Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?

• Sponsor: Peter Humaidan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05826938
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

A non-pharmacological, non-blinded, randomized cohort study that will investigate the effect of Virtual Reality technology on the patient experience during oocyte retrieval.

The primary objective of the trial is to investigate the impact of Virtual Reality technology on the patient experience

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Device: Virtual reality technology	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?
• Actual Study Start Date: Mar 13, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 13, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual reality The intervention group receives stimuli in the form of Virtual Reality technology before and during oocyte retrieval. In addition, patients receive standard treatment	Device: Virtual reality technology; Participants who are randomized to group 1 will receive the Virtual Reality glasses on the day of oocyte retrieval in the recovery room. The participant chooses which animation she wants to experience.
No Intervention: Control The control group, does not receive stimuli in the form of Virtual Reality technology, but only the standard treatment

Outcome Measures

Primary Outcome Measures

1. Questionnaires regarding impact on patient experience [30-60 minutes]

   The impact of Virtual Reality technology on the patient experience during oocyte retrieval through questionnaires. A visual analog scale (VAS) from 1-10 will be used for this measurement.

Secondary Outcome Measures

1. Questionnaires reagarding the impact on the consumption of analgesic medication [30-60 minutes]

   The effect of Virtual Reality technology on the consumption of analgesic medication. A visual analog scale (VAS) from 1-10 will be used for this measurement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women undergoing oocyte retrieval

• Understanding and speaking Danish

Exclusion Criteria:

• Previous participation in the trial

• Acupuncture as pain relief during oocyte retrieval

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fertility Clinic Skive, Skive Regional Hospital	Skive		Denmark	7800

Sponsors and Collaborators

• Peter Humaidan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Humaidan, Professor, Consultant, Regionshospitalet Viborg, Skive
• ClinicalTrials.gov Identifier: NCT05826938
• Other Study ID Numbers: Virtual Reality-project
• First Posted: Apr 24, 2023
• Last Update Posted: Apr 28, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter Humaidan, Professor, Consultant, Regionshospitalet Viborg, Skive: Infertility; Virtual reality
• Additional relevant MeSH terms: Infertility; Infertility, Female

Study Results

No Results Posted as of Apr 28, 2023