The Effect of Virtual Reality on Anxiety During Intrauterine Device Insertion

NCT06179095 | Completed

• 1 other identifier: KırklareliED-4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to determine whether the use of virtual reality glasses during intrauterine device insertion has an effect on the anxiety level of women.

Conditions

Intrauterine Device

Keywords

Virtual Reality; Anxiety

Outcome Measures

Primary Outcomes (3)

• Introductory Information Form

  The form consists of questions about socio-demographic and intrauterine device insertion

  between one to six months

• The State/Trait Anxiety Inventory (STAI)

  This inventory was developed by Spielberg in 1973 and each of the subscales ranges from 1 (not at all) to 4 (very much). The lowest and highest scores that can be obtained from each subscale are 20 and 80, respectively. Higher scores are associated with more anxiety. The alpha value of the scale varies between 0.86 and 0.92 . Öner et al. 1983, it was shown that the alpha value of the Turkish version of the STAI ranged between 0.83 and 0.87.27.

  between one to six months

• Visual Anolag Scale (VAS)

  It was developed by Price et al. (1983) to assess the severity of pain (Price et al. 1983). It is a line, usually 10 cm long, horizontal or vertical, starting with "No Pain" and ending with "Intolerable Pain". This line may be just a straight line, or it may be divided into equal intervals, or it may have description words placed on the line to describe pain. It is generally accepted that the vertical line is easier to understand. The patient indicates the intensity of his/her pain with a mark on this line where he/she deems appropriate. The distance between the beginning of no pain and this point is measured in "cm" and recorded. Values vary between 0 and 10 and higher values indicate increased pain. Turkish validity and reliability was performed by Eti Aslan (Eti Aslan, 2004).

  between one to six months

Study Arms (2)

Virtual reality group

EXPERIMENTAL

Virtual reality to be applied to women undergoing intrauterine device insertion.

Other: Virtual reality

Control group

NO INTERVENTION

Participants in this group will consist of people who do not routinely do any practive on their own to reduce anxiety during intrauterine device insertion.

Interventions

Virtual reality OTHER

Participants will view a specific relaxing and distracting scenario using virtual reality (VR) for approximately 7-8 minutes from one minute before the procedure until the end of the procedure. Assessment will be performed with STAI just before the intrauterine device insertion procedure, and again with STAI after the procedure.

Virtual reality group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the research
• Answering questionnaire and scale forms completely
• Read and understand Turkish
• years of age or older
• STAI score of 35 and above
• Not being pregnant,
• No complaints of acute pelvic pain,
• No damage or leysone in the perineum that may cause pain during examination,
• Not using a pharmacological agent or method with analgesic or anxiolytic effect 24 hours before the application,
• No vaginismus problem,
• Absence of a history of sexual abuse,
• Not having any physical or mental problems that may prevent communication.

You may not qualify if:

• Not volunteering to participate in the research,
• Incomplete responses to questionnaires and scale forms
• Not understanding Turkish,
• Under 18 years of age
• Do not score less than 35 points on the STAI,
• Don't be pregnant,
• Complaint of acute pelvic pain,
• Any damage or leysone in the perineum that may cause pain during examination,
• Having used a pharmacological agent or method with analgesic or anxiolytic effect 24 hours before the application,
• Having a vaginismus problem,
• Previous history of sexual abuse,
• Having any physical or mental problem that prevents communication.

Sponsors & Collaborators

• Kırklareli University: lead

Study Sites (1)

1.Murat State Hospital

Edirne, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• remzire karadogan, Midwife

  Kırklareli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: May 1, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 26, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

TU (1)