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Completed

NCT Number: NCT06463210

Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy

The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).

60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.

The intervention in the study group was to use a virtual reality (VR) device (Meta Quest2) as a distraction technique during the OH.

The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH

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Key information

Conditions

Pain, Acute Acute Pain Behavior Health Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Satisfaction, Patient Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

About this study

The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).

60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.

In the standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.

The standard care group had a trained nurse providing distraction and emotional support.

The study group had a VR device (Meta Quest 2) with a video consisting of a gondola ride through the canals of Venice with relaxing music played on the headset The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH, comparing it with the standard care group.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Consecutive women candidates to undergo an OH
  • Women aged 18 to 70 years old

Exclusion criteria

  • Visual impairment
  • Hearing impairment
  • Language barrier impeding the correct explanation of the study
  • Contraindication for using the VR device
  • Confirmed malignant endometrial disease
  • Anatomical characteristics impeding the office hysteroscopy

Treatment and study plan

Virtual reality as a distraction technique

Device

A 360º relaxing video with music was displayed through a VR headset

Primary outcomes

  1. Peak pain

    Time frame: 5-10 minutes after the procedure

    a Visual analogue score (VAS score) between 0 and 10, patients reported their peak perceived pain during the procedure, being 0 no pain and 10 worst pain imaginable

  2. Mean pain

    Time frame: 5-10 minutes after the procedure

    a VAS score between 0 and 10, patients reported their mean perceived pain during the procedure worst pain imaginable

Secondary outcomes

  1. Patient satisfaction with the information received

    Time frame: 5-10 min before the procedure

    Prior to the OH all patients were interrogated about their perception of the information received about the procedure through the question "How has been the information received about the procedure?" (Not enough/Normal/Very good

  2. Patient overall satisfaction with the procedure (OH)

    Time frame: 5-10 min after the procedure

    Overall satisfaction with the OH was assessed through a question formulated as follows: "What is your level of satisfaction with the hysteroscopic procedure?", where patients could evaluate their opinion on a 5-point scale (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied

  3. Patient satisfaction with the VR intervention

    Time frame: 5-10 min after the procedure

    On the study group, patient satisfaction with the VR intervention was also assessed with the following 5-point scale satisfaction question "What is your level of satisfaction with the VR intervention? (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied

  4. Patient satisfaction with the VR intervention

    Time frame: 5-10 min after the procedure

    Patients on the VR group were also asked whether they would like to use the VR if they need to undergo another OH in the future (Yes/No)

Sponsors and collaborators

Lead sponsor

Hospital Universitario 12 de Octubre

Other

Registry information

Official study title

Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 17, 2024
Registry last updated
Jul 5, 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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