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Virtual Reality ter pijnverlichting bij hysterosalpingografie

Virtual Reality for pain relief in hysterosalpingography

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28038
Enrollment
134
Registered
2021-01-16
Start date
2021-01-19
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility / tubal pathology

Interventions

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 be

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactKimmy Rosielle

Amsterdam UMC

k.rosielle@amsterdamumc.nl020-4444567

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)