NCT05826938

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2024

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

March 8, 2023

Last Update Submit

April 26, 2023

Conditions

Infertility, Female

Keywords

InfertilityVirtual reality

Outcome Measures

Primary Outcomes (1)

  • Questionnaires regarding impact on patient experience

    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.

    30-60 minutes

Secondary Outcomes (1)

  • Questionnaires reagarding the impact on the consumption of analgesic medication

    30-60 minutes

Study Arms (2)

Virtual reality

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group, does not receive stimuli in the form of Virtual Reality technology, but only the standard treatment

Interventions

Virtual reality technologyDEVICE

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.

Virtual reality

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing oocyte retrieval
  • Understanding and speaking Danish

You may not qualify if:

  • Previous participation in the trial
  • Acupuncture as pain relief during oocyte retrieval

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic Skive, Skive Regional Hospital

Skive, 7800, Denmark

RECRUITING

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Consultant

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 24, 2023

Study Start

March 13, 2023

Primary Completion

March 1, 2024

Study Completion

March 13, 2024

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

DK(1)