No registrations found.
ID
Source
Brief title
Health condition
Infertility / tubal pathology
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is pain during the HSG. This measure consists of two components: the most severe pain (using a visual analogue scale 0-10) and the overall pain (using a visual analogue scale 0-10)
Secondary outcome
Secondary endpoints are:
- (Hypothetical) willingness to undergo another HSG if necessary
- Use of oral analgesics during the first 24 hours after the HSG
- ‘Immersiveness’ in the VR program
- Side effects of the VR program
Background summary
Aim: The aim of this study is to investigate whether the use of Virtual Reality can reduce pain during HSG.
Study Design: Single center randomized controlled trial
Study population: Women undergoing an HSG with oil-based contrast for insubfertility.
Intervention: Virtual Reality with the use of a ‘head mounted device’ (Sync VR Medical, Utrecht, The Netherlands) during the HSG. Participants will receive a demo of the VR device prior to the HSG and can choose between different relaxing and distracting modules. Questionnaires will be administered before and after the HSG.
Main study parameters: The primary endpoint is pain during the HSG. This measure consists of two components: the most severe pain (using a visual analogue scale 0-10) and the overall pain (using a visual analogue scale 0-10).
Secondary endpoints are:
- (Hypothetical) willingness to undergo another HSG if necessary
- Use of oral analgesics during the first 24 hours after the HSG
- ‘Immersiveness’ in the VR program
- Side effects of the VR program
Study objective
We expect that an HSG with use of Virtual Reality will decrease pain perception
Study design
Follow-up is 24 hours after HSG
Intervention
Virtual Reality with the use of a ‘head mounted device’ (Sync VR Medical, Utrecht, The Netherlands) during the HSG. Participants will receive a demo of the VR device prior to the HSG and can choose between different relaxing and distracting modules.
Inclusion criteria
Women who:
- Will undergo an HSG with oil-based contrast for infertility
- Have no history of cervical procedures
- Speak Dutch or English
Exclusion criteria
Women who:
- Are on chronic pain medication
- Use antidepressants or sedatives
- Underwent an HSG before
- Are unwilling or unable to give ‘informed consent’
- Are pregnant
- Have a malignancy
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9203 |
| Other | METc VUmc : 2020.0687 |