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Completed

NCT Number: NCT06524934

Virtual Reality's Role in See&Treat Hysteroscopy

The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see & treat philosophy.

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Key information

Conditions

Endometrial Cancer Connective Tissue Diseases Endometrial Diseases Endometrial Hyperplasia Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Myofibroma Myoma;Uterus Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, 810131, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Exclusion criteria

-

Treatment and study plan

Use of virtual reality during the hysteroscopic procedure

Device

In VR group patients underwent hysteroscopy with standard care but the addition of VRT provided by a VR headset and headphones with the use of a Hypno VR software.

Primary outcomes

  1. Pain pre procedure

    Time frame: 1 minute before the procedure

    Level of pain the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain to 10 corresponding to the worst pain (subjective criteria), before undergoing diagnostic and operative procedures.

  2. Anxiety pre procedure

    Time frame: 1 minute before the procedure

    Level of anxiety the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no anxiety to 10 corresponding to the worst anxiety (subjective criteria), before undergoing diagnostic and operative procedures.

  3. Pain post procedure

    Time frame: 1 minute after the procedure

    Level of pain reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst pain (subjective criteria), during diagnostic and operative procedures.

  4. Anxiety post procedure

    Time frame: 1 minute after the procedure

    Level of anxiety reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst anxiety (subjective criteria), during diagnostic and operative procedures.

  5. Heart rate (HR) pre procedure

    Time frame: 1 minute before the procedure

    Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).

  6. Respiratory rate (RR) pre procedure

    Time frame: 1 minute before the procedure

    Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).

  7. Heart rate (HR) during procedure

    Time frame: 5 minutes after the start of the procedure

    Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).

  8. Respiratory rate (RR) during procedure

    Time frame: 5 minutes after the start of the procedure

    Respiratory rate (RR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).

Secondary outcomes

  1. Suspension rate of procedure

    Time frame: During procedure

    Procedure completion and suspension rate (defined as the proportion of suspended procedures for any reasons)

  2. Time of procedure

    Time frame: During procedure

    Recording the time of procedure

  3. Satisfaction rate

    Time frame: 5 minutes after the procedure

    Satisfaction rate (Virtual reality group: desire to use the headset again in the future / Control group: desire to use headset if they could)

  4. Side effects

    Time frame: 5 minutes after the procedure

    Reported side effects

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

The Impact of Virtual Reality Technology in the Era of See & Treat Hysteroscopy: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Jul 29, 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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