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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Experimental | The patients in this group undergo the procedure using virtual reality. |
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| Control group | No Intervention | The patients in this group undergo the procedure without the use of virtual reality. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain pre 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. | 1 minute before the procedure |
| Anxiety pre 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. | 1 minute before the procedure |
| Pain post 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. | 1 minute after the procedure |
| Anxiety post 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. | 1 minute after the procedure |
| Heart rate (HR) pre procedure | Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria). | 1 minute before the procedure |
| Respiratory rate (RR) pre procedure | Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria). |
| Measure | Description | Time Frame |
|---|---|---|
| Suspension rate of procedure | Procedure completion and suspension rate (defined as the proportion of suspended procedures for any reasons) | During procedure |
| Time of procedure | Recording the time of procedure |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Brunella Ms Zizolfi, AssProfessor | University Federico II of Naples - Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Naples | 810131 | Italy |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D014591 | Uterine Diseases |
| D047708 | Myofibroma |
| D004714 | Endometrial Hyperplasia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 1 minute before the procedure |
| Heart rate (HR) during procedure | Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria). | 5 minutes after the start of the procedure |
| Respiratory rate (RR) during procedure | Respiratory rate (RR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria). | 5 minutes after the start of the procedure |
| During procedure |
| Satisfaction rate | Satisfaction rate (Virtual reality group: desire to use the headset again in the future / Control group: desire to use headset if they could) | 5 minutes after the procedure |
| Side effects | Reported side effects | 5 minutes after the procedure |
| D009369 |
| Neoplasms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |