Infertility, Vaginal Blood Loss
Conditions
Keywords
Hysteroscopy, VR, Vurtual reality
Brief summary
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy in the outpatient setting.
Detailed description
A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo operative hysteroscopy either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.
Interventions
DEVICESootheVR: AppliedVR, Los Angeles, California
a head-mounted display
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* . Women with suspected infection * women considered not suitable to undergo an office hysteroscopy * women who reported the use of analgesia 6 hours prior to the procedure.
Exclusion criteria
* patient needed office hysteroscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessments of pain through physiological parameters | 10 minutes | Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute. |
| Assessments of pain through pain score parameter | 10 minutes | Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety. |
Countries
Israel
Outcome results
None listed