Virtual Reality-Assisted Nursing Intervention During Intrauterine Device Insertion

NCT07580885 | Completed DMC

• 2 other identifiers: SANKO UNIVERSITYYASEMİN ATEŞEYAN
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of Virtual Reality-Assisted Nursing Intervention on Pain and Anxiety During Intrauterine Device Insertion: A Randomized Controlled Trial April 30, 2026 The aim of this study was to evaluate the effect of a virtual reality-assisted nursing intervention on participants' pain, anxiety, physiological parameters and comfort levels during Intrauterine Device (IUD) insertion. In this context, the study which hypothesises that the virtual reality application will reduce pain and anxiety during the procedure, support physiological stability, and enhance participants' comfort levels was designed as a randomised controlled trial.

Conditions

Anxiety; Pain Management; Virtual Reality; Nursing Interventions

Keywords

Virtual Reality; Pain; Anxiety; Nursing Intervention

Outcome Measures

Primary Outcomes (1)

• Pain Level

  Pain intensity experienced during intrauterine device insertion, measured using a Visual Analog Scale.The score obtained from the scale ranges from 0 to 10. 0 means no pain, and 10 describes the most severe form of pain.

  Immediately post-procedure (speculum, tenaculum, immediately after insertion, and post-procedure)

Secondary Outcomes (2)

• Anxiety Level

  Immediately post-procedure (speculum, tenaculum, immediately after insertion, and post-procedure)

• Comfort Level

  5 minutes before starting the IUD insertion procedure and 5 minutes after completing the IUD insertion procedure.

Study Arms (2)

VR Group

OTHER

Intervention Name: Virtual Reality Intervention Intervention Type: Device (veya Behavioral) Assign to Arm: Experimental Group

Other: via virtual reality goggles

Control Group

OTHER

Intervention Name: Routine Care Assign to: Control Group

Other: via virtual reality goggles

Interventions

via virtual reality goggles OTHER

Intervention Name: Virtual Reality Intervention Description: Participants in the experimental group received a virtual reality-assisted nursing intervention during intrauterine device insertion. A virtual reality headset was used to present a 3D immersive video including relaxing natural scenes and calming background music. The intervention was applied continuously throughout the procedure to distract attention from the procedure and reduce pain and anxiety. Intervention Name: Routine Care Description: Participants in the control group received routine care during intrauterine device insertion without the use of virtual reality or any additional distraction method.

Control Group; VR Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years and older
• Being sexually active
• Having decided to have an IUD inserted
• Being gynecologically suitable for an IUD
• Having no communication impediment

You may not qualify if:

• Visual or hearing impairment
• Diagnosed psychiatric illness
• History of epilepsy
• Severe dizziness or condition that prevents VR use
• IUD contraindications detected during gynecological examination

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Women's and Children's Hospital

Gaziantep, 27270, Turkey (Türkiye)

Location

Related Publications (3)

• Aydın, A., Araz, A., Asan, A. 2011. Görsel Analog Ölçeği ve Duygu Kafesi: Kültürümüze Uyarlama Çalışması, Türk Psikoloji Yazıları,14 (27), 1-13.

  BACKGROUND

• Kolcaba, K. (2003). Comfort Theory and Practice A vision for holistik health care and research, Springer Publishing Company. New York

  BACKGROUND

• Kuğuoğlu, S., & Karabacak, Ü. (2008). Genel Konfor Ölçeğinin Türkçe 'ye uyarlanması. İstanbul Üniversitesi Florence Nightingale Hemşirelik Yüksekokulu Dergisi, 61(16), 16-23.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Agnosia; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasemin ATEŞEYAN, PhD

  MERSİN UNIVERSITY

  PRINCIPAL INVESTIGATOR

• Esra VERİM, PhD

  GAZİANTEP UNIVERSITY

  STUDY CHAIR

• Emine BAŞ, PhD

  Sanko University

  STUDY CHAIR

• Zeynep GÜNGÖRMÜŞ, Prof

  Gaziantep Islam Science and Technology University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In this study, given the nature of the intervention, it was anticipated that conducting the experimental and control groups on the same day could lead to information transfer between participants via communication (contamination) and behaviour changes related to the intervention (Hawthorne effect). Furthermore, administering the virtual reality application to some participants whilst not administering it to others within the same clinical setting could create a perception of unequal treatment among individuals, which could influence the study results. Therefore, to minimise the risk of contamination and maintain the integrity of the clinical trial, participants were assigned to groups on a day-by-day basis. Participants who enrolled on specific days of the week were included in the experimental group, whilst those who enrolled on other days were included in the control group. The similarity of baseline characteristics between the groups will be assessed statistically.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Publich Health Nursing

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 12, 2026
• Study Start: February 25, 2024
• Primary Completion: December 30, 2025
• Study Completion: April 10, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)