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

Primary Purpose

Pain, Anxiety, Satisfaction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
vırtual reality
Control Group
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Intrauterine device, Virtual Reality, pain, anxiety, satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Virtual Reality (VR)

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Visual Analoque Scale =VAS
pain

Secondary Outcome Measures

State-Trait-Anxiety-Inventory
Anxiety

Full Information

First Posted
February 25, 2023
Last Updated
March 8, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05760040
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Satisfaction
Keywords
Intrauterine device, Virtual Reality, pain, anxiety, satisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality (VR)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.
Intervention Type
Other
Intervention Name(s)
vırtual reality
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Routine hospital protocol will be applied to 40 women included in the control group while intrauterine device application is being made.
Primary Outcome Measure Information:
Title
Visual Analoque Scale =VAS
Description
pain
Time Frame
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 Outcome Measure Information:
Title
State-Trait-Anxiety-Inventory
Description
Anxiety
Time Frame
The inventory is designed using a 4-point Likert scale. There are ten items in the State-Trait Anxiety Scale.
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction Scale
Description
satisfaction
Time Frame
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women who underwent intrauterine device application
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tuğba öz
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
can be shared after the publication of the article.
Citations:
PubMed Identifier
29305105
Citation
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.
Results Reference
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PubMed Identifier
31094789
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.
Results Reference
background
PubMed Identifier
24899241
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.
Results Reference
background
PubMed Identifier
27046570
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.
Results Reference
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PubMed Identifier
29904806
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.
Results Reference
background
PubMed Identifier
32321516
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.
Results Reference
background
PubMed Identifier
25930099
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.
Results Reference
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The Effect of Virtual Reality Application on Pain, Anxiety and Satisfaction of Patients

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