We expect that an HSG with use of Virtual Reality will decrease pain perception
ID
Bron
Verkorte titel
Aandoening
Infertility / tubal pathology
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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)
Achtergrond van het onderzoek
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
Doel van het onderzoek
We expect that an HSG with use of Virtual Reality will decrease pain perception
Onderzoeksopzet
Follow-up is 24 hours after HSG
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Women who:
- Will undergo an HSG with oil-based contrast for infertility
- Have no history of cervical procedures
- Speak Dutch or English
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9203 |
| Ander register | METc VUmc : 2020.0687 |