The Effect of Virtual Reality Glasses Pain, Anxiety and Satisfaction Level in Intrauterine Device Application' (Virtual)

April 10, 2023 updated by: Mine Gokduman Keles

The Effect of Virtual Reality Glasses and Distraction Cards on Women's Pain, Anxiety and Satisfaction Level in Intrauterine Device Application'

The aim of this study is to examine the effects of virtual reality glasses and distraction cards, which are cognitive behavioral techniques, on women's pain, anxiety and satisfaction levels. It is aimed to reduce your anxiety level, reduce pain level and increase feelings of satisfaction by showing you a nature video with Virtual Reality Glasses or showing distraction cards so that you can spend this process more comfortably while IUD is being applied. The following questions are expected to be answered in this research: When virtual reality glasses and distraction cards are applied during the IUD procedure; (1) Does it affect the woman's pain level? (2) Does it affect the woman's anxiety level? (3) does it have an effect on women's satisfaction? In addition, it is aimed to reveal the effectiveness of virtual reality glasses and distraction cards in the IUD application process, which is one of the modern family planning methods in midwifery applications, and to bring a non-invasive and cost-effective option into practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The proportion of women who want to use Family Planning in the world in the last two decades has reached approximately 1.1 billion and has shown a significant increase . Despite this increasing demand, it is seen that there has been a slow increase of 3.2 in the ratio of family planning (FP) needs met by modern contraceptive methods for women of reproductive age in the last ten years. The reasons for this slow increase include limited access to modern contraceptive methods, women's prejudice about some methods, and low quality of available services . In addition, WHO reported that almost half of pregnancies in developing countries between 2015 and 2019 were unwanted pregnancies , and recommended effective FP counseling and the use of more modern contraceptive methods to prevent this . In Turkey, the Ministry of Health provides individuals with free access to modern FP methods. Despite this, according to 2018 data of the Turkey Demographic and Health Survey (TNSA), it has been reported that 49% use modern methods in the use of FP method, and the Intrauterine Device (IUD) is among the most effective modern methods with a rate of 14% . Among the factors affecting the use of the IUD; women's perception of pain during the application and the fact that it can be applied in certain centers .

In addition, it has been reported in the literature that women perceive pain during IUD application. In these studies, pain; especially used in the stages of IUD application; It is reported that it is detected during tenaculum insertion, measurement with a hysterometer, and finally during IUD insertion. For this reason, there is a need for applications to reduce the pain associated with the IUD application, which is the modern FP method of women. Again, it is assumed that women will experience anxiety before the IUD application as in other medical procedures . It is seen in the literature that there are studies to alleviate the perceived pain in IUD application . In addition, it is expected that the applications made to women for the symptoms such as pain and anxiety related to the applications in the field of health will increase their satisfaction . In this context, there are studies in the literature showing that virtual reality glasses and distraction cards, which are cognitive behavioral techniques, are used during medical procedures, reducing the perception of pain and reducing the level of anxiety. . Although virtual reality glasses are a technological device, they have been widely used in the medical field in hospitals. Virtual reality glasses to be used in the research are not a medical device. This device is a technological glasses that works with compatible smartphones. The applications to be made with this device are within the framework of midwifery care applications and are not a treatment method, mediator or treatment option for any disease and do not have any harmful effects. Again, the cards with optical illusion figures on the distraction cards enable women to focus and reduce pain and anxiety.

No study has been found in the literature examining the effects of virtual reality glasses and distraction techniques on pain, anxiety and satisfaction levels in IUD application. However, in line with the results of the study, it is thought that the IUD procedure will have a positive effect on reducing the perceived pain and anxiety of women and increase satisfaction.

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Kahramanmaraş, Turkey, 46050
        • Recruiting
        • TurkishMoHKahramanmarasPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • between the ages of 18-45,
  • IUD applied,

Exclusion Criteria:

  • Having visual and auditory disabilities,
  • Use of misoprostol during the procedure,
  • Pre-procedure pain medication use,
  • Pre-procedure anxiety medication use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: working grup 1: Virtual Reality (VR) Group

From the preparation stage of the IUD until the IUD application process is completed, after the internet connection is provided with a smart phone for the image, by clicking on the youtube.com link, Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video will be provided and virtual reality glasses will be provided.

Virtual reality glasses to be used in the research are not a medical device. This device is a technological glasses that works with compatible smartphones. The practice of watching nature videos with VR during the IUD application with this device is within the framework of midwifery care practices and is not a treatment option for any treatment method, tool or disease. Although the video watched with VR has no effect on medical treatment and care within the framework of midwifery care, it does not have any harmful effects on women. The participant can withdraw from this study at any time without giving any reason.
Device: Virtual Reality (VR) Group

At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.

