Clinical trial NCT06179095: The Effect of Virtual Reality on Anxiety During Intrauterine Device Insertion
Official title: The Effect of Virtual Reality on Anxiety During Intrauterine Device Insertion: Randomised Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Device
Keywords: Virtual Reality
Anxiety
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to determine whether the use of virtual reality glasses during intrauterine device insertion has an effect on the anxiety level of women.

Detailed description: Intrauterine device (IUD), which is one of the effective contraceptive methods in our country, is one of the known and frequently used methods. According to TDHS 2018 data, it was reported that 35% of women used IUD at some point in time, while the rate of women who were currently protected from pregnancy with IUD was 14% (TDHS, 2018). The fact that the rate of IUD use at any time is higher than the rate of current IUD users shows that the method is abandoned for various reasons (Kutlu \& Kılıçaslan, 2014). However, although it is the most well-known method and used by one in three women in a period, the low rate of IUD use may be due to reasons such as the need to go to a health institution for application and controls, the feeling of embarrassment, discomfort and fear due to lack of information about the procedure, as well as known side effects (Kartal et al., 2013; Tan et al., 2022). However, in today's practice, no attempt is made to remove or reduce the discomfort of women, especially from vaginal examinations.

It is known that virtual reality glasses are used in many areas. The most frequently used of these is the health sector. It can be used for educational purposes as well as for treatment and rehabilitation purposes. It has been stated that with virtual reality applications in treatment and rehabilitation processes, patient motivation will increase and patient fear and anxiety will decrease (Holden, 2005; Riener \& Harders, 2012;Öztürk \& Sondaş, 2020).

In the light of the literature, it was determined that virtual reality goggles were not applied to reduce women's fear, anxiety and anxiety during IUD application. In this context, this study was planned to determine whether virtual reality goggles affect the anxiety level of women during IUD application.

Eligibility criteria: Inclusion Criteria:

* -Volunteering to participate in the research
* Answering questionnaire and scale forms completely
* Read and understand Turkish
* 18 years of age or older
* STAI score of 35 and above
* Not being pregnant,
* No complaints of acute pelvic pain,
* No damage or leysone in the perineum that may cause pain during examination,
* Not using a pharmacological agent or method with analgesic or anxiolytic effect 24 hours before the application,
* No vaginismus problem,
* Absence of a history of sexual abuse,
* Not having any physical or mental problems that may prevent communication.

Exclusion Criteria:

* -Not volunteering to participate in the research,
* Incomplete responses to questionnaires and scale forms
* Not understanding Turkish,
* Under 18 years of age
* Do not score less than 35 points on the STAI,
* Don't be pregnant,
* Complaint of acute pelvic pain,
* Any damage or leysone in the perineum that may cause pain during examination,
* Having used a pharmacological agent or method with analgesic or anxiolytic effect 24 hours before the application,
* Having a vaginismus problem,
* Previous history of sexual abuse,
* Having any physical or mental problem that prevents communication.

Primary outcomes:
measure: Introductory Information Form
timeFrame: between one to six months
measure: The State/Trait Anxiety Inventory (STAI)
timeFrame: between one to six months
measure: Visual Anolag Scale (VAS)
timeFrame: between one to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: 1.Murat State Hospital
Study officials:
affiliation: Kırklareli University
name: remzire karadogan, Midwife
role: PRINCIPAL_INVESTIGATOR
References: