- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06346730
The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI) ((IUI))
The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI): Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Seda ÇU KARAÇAY YIKAR, assist
- Phone Number: nursing 05416265614
- Email: sedakrcyyikar@gmail.com
Study Contact Backup
- Name: Ayşe Sevim SU Akbay Kısa, Ph.D
- Phone Number: nursing 05435872734
- Email: ayse.sevim.32@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Having a psychiatric problem,
- Diagnosed with epilepsy
- Those who want to leave the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual reality glasses to intervention group
Virtual reality glasses to intervention group, randomized pretest-posttest
|
experimental and control ,a randomized pretest-posttest study to examine
|
No Intervention: control
Non-intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The research period for a participant takes approximately 30 minute
|
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.
|
The research period for a participant takes approximately 30 minute
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Evşen ÇU NAZİK, professor, Çukurova university
- Study Chair: Ayşe Sevim SU Akbay Kısa, Ph.D, Suleyman Demirel University
- Study Chair: Ebru Var, Adana City Training and Research Hospital
- Study Chair: Sefa ARLIER, professor, Adana City Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 142-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on Virtual reality glasses to intervention group
-
Akdeniz UniversityEnrolling by invitation
-
Seher TanrıverdiNot yet recruitingArthroscopic Surgical Procedures
-
Suleyman Demirel UniversityNot yet recruitingMisadventure During Endoscopic ExaminationTurkey
-
Karabuk UniversityCompletedFractures, Bone | Pain, Acute | Anxiety AcuteTurkey
-
Cumhuriyet UniversityNot yet recruitingDIALYSIS SYMPTOMS AND ANXIETYTurkey
-
Necmettin Erbakan UniversityHealth Institutes of TurkeyCompleted
-
Özlem ÇiçekIzmir Bakircay UniversityCompletedEpisiotomy WoundTurkey
-
Istanbul Sabahattin Zaim UniversityCompleted
-
Esra DOĞAN YILMAZ, RN, MScCompletedThe Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing ColonoscopyAnxiety | Colonoscopy | Vital SignsTurkey
-
Saglik Bilimleri UniversitesiUnknown