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OpenTrials
Completed

NCT Number: NCT04466956

Virtual Reality in MVA for Miscarriage

We are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration.

Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic equipment. In this study a VR headset is worn by the patient allowing them to experience a relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed.

VR is mostly used in computer gaming but has uses in medical field and has been used in the treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain. However, its role in the management of pain and anxiety during gynaecological procedures like manual vacuum aspiration has not been researched. This study explores whether it has a place in the treatment of gynaecological pain and reduction of anxiety.

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Key information

Conditions

Miscarriage Abortion, Spontaneous Anxiety Disorders Female Urogenital Diseases and Pregnancy Complications Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

North Middlesex University Hospital, London, United Kingdom

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About this study

Many simple gynaecological procedures can be performed in an outpatient setting without the need for general anaesthesia. Such office-based procedures include outpatient hysteroscopy, endometrial biopsy, large-loop-excision of the transformation zone and manual vacuum aspiration for the management of miscarriage. Advantages experienced by patients include reduced anaesthetic risk, enhanced recovery time and flexibility of timings. For the healthcare provider there are significant cost benefits on the basis of reduced theatre time, staff and equipment. Patient satisfaction is generally high but influenced by their experience of pain and feelings of anxiety before, during and after the procedure.

The rationale for this study is to invetsigate the role of distraction techniques and the feasibility of using virtual reality for the management of acute pain and anxiety experienced by patients undergoing manual vacuum aspiration

Primary objective

  • Feasibility of using virtual reality as a distraction technique in management of acute pain and anxiety in patients undergoing manual vacuum aspiration for miscarriage.

Secondary objectives

  • Understanding the acceptability and effectiveness of VR interventions in office gynaecology procedures
  • Understanding the factors that might influence the willingness of patients to participate in a future formal trial of the technology.
  • Understanding how best to implement the technology and designing of the contents of the VR intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients: Clinical indications for undergoing an MVA will be confirmed. Inclusion criteria will include all women of 18 - 50 years of age, planned for a MVA who are able and willing to give informed consent.

Exclusion criteria

  • Hearing impairments and blindness
  • History of epilepsy or any previous seizures
  • Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conisation)
  • Any known characteristics that make the patient unsuitable for undergoing MVA (e.g. known bleeding disorder, gestation >12 weeks)
  • The denial or withdrawal of informed consent

Treatment and study plan

Virtual reality

Device

Virtual reality headset worn with short relaxing video played during MVA procedure

Primary outcomes

  1. Anxiety Rating

    Time frame: 12 months

    Anxiety score (numerical rating score 0 least-10 worst) and questionnaire

  2. Pain Rating

    Time frame: 12 months

    Pain score (numerical rating score 0 least-10 worst) and questionnaire

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • North Middlesex University Hospital NHS Trust

Registry information

Official study title

Virtual Reality as a Distraction Technique for the Management of Acute Pain and Anxiety During Manual Vacuum Aspiration for Miscarriage

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 10, 2020
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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