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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06346730
Other study ID # 142-18
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2024
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source Suleyman Demirel University
Contact Seda ÇU KARAÇAY YIKAR, assist
Phone 05416265614
Email sedakrcyyikar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date September 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Device:
Virtual reality glasses to intervention group
experimental and control ,a randomized pretest-posttest study to examine

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Suleyman Demirel University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. The research period for a participant takes approximately 30 minute
Primary 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. The research period for a participant takes approximately 30 minute
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