  • An introductory information form will be filled in for women in all three groups.
  • While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
  • Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
  • The Control Group will be given routine IUD application and care.
Experimental: Working Group 2: Distraction Cards Implementation Group
From the preparation stage of the IUD procedure to the completion of the IUD application process, distraction cards containing five optical illusion figures, one of the distraction techniques, will be shown to the women by the researcher . Distraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns are such that individuals can only see when they look carefully. During the process, the women will focus on the cards and be distracted by asking what they see on the cards by communicating face-to-face with the researcher women about the pictures and shapes they see on the cards. Thus, it is thought that the cards with optical figures on the distraction cards will enable women to focus and reduce pain and anxiety. Display of cards will take approximately 3-5 minutes
Device: Group using distraction cards

At the beginning of the study, the women who applied for the IUD procedure will be interviewed, and then the following procedures will be applied; Informed consent of all women will be obtained about the study.

  • An introductory information form will be filled in for women in all three groups.
  • While the Intervention Group 1 IUD is being applied, a nature video will be watched with Virtual Glasses.
  • Distraction Cards will be shown while the Intervention Group 2 IUD is being administered.
  • The Control Group will be given routine IUD application and care.
No Intervention: Control Group
Unlike the study group, women included in the control group will not only be shown video watching applications with virtual glasses and distraction cards. The maintenance and applications in the routine IUD application will be done exactly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse Rate and Oxygen Saturation
Time Frame: ria application restriction averages 20 minutes
The pulse rate and saturation values of women will be evaluated physiologically using the sensor compatible planet 50n LT model pulse oximeter (Nellcor COVIDIEN SPO 2) device.
ria application restriction averages 20 minutes
Verbal Category (SKO)
Time Frame: Before the examination; (2) Speculum insertion; (3) Application of the tenaculum to the cervix; (4) During IUD insertion; (5) It will be evaluated five times in total, 15 minutes after the IUD administration (5).
Verbal Category Scale (SCA) (Appendix 4): The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient's choice of the most appropriate word to describe the pain condition. Pain severity ranges from mild to unbearable. In this scale, he used the words "mild", "disturbing", "severe", "very severe", "unbearable" to describe the severity of pain (Appendix-5). The individual is asked to choose the appropriate category for his situation.
Before the examination; (2) Speculum insertion; (3) Application of the tenaculum to the cervix; (4) During IUD insertion; (5) It will be evaluated five times in total, 15 minutes after the IUD administration (5).
Numerical Pain Rating Scale (SAAS)
Time Frame: Before the examination; (2) Speculum insertion; (3) Application of the tenaculum to the cervix; (4) During IUD insertion; (5) It will be evaluated five times in total, 15 minutes after the IUD administration (5).
Numerical pain rating scale (SARS) is used to evaluate pain severity. In the numerical evaluation scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
Before the examination; (2) Speculum insertion; (3) Application of the tenaculum to the cervix; (4) During IUD insertion; (5) It will be evaluated five times in total, 15 minutes after the IUD administration (5).
State Anxiety Scale (STAI TX-I)
Time Frame: Before and after IUD procedure
items are answered by marking one of the options such as (1) none, (2) a little, (3) a lot, (4) a lot, depending on the severity of the emotion or behavior. There are two types of expressions in the scale. These are reversed or straight forward expressions. reversed expressions; positive emotions express, while direct expressions express negative emotions. When scoring reverse expressions, those with a weight of 1 are converted to 4, and those with a weight of 4 are converted to 1. In the State Anxiety Scale; There are ten reversed statements, items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. When scoring, the reversed and direct statements are summed. ints.
Before and after IUD procedure
Newcastle Nursing Care Satisfaction Scale (NHMS)
Time Frame: ria application restriction averages 20 minutes
The scale is a 5-point Likert-type scale consisting of 19 items covering nursing care. All items of the Newcastle Nursing Care Satisfaction Scale are positive. In the scoring used to determine the degree of satisfaction, there are statements such as "Not at all Satisfied=1 point, Slightly Satisfied=2 points, Fairly Satisfied=3 points, Very Satisfied=4 points, Extremely Satisfied=5 points". The scores given to the questions of all items marked on the score evaluation scale are added together. The maximum score obtained from the scale is 95, and the minimum score is 19. Evaluation is made by converting the total score obtained from the scale to 100.
ria application restriction averages 20 minutes
Virtual Reality Glasses Application Question
Time Frame: ria application restriction averages 20 minutes
Virtual Reality Glasses Application Question,It was created by scanning the literature by the researcher.
ria application restriction averages 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mine Gokduman Keles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TurkishMoHKahramanmaras

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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