StressNCT06940583
Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy
A study testing VR and Podcast in people with Stress and Anxiety, run by Sinem Ceylan at 1 site in Turkey (Türkiye).
Trial summary
This study wants to see if two things-virtual reality (VR) and podcasts-can help women feel better during a medical test called colposcopy. The study looks at stress, anxiety, pain, and heartbeat. It also checks if women are happy with the test and how long the test takes. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- What is being tested?
- VR and Podcast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 30 Dec 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for colposcopy procedure due to suspicion of cervical squamous intraepithelial lesions.
- Individuals who agree to sign the informed consent form and are willing to participate after being informed about the procedure.
- Individuals who are deemed suitable for the colposcopy procedure and whose health status does not constitute an obstacle to perform this procedure (no visual or hearing impairment).
- Volunteers who speak Turkish at a level to understand the methods and questionnaires used in the study.
Who cannot join
- Those with claustrophobia, epilepsy, or any other neurological or psychological disorder that may cause discomfort when using the VR headset.
- Individuals with hearing loss that affects their ability to hear podcast content.
- Individuals with vision loss that affects their ability to see VR content.
- Individuals who have previously experienced discomfort while using VR or are unable to adapt to VR
- Individuals who are not suitable for the colposcopy procedure or have a serious health condition that may affect the procedure
- Individuals who are pregnant.
- Individuals with language barriers who may have difficulty understanding the study procedures or distractions.
- Individuals with regular use of sedative or pain medication that may affect stress or pain management during 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.
Özgün Ceylan contact
Turkey (Türkiye)1 site
Etlik City Hospital,Department of Gynecology Oncology
Ankara
Özgün Ceylan, +905372270678, ozguncyln@hotmail.com
About this study
Official title: Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy: A Randomized Controlled Trial
This study wants to see if two things-virtual reality (VR) and podcasts-can help women feel better during a medical test called colposcopy. The study looks at stress, anxiety, pain, and heartbeat. It also checks if women are happy with the test and how long the test takes.
There are three groups: one uses VR, one listens to a podcast, and one gets no extra help.
The study will include 75 women in Turkey. All women are 25 to 65 years old and need to have a colposcopy.
Some women cannot join the study-for example, if they are pregnant, cannot see or hear well, or take strong medicine for pain or stress.
- Conditions
- Stress, Anxiety, Pain, Colposcopy
- Being tested
- VR, Podcast
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VROther
Participants will view a relaxing virtual environment (e.g. nature landscapes, lightly animated themes) for 5 minutes prior to the colposcopy procedure and during the colposcopy wearing a VR headset.
PodcastOther
Participants will listen to a podcast of relaxing or informative content for 5 minutes before and 5 minutes during colposcopy. The content will be selected according to individual preferences (e.g. storytelling, humorous content or educational content).
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | Participants in this group will not receive any distraction during colposcopy. Only standard colposcopy information will be given. |
| Podcast | Experimental | Participants will listen to a podcast of relaxing or informative content for 5 minutes before and during colposcopy. Content is based on individual preferences Receives: Other: Podcast |
| VR | Experimental | Participants will view a relaxing virtual environment (e.g. nature landscapes, lightly animated themes) for 5 minutes prior to the colposcopy procedure and during the colposcopy wearing a VR headset. Receives: Other: VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
Developed by Cohen, Kamarck and Mermelstein (20) in 1983. PSS was first developed as a 14-item scale and has two other forms, 10 and 4 items. The scale was adapted to Turkish by Eskin et al. PSS was developed to measure the level of stress an individual perceives certain situations as. Participants evaluate the items on a 5-point Likert-type scale.
Measured: Before and after colposcopy at 5 min.
State Anxiety Inventory
This scale, developed by Spielberger and his colleagues, consists of two subscales, trait and state, each consisting of 20 questions. The state anxiety scale measures how an individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how an individual feels regardless of the situation and conditions they are in. The score obtained from the reversed statements is subtracted from the score obtained from the direct statements, and 50 is added to the resulting number for the state anxiety scale and 35 for the trait anxiety scale. The scores obtained from both scales vary between 20-80. As the score obtained from the scale increases, it is evaluated that the person's anxiety level is also high. The adaptation of the scale to Turkish, its validity and reliability study were conducted by Öner and Le Compt
Measured: Before and after colposcopy procedure 5 min.
Visual Analog Scale
The most commonly used and simplest scale. The scale includes numbers between 0-10, where "0" represents no pain and "10" represents the most severe pain. It is an easy-to-understand scale.
Measured: Before and after colposcopy procedure 5 min.
Secondary outcomes (3)
Patient Satisfaction Scale
"Would you rate your overall satisfaction during the colposcopy procedure on a scale of 0 to 10?" will be asked (0: Not satisfied at all - 10: Very satisfied)
Measured: 5 minutes after colposcopy procedure
Pulse measurement
Measured: 5 minutes before and after the colposcopy procedure.
