Back to resultsCan Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?
Primary Purpose
Infertility, Female
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Virtual reality technology
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring Infertility, Virtual reality
Eligibility Criteria
Inclusion Criteria: Women undergoing oocyte retrieval Understanding and speaking Danish Exclusion Criteria: Previous participation in the trial Acupuncture as pain relief during oocyte retrieval
Sites / Locations
- Fertility Clinic Skive, Skive Regional HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual reality
Control
Arm Description
The intervention group receives stimuli in the form of Virtual Reality technology before and during oocyte retrieval. In addition, patients receive standard treatment
The control group, does not receive stimuli in the form of Virtual Reality technology, but only the standard treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Questionnaires reagarding the impact on the consumption of analgesic medication
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05826938
Brief Title
Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?
Official Title
Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Humaidan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Infertility, Virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
The intervention group receives stimuli in the form of Virtual Reality technology before and during oocyte retrieval. In addition, patients receive standard treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group, does not receive stimuli in the form of Virtual Reality technology, but only the standard treatment
Intervention Type
Device
Intervention Name(s)
Virtual reality technology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Questionnaires regarding impact on patient experience
Description
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.
Time Frame
30-60 minutes
Secondary Outcome Measure Information:
Title
Questionnaires reagarding the impact on the consumption of analgesic medication
Description
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.
Time Frame
30-60 minutes
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women undergoing oocyte retrieval
Understanding and speaking Danish
Exclusion Criteria:
Previous participation in the trial
Acupuncture as pain relief during oocyte retrieval
Facility Information:
Facility Name
Fertility Clinic Skive, Skive Regional Hospital
City
Skive
ZIP/Postal Code
7800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Humaidan, DMSc
Phone
+4578445760
Email
fertilitetsklinikken@midt.rm.dk
12. IPD Sharing Statement
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Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?
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