The Effect of Virtual Reality Application on Pain, Anxiety and Satisfaction of Patients

Pain Clinical Trial

Official title:

The Effect of Virtual Reality Application on Pain, Anxiety and Satisfaction of Patients During Intrauterine Device (Iud) Insertion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05760040
• Other study ID #: MarmaraU-OZ-2023
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 30, 2023
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Satisfaction

Intervention

Other:
• virtual reality
During the intrauterine device application, 40 women who were included in the virtual reality group will be put on virtual reality glasses and watched the video.
• Control Group
Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Ford CG, Manegold EM, Randall CL, Aballay AM, Duncan CL. Assessing the feasibility of implementing low-cost virtual reality therapy during routine burn care. Burns. 2018 Jun;44(4):886-895. doi: 10.1016/j.burns.2017.11.020. Epub 2018 Jan 2. — View Citation

Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649. — View Citation

Guo C, Deng H, Yang J. Effect of virtual reality distraction on pain among patients with hand injury undergoing dressing change. J Clin Nurs. 2015 Jan;24(1-2):115-20. doi: 10.1111/jocn.12626. Epub 2014 Jun 4. — View Citation

Jin W, Choo A, Gromala D, Shaw C, Squire P. A Virtual Reality Game for Chronic Pain Management: A Randomized, Controlled Clinical Study. Stud Health Technol Inform. 2016;220:154-60. — View Citation

Matheve T, Bogaerts K, Timmermans A. Virtual reality distraction induces hypoalgesia in patients with chronic low back pain: a randomized controlled trial. J Neuroeng Rehabil. 2020 Apr 22;17(1):55. doi: 10.1186/s12984-020-00688-0. — View Citation

Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual Reality as a Clinical Tool for Pain Management. Curr Pain Headache Rep. 2018 Jun 15;22(8):53. doi: 10.1007/s11916-018-0708-2. — View Citation

Won AS, Tataru CA, Cojocaru CM, Krane EJ, Bailenson JN, Niswonger S, Golianu B. Two Virtual Reality Pilot Studies for the Treatment of Pediatric CRPS. Pain Med. 2015 Aug;16(8):1644-7. doi: 10.1111/pme.12755. Epub 2015 Apr 30. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction Scale	satisfaction	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.
Primary	Visual Analoque Scale =VAS	pain	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	State-Trait-Anxiety-Inventory	Anxiety	The inventory is designed using a 4-point Likert scale. There are ten items in the State-Trait Anxiety Scale.