Prosedur duration
Measured: During the colposcopy procedure (in minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinem Ceylan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sinem Ceylan, Gulhane School of Medicine
- Investigators
- Sinem Ceylan, Study chair, Ankara Medipol University,TurkeyÖzgün Ceylan, Principal investigator, Etlik City Hospital,Ankara,TurkeyVakkas Korkmaz, Study director, Etlik City Hospital,Ankara,TurkeyGülten Güvenç, Study chair, Turkey Health Science University,Gulhane Nursing Faculty, Ankara,TurkeyŞahin Kaan Baydemir, Study chair, Etlik City Hospital,Ankara,Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940583
- Sponsor's protocol ID
- VR24
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06940583
- Acronym / sponsor ID
- VR24
- Conditions
- Stress, Anxiety, Pain, Colposcopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sinem CeylanUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 23 Apr 2025 (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 wants to see if two things-virtual reality (VR) and podcasts-can help women feel better during a medical test called colposcopy. The study looks at stress, anxiety, pain, and heartbeat. It also checks if women are happy with the test and how long the test takes.
There are three groups: one uses VR, one listens to a podcast, and one gets no extra help.
The study will include 75 women in Turkey. All women are 25 to 65 years old and need to have a colposcopy.
Some women cannot join the study-for example, if they are pregnant, cannot see or hear well, or take strong medicine for pain or stress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –Participants in this group will not receive any distraction during colposcopy. Only standard colposcopy information will be given. |
| Podcast | Experimental | Other: PodcastParticipants will listen to a podcast of relaxing or informative content for 5 minutes before and during colposcopy. Content is based on individual preferences |
| VR | Experimental | Other: VRParticipants will view a relaxing virtual environment (e.g. nature landscapes, lightly animated themes) for 5 minutes prior to the colposcopy procedure and during the colposcopy wearing a VR headset. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for colposcopy procedure due to suspicion of cervical squamous intraepithelial lesions.
- Individuals who agree to sign the informed consent form and are willing to participate after being informed about the procedure.
- Individuals who are deemed suitable for the colposcopy procedure and whose health status does not constitute an obstacle to perform this procedure (no visual or hearing impairment).
- Volunteers who speak Turkish at a level to understand the methods and questionnaires used in the study.
Key exclusion criteria (8 listed)
- Those with claustrophobia, epilepsy, or any other neurological or psychological disorder that may cause discomfort when using the VR headset.
- Individuals with hearing loss that affects their ability to hear podcast content.
- Individuals with vision loss that affects their ability to see VR content.
- Individuals who have previously experienced discomfort while using VR or are unable to adapt to VR
- Individuals who are not suitable for the colposcopy procedure or have a serious health condition that may affect the procedure
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 |
|---|---|---|
| VRParticipants will view a relaxing virtual environment (e.g. nature landscapes, lightly animated themes) for 5 minutes prior to the colposcopy procedure and during the colposcopy wearing a VR headset. | Other | VR |
| PodcastParticipants will listen to a podcast of relaxing or informative content for 5 minutes before and 5 minutes during colposcopy. The content will be selected according to individual preferences (e.g. storytelling, humorous content or educational content). | Other | Podcast |
Primary outcome
Perceived Stress Scale
Time frame: Before and after colposcopy at 5 min.
Developed by Cohen, Kamarck and Mermelstein (20) in 1983. PSS was first developed as a 14-item scale and has two other forms, 10 and 4 items. The scale was adapted to Turkish by Eskin et al. PSS was developed to measure the level of stress an individual perceives certain situations as. Participants evaluate the items on a 5-point Likert-type scale.
State Anxiety Inventory
Time frame: Before and after colposcopy procedure 5 min.
This scale, developed by Spielberger and his colleagues, consists of two subscales, trait and state, each consisting of 20 questions. The state anxiety scale measures how an individual feels at a certain moment and under certain conditions, while the trait anxiety scale determines how an individual feels regardless of the situation and conditions they are in. The score obtained from the reversed statements is subtracted from the score obtained from the direct statements, and 50 is added to the resulting number for the state anxiety scale and 35 for the trait anxiety scale. The scores obtained from both scales vary between 20-80. As the score obtained from the scale increases, it is evaluated that the person's anxiety level is also high. The adaptation of the scale to Turkish, its validity and reliability study were conducted by Öner and Le Compt
Visual Analog Scale
Time frame: Before and after colposcopy procedure 5 min.
The most commonly used and simplest scale. The scale includes numbers between 0-10, where "0" represents no pain and "10" represents the most severe pain. It is an easy-to-understand scale.
3 secondary outcomes
Patient Satisfaction Scale
Time frame: 5 minutes after colposcopy procedure
Pulse measurement
Time frame: 5 minutes before and after the colposcopy procedure.
Prosedur duration
Time frame: During the colposcopy procedure (in minutes)
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 23 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Özgün Ceylan contact
Sinem Ceylan study chair
Ankara Medipol University,Turkey
Özgün Ceylan principal investigator
Etlik City Hospital,Ankara,Turkey
Vakkas Korkmaz study director
Etlik City Hospital,Ankara,Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR and Podcast in people with Stress and Anxiety, run by Sinem Ceylan 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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Apr 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 Sinem Ceylan, Dr. (05338186689, ceylansinem1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: Before and after colposcopy at 5 min.). The study lists 3 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 23 Apr 2025.