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

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT05760040
Collaborator
(none)
80
1
2
6.5
12.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: vırtual reality
  • Other: Control Group
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Virtual Reality Application on Pain, Anxiety and Satisfaction of Patients During Intrauterine Device (Iud) Insertion
Actual Study Start Date :
Jul 15, 2022
Actual Primary Completion Date :
Oct 7, 2022
Actual Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality (VR)

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
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.

Experimental: Control group

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

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

Outcome Measures

Primary Outcome Measures

  1. Visual Analoque Scale =VAS [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]

    pain

Secondary Outcome Measures

  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.]

    Anxiety

Other Outcome Measures

  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.]

    satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University Istanbul Turkey

Sponsors and Collaborators

  • Marmara University

Investigators

  • Principal Investigator: tuğba öz, Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nurdan Demirci, PhD RN, Professor, Marmara University
ClinicalTrials.gov Identifier:
NCT05760040
Other Study ID Numbers:
  • MarmaraU-OZ-2023
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nurdan Demirci, PhD RN, Professor, Marmara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023