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

NCT05760040 | Completed DMC

• 1 other identifier: MarmaraU-OZ-2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety; Satisfaction

Keywords

Intrauterine device; Virtual Reality; pain; anxiety; satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State-Trait-Anxiety-Inventory

  The inventory is designed using a 4-point Likert scale. There are ten items in the State-Trait Anxiety Scale.

Other Outcomes (1)

• Patient Satisfaction Scale

  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.

Study Arms (2)

Virtual Reality (VR)

EXPERIMENTAL

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.

Other: vırtual reality

Control group

EXPERIMENTAL

Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.

Other: Control Group

Interventions

vırtual reality OTHER

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.

Virtual Reality (VR)

Control Group OTHER

Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women who underwent intrauterine device application
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Related 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.

  PMID: 29305105 BACKGROUND

• 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.

  PMID: 31094789 BACKGROUND

• 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.

  PMID: 24899241 BACKGROUND

• 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.

  PMID: 27046570 BACKGROUND

• 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.

  PMID: 29904806 BACKGROUND

• 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.

  PMID: 32321516 BACKGROUND

• 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.

  PMID: 25930099 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders; Personal Satisfaction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• tuğba öz

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD RN, Professor

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 8, 2023
• Study Start: July 15, 2022
• Primary Completion: October 7, 2022
• Study Completion: January 30, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)