform |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Will undergo a cesarean section for the first time,
- Are over the age of 18,
- Have no diagnosed mental illness,
- Have no diagnosed physical illness in themselves or their baby,
- Volunteer to participate in the study
Key exclusion criteria (4 listed)
- Have previously undergone a cesarean section,
- Are under the age of 18,
- Have a diagnosed mental illness,
- Have a diagnosed physical illness in themselves or their baby, Do not volunteer to participate in the study. -
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 |
|---|---|---|
| Virtual reality glassesAlso: control groupcontrol group | Other | Virtual Reality Glasses |
Primary outcome
Spielberger State Anxiety Scale
Time frame: 30 minutes
The inventory was developed by Spielberger, Gorsuch, and Lushene in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety. The Cronbach's a for the STAI ranges from 0.83 to 0.87. It will be applied half an hour before the surgery.
Surgical Fear Scale (SFS):
Time frame: 30 minutes
The scale was developed by Theunissen et al. (2014) and its validity and reliability for use in Turkey were established by Bağdigen and Karaman Özlü (2018). The scale consists of 8 items in an 11-point Likert format, scored between 0 and 10. It is divided into two subscales, each containing 4 items, measuring short-term and long-term fears related to surgery. Items 1-4 assess fear regarding short-term outcomes of surgery, while items 5-8 evaluate fear concerning long-term outcomes. Each item is rated from "0: not afraid at all" to "10: extremely afraid." A higher total score, with a maximum of 26 points, indicates a greater level of fear. In the validity and reliability study, the Cronbach's alpha coefficient for the total score was found to be 0.93.It will be applied half an hour before the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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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.
Emine KOÇ, Asst.Prof study chair
Ondokuz Mayıs University
Nazlı Baltacı, Asst.Prof study chair
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality glasses in people with Anxiety, run by Ondokuz Mayıs 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sümeyye BAL, Ph.D (05434276696, sumeyyebal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberger State Anxiety Scale (time frame: 30 minutes). 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 22 Jan 2025.