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

NCT05655052 | Unknown

• 1 other identifier: TurkishMoHKahramanmaras
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Virtual Reality; Pain; Anxiety; Distraction Cards

Outcome Measures

Primary Outcomes (6)

• Pulse Rate and Oxygen Saturation

  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)

  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)

  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)

  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)

  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

  Virtual Reality Glasses Application Question,It was created by scanning the literature by the researcher.

  ria application restriction averages 20 minutes

Study Arms (3)

working grup 1: Virtual Reality (VR) Group

EXPERIMENTAL

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

Working Group 2: Distraction Cards Implementation Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Virtual Reality (VR) Group DEVICE

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.

working grup 1: Virtual Reality (VR) Group

Group using distraction cards DEVICE

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.

Working Group 2: Distraction Cards Implementation Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: IUD applied,
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mine Gokduman Keles: lead

Study Sites (1)

TurkishMoHKahramanmarasPH

Kahramanmaraş, 46050, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Grimes DA, Lopez LM, Manion C, Schulz KF. Cochrane systematic reviews of IUD trials: lessons learned. Contraception. 2007 Jun;75(6 Suppl):S55-9. doi: 10.1016/j.contraception.2006.12.004. Epub 2007 Feb 16.

  PMID: 17531618 BACKGROUND

• Dina B, Peipert LJ, Zhao Q, Peipert JF. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018 Feb;218(2):236.e1-236.e9. doi: 10.1016/j.ajog.2017.10.017. Epub 2017 Nov 8.

  PMID: 29079143 BACKGROUND

• Gemzell-Danielsson K, Jensen JT, Monteiro I, Peers T, Rodriguez M, Di Spiezio Sardo A, Bahamondes L. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review. Acta Obstet Gynecol Scand. 2019 Dec;98(12):1500-1513. doi: 10.1111/aogs.13662. Epub 2019 Jun 27.

  PMID: 31112295 BACKGROUND

• Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019 Jun;24(3):240-245. doi: 10.1080/13625187.2019.1610872. Epub 2019 May 16.

  PMID: 31094575 RESULT

• Hylton J, Milton S, Sima AP, Karjane NW. Cold Compress for Intrauterine Device Insertional Pain: A Randomized Control Trial. Womens Health Rep (New Rochelle). 2020 Aug 4;1(1):227-231. doi: 10.1089/whr.2020.0056. eCollection 2020.

  PMID: 33786484 RESULT

• Toker E, Gokduman Keles M. The Impact of Virtual Reality with Relaxation Music and Distraction Cards on Pain, Anxiety, and Satisfaction Levels of Women with an Intrauterine Device: A Randomized Controlled Trial. J Midwifery Womens Health. 2025 Nov 14. doi: 10.1111/jmwh.70048. Online ahead of print.

  PMID: 41235692 DERIVED

Related Links

• Home/Newsroom/Fact sheets/Detail/Family planning/contraception method
• WHO. New estimates show worldwide fall in unintended pregnancies since 1990-1994. 2020.
• High rates of unintended pregnancies linked to gaps in family planning services: New WHO study
• TNSA. Türkiye Nüfus ve Sağlık Araştırması 2018 Ne Söylüyor? 2018

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

mine gökduman keleş

CONTACT

05055624560; minegkdmn@hotmail.com

Eylem Toker

CONTACT

eylem7@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: According to the AP Polyclinic admission sequence number and from the list determined by randomization (determined from the www.randomizer.org site), which group it is in will be determined. Study and control group assignments will be made. It will be applied by the health personnel working in the Family Planning Counseling Polyclinic.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Midwifery

Model Details: : A randomized controlled trial

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 16, 2022
• Study Start: November 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

TU (1)