Bleeding;Post D&CNCT06403579
THE EFFECT OF VIRTUAL REALITY APPLICATION ON PAIN, ANXIETY, AND COMFORT DURING CURETTAGE/DILATATION
A study testing virtula reality goggles in people with Bleeding;Post D&C and PAIN, ANXIETY, AND COMFORT, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The problems experienced by women at the stage of deciding to have a miscarriage, during and after miscarriage differ and their anxiety levels vary. It was determined that women experienced fear, thinking that they would sin, guilt, regret and indecision at the stage of deciding to abort. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bleeding;Post D&C, PAIN, ANXIETY, AND COMFORT
- What is being tested?
- virtula reality goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 May 2025
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 15-49 years old,
- Termination ordered,
- Can speak and understand Turkish,
Who cannot join
- - Cognitive, effective and without any problem preventing communication,
- No psychiatric problems,
- Diagnosed with epilepsy (due to the risk that SG glasses may trigger epileptic seizures),
- Women who volunteer to participate in the study will be recruited.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF VIRTUAL REALITY APPLICATION ON PAIN, ANXIETY, AND COMFORT DURING CURETTAGE/DILATATION: A RANDOMIZED CONTROLLED TRIAL
The problems experienced by women at the stage of deciding to have a miscarriage, during and after miscarriage differ and their anxiety levels vary. It was determined that women experienced fear, thinking that they would sin, guilt, regret and indecision at the stage of deciding to abort. methods are used to relieve the pain and anxiety caused by interventional procedures in patients in direct proportion to the development of technology. Virtual reality (VR), one of these methods, is an innovative, up-to-date and unique application, combining reality and imagination with fictional technology.There is no study in the literature on the application of SG during curettage/dilatation procedure. This study was conducted to determine the effect of SG application on pain anxiety and comfort during curettage/dilatation procedure.
- Conditions
- Bleeding;Post D&C, PAIN, ANXIETY, AND COMFORT
- Being tested
- virtula reality goggles
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtula reality gogglesDevice
Also called control
no intervention
| Study group | Role | What they receive |
|---|---|---|
| virtual reality application | Experimental | Experimental: virtual reality application virtual reality goggles will be implemented. Receives: Device: virtula reality goggles |
| control | Sham comparator | No Intervention: control group no intervention will be made Receives: Device: virtula reality goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
virtual reality application
virtual reality application reduces women's pain scores 0-5 points
Measured: at 1 hour after curettage
virtual reality application
virtual reality application reduces women's anxiety scores 20-39 points
Measured: at 1 hour after curettage
virtual reality application virtual reality application
virtual reality application reduces women's anxiety scores 24-144 points
Measured: at 1 hour after curettage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding;Post D&CStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seda karaçay yıkar, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403579
- Sponsor's protocol ID
- 142-16
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 8 May 2024
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF VIRTUAL REALITY APPLICATION ON PAIN, ANXIETY, AND COMFORT DURING CURETTAGE/DILATATION: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT06403579
- Acronym / sponsor ID
- 142-16
- Conditions
- Bleeding;Post D&C, PAIN, ANXIETY, AND COMFORT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 8 May 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 problems experienced by women at the stage of deciding to have a miscarriage, during and after miscarriage differ and their anxiety levels vary. It was determined that women experienced fear, thinking that they would sin, guilt, regret and indecision at the stage of deciding to abort. methods are used to relieve the pain and anxiety caused by interventional procedures in patients in direct proportion to the development of technology. Virtual reality (VR), one of these methods, is an innovative, up-to-date and unique application, combining reality and imagination with fictional technology.There is no study in the literature on the application of SG during curettage/dilatation procedure. This study was conducted to determine the effect of SG application on pain anxiety and comfort during curettage/dilatation procedure.
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 application | Experimental | Device: virtula reality gogglesExperimental: virtual reality application virtual reality goggles will be implemented. |
| control | Sham comparator | Device: virtula reality gogglesNo Intervention: control group no intervention will be made |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 15-49 years old,
- Termination ordered,
- Can speak and understand Turkish,
Key exclusion criteria (4 listed)
- - Cognitive, effective and without any problem preventing communication,
- No psychiatric problems,
- Diagnosed with epilepsy (due to the risk that SG glasses may trigger epileptic seizures),
- Women who volunteer to participate in the study will be recruited.
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 |
|---|---|---|
| virtula reality gogglesAlso: controlno intervention | Device | control, virtual reality application |
Primary outcome
virtual reality application
Time frame: at 1 hour after curettage
virtual reality application reduces women's pain scores 0-5 points
virtual reality application
Time frame: at 1 hour after curettage
virtual reality application reduces women's anxiety scores 20-39 points
virtual reality application virtual reality application
Time frame: at 1 hour after curettage
virtual reality application reduces women's anxiety scores 24-144 points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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 virtula reality goggles in people with Bleeding;Post D&C and PAIN, ANXIETY, AND COMFORT, run by Cukurova 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 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
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?
virtual reality application (time frame: at 1 hour after curettage). 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 8 May 2024.