Clinical trial NCT05760040: The Effect of Virtual Reality Application on Pain, Anxiety and Satisfaction of Patients
Official title: The Effect of Virtual Reality Application on Pain, Anxiety and Satisfaction of Patients During Intrauterine Device (Iud) Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Satisfaction
Keywords: Intrauterine device
Virtual Reality
pain
anxiety
satisfaction
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Today, common and easily accessible android-based smart devices capable of running virtual reality are used. The image is obtained using a combination of framed simple optical lenses that hold the phone at a fixed distance perpendicular to the user's gaze direction. The working system of three-dimensional resuscitation devices is based on stereographic vision properties. After the relevant applications are installed on the smartphone, the device divides the screen into two, and thanks to the acquisition of different images for the right and left eyes, the illusion of the spatial existence of three-dimensional animated objects is obtained.

The use of virtual reality application, which is used as a non-pharmacological method in different studies, has not been found in IUD (Intrauterine device) applications. This study was planned to examine the effect of virtual reality applications, which will distract their attention during the procedure, on the pain and anxiety levels experienced in women who underwent IUD in the septic area in Esenyurt Necmi Kadıoğlu State Hospital.

Detailed description: Virtual Reality, which is a type of computer system using human-machine interfaces, has been used in pain and anxiety management in different applications in many areas known as painful medical procedures in recent years. According to the researchers' hypotheses, Virtual Reality acts as a non-pharmacological method, using cognitive and attentional processes on the body's complex pain modulation system. Although the neurobiological mechanisms have not been fully explained in studies, it has been reported that virtual reality applications have positive results in pain management. When patients feel that they are in the image, their attention is effectively distracted from the pain. Thus, the existing perception of pain decreases.

In recent years, virtual reality as a distraction application has been used in clinical medical care to relieve pain. Virtual Reality applications; There are studies showing its effectiveness in pain and anxiety management in many areas such as burn debridement, injection applications, wound care, toothache, endoscopy procedure, phantom and chronic pain, and chemotherapy applications.

The use of virtual reality application, which is used as a non-pharmacological method in different studies, has not been found in IUD (Intrauterine device) applications. This study was planned to examine the effect of virtual reality applications, which will distract their attention during the procedure, on the pain and anxiety levels experienced in women who underwent IUD in the septic area in Esenyurt Necmi Kadıoğlu State Hospital.

Eligibility criteria: Inclusion Criteria:

* Not having any psychiatric disease,
* Having no vision, hearing and perception problems,
* At least primary school graduate,
* Can read and write Turkish,
* Hemodynamically stable,
* No previous experience of intrauterine device application women

Exclusion Criteria:

* Under 18 years old,
* Having any psychiatric disease,
* Having vision, hearing and perception problems,
* Illiterate,
* Hemodynamically unstable,
* Women who have had an intrauterine device before

Primary outcomes:
measure: Visual Analoque Scale =VAS
timeFrame: The VAS is a 100 mm (10 cm) ruler that can be used horizontally or vertically. The value "0" at the beginning level defines painlessness, and the value "10" at the end level defines the most severe pain
Secondary outcomes:
measure: State-Trait-Anxiety-Inventory
timeFrame: The inventory is designed using a 4-point Likert scale. There are ten items in the State-Trait Anxiety Scale.
Other outcomes:
measure: Patient Satisfaction Scale
timeFrame: It is a form consisting of Likert-type questions to determine the satisfaction levels of women prepared by the researchers in line with the literature.
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: tuğba öz
role: PRINCIPAL_INVESTIGATOR
References:
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