Virtual Reality(IUI)NCT06346730
The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI)
A study testing Virtual reality glasses to intervention group in people with Virtual Reality and Anxiety, run by Suleyman Demirel University.
Trial summary
This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Anxiety, Patient Satisfaction
- What is being tested?
- Virtual reality glasses to intervention group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 30 Sep 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 age group
- Primary infertile,
- Able to speak and understand Turkish,
- Are cognitive, effective and have no problems preventing communication,
- Having no psychiatric problems,
- Not diagnosed with epilepsy (due to the possibility of virtual reality (VR) glasses triggering epileptic seizures),
- Women who volunteer to participate in the study will be recruited.
Who cannot join
- Having a psychiatric problem,
- Diagnosed with epilepsy
- Those who want to leave the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI): Randomized Controlled Study
This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. Virtual reality glasses will be applied to the intervention group.
Read the detailed description
This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. These scales will be applied to both groups before and after Intrauterine Insemination (IUI).
Virtual reality glasses will be applied to the intervention group during intrauterine insemination (IUI).
Keywords: Virtual reality, anxiety, patient satisfaction, Intrauterine Insemination (IUI)
- Being tested
- Virtual reality glasses to intervention group
- Medical subject headings
- Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glasses to intervention groupDevice
experimental and control ,a randomized pretest-posttest study to examine
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses to intervention group | Experimental | Virtual reality glasses to intervention group, randomized pretest-posttest Receives: Device: Virtual reality glasses to intervention group |
| control | No intervention | Non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Trait Anxiety Inventory (STAI)
State Trait Anxiety Inventory (STAI) was designed to identify individuals' persistent anxiety and the level of anxiety felt towards the situation they are in. A total score between 20 and 80 can be obtained from both scales. Measuring ranges; 20-39 points are considered mild, 40-59 points are considered moderate, 60-79 points are considered severe anxiety, and 80 points are considered panic.
Measured: The research period for a participant takes approximately 30 minute
Patient's Perception of Nursing Care Scale
The Anxiety Inventory was designed to identify individuals' constant anxiety and the level of anxiety they feel about their current situation. A minimum of 15 and a maximum of 75 points can be obtained from the scale. An increase in the total score obtained from the scale indicates that the patient is satisfied with the nursing care.
Measured: The research period for a participant takes approximately 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Model description
- The sample will divide into intervention and control groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sevim AKBAY KISA, Suleyman Demirel University
- Investigators
- Evşen ÇU NAZİK, professor, Study chair, Cukurova UniversityAyşe Sevim SU Akbay Kısa, Ph.D, Study chair, Suleyman Demirel UniversityEbru Var, Study chair, Adana City Training and Research HospitalSefa ARLIER, professor, Study chair, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346730
- Sponsor's protocol ID
- 142-18
- Acronym
- (IUI)
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI): Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06346730
- Acronym / sponsor ID
- (IUI) / 142-18
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 4 Apr 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.
This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. Virtual reality glasses will be applied to the intervention group.
Detailed description
This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. These scales will be applied to both groups before and after Intrauterine Insemination (IUI).
Virtual reality glasses will be applied to the intervention group during intrauterine insemination (IUI).
Keywords: Virtual reality, anxiety, patient satisfaction, Intrauterine Insemination (IUI)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sample will divide into intervention and control groups
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses to intervention group | Experimental | Device: Virtual reality glasses to intervention groupVirtual reality glasses to intervention group, randomized pretest-posttest |
| control | No intervention | –Non-intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-45 age group
- Primary infertile,
- Able to speak and understand Turkish,
- Are cognitive, effective and have no problems preventing communication,
- Having no psychiatric problems,
Key exclusion criteria (3 listed)
- Having a psychiatric problem,
- Diagnosed with epilepsy
- Those who want to leave 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 glasses to intervention groupexperimental and control ,a randomized pretest-posttest study to examine | Device | Virtual reality glasses to intervention group |
Primary outcome
State Trait Anxiety Inventory (STAI)
Time frame: The research period for a participant takes approximately 30 minute
State Trait Anxiety Inventory (STAI) was designed to identify individuals' persistent anxiety and the level of anxiety felt towards the situation they are in. A total score between 20 and 80 can be obtained from both scales. Measuring ranges; 20-39 points are considered mild, 40-59 points are considered moderate, 60-79 points are considered severe anxiety, and 80 points are considered panic.
Patient's Perception of Nursing Care Scale
Time frame: The research period for a participant takes approximately 30 minute
The Anxiety Inventory was designed to identify individuals' constant anxiety and the level of anxiety they feel about their current situation. A minimum of 15 and a maximum of 75 points can be obtained from the scale. An increase in the total score obtained from the scale indicates that the patient is satisfied with the nursing care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- 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. This study is not recruiting at the moment.
Evşen ÇU NAZİK, professor study chair
Cukurova University
Ayşe Sevim SU Akbay Kısa, Ph.D study chair
Suleyman Demirel University
Ebru Var study chair
Adana City Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality glasses to intervention group in people with Virtual Reality and Anxiety, run by Suleyman Demirel University.
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 7 inclusion and 3 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seda ÇU KARAÇAY YIKAR, assist (05416265614 ext. nursing, sedakrcyyikar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Trait Anxiety Inventory (STAI) (time frame: The research period for a participant takes approximately 30 minute). 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 9 Apr 2024.