Endometrial Cancer, Endometrial Diseases, Endometrial Hyperplasia, Myoma;Uterus
Conditions
Keywords
Outpatient Hysteroscopy, Virtual Reality Technology, Pain and Anxiety Management, See & Treat
Brief summary
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.
Interventions
DEVICEUse of virtual reality during the hysteroscopic procedure
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.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate (RR) during procedure | 5 minutes after the start of the procedure | Respiratory rate (RR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria). |
| Anxiety post procedure | 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. |
| Heart rate (HR) pre procedure | 1 minute before the procedure | Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria). |
| Respiratory rate (RR) pre procedure | 1 minute before the procedure | Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria). |
| Heart rate (HR) during procedure | 5 minutes after the start of the procedure | Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria). |
| Pain pre procedure | 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. |
| Anxiety pre procedure | 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. |
| Pain post procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of procedure | During procedure | Recording the time of procedure |
| Satisfaction rate | 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) |
| Side effects | 5 minutes after the procedure | Reported side effects |
| Suspension rate of procedure | During procedure | Procedure completion and suspension rate (defined as the proportion of suspended procedures for any reasons) |
Countries
Italy
Outcome results
None listed