Determining the effect of virtual reality glasses on the severity of pain and anxiety caused by hysterosalpingography in infertile women
Design
A randomized, controlled clinical trial with parallel groups on 100 infertile women, using a simple randomization method for randomization. The study is not blinded.
Settings and conduct
The samples will be selected conveniently at the clinic of the Kausar Educational and Therapeutic Center in Urmia and will be randomly assigned to two intervention and control groups using a block-based randomization method. Then, the virtual reality headset will be provided to the intervention group for 20 minutes during the sampling of infertile women, and the control group will receive routine care. The study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Definite diagnosis of (primary) infertility by a gynecologist,
2- First experience with hysterosalpingography,
3- Age 18-49 years,
4- Candidate for hysterosalpingography with infertility indication,
5- Willingness to participate in the study.
Exclusion criteria:
1- History of seizures and epilepsy,
2- Impaired vision and hearing.
Intervention groups
Group 1 (control) also underwent hysterosalpingography without any intervention. Group 2 (intervention) was given virtual reality glasses at the same time as hysterosalpingography. The game was called Smiling Snowmen, which was designed in 20 minutes and 5 stages. This game can be played using virtual reality glasses.
Main outcome variables
Severity of pain and anxiety caused by hysterosalpingography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241001063221N2
Registration date:2025-02-07, 1403/11/19
Registration timing:prospective
Last update:2025-02-07, 1403/11/19
Update count:0
Registration date
2025-02-07, 1403/11/19
Registrant information
Name
Leila Aghdami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3484 5433
Email address
sry.aliaghdami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-20, 1403/12/02
Expected recruitment end date
2025-05-20, 1404/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of virtual reality glasses on the intensity of pain and anxiety caused by hysterosalpingography of infertile women
Public title
Investigating the effect of virtual reality glasses on the intensity of pain and anxiety caused by hysterosalpingography of infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of infertility (primary) by a gynecologist,
First experience of hysterosalpingography,
Age 18-49 years,
Candidate for hysterosalpingography with infertility indication.
Exclusion criteria:
History of seizures and epilepsy
Impaired vision and hearing
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly assigned to the intervention and control groups by a non-researcher who is unaware of the allocation. In order to minimize contact between groups, the first person to volunteer each day to participate in the study determines the type of group for that day. The first participant selects one of the balls from a bag containing balls A-B-C-D. If the first participant selects ball A or C that day, they enter the intervention group and all participants are placed in the intervention group that day. If the first participant selects ball B or D that day, all participants are placed in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences Ethics Committee
Street address
Nazlu, Urmia University of Medical Sciences, Faculty of Nursing and Midwifery
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Approval date
2024-12-11, 1403/09/21
Ethics committee reference number
IR.UMSU.REC.1403.300
Health conditions studied
1
Description of health condition studied
Women undergoing hysterosalpingography
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Severity of pain caused by hysterosalpingography
Timepoint
The pain intensity scale will be used immediately after the completion of hysterosalpingography in the two control and intervention groups.
Method of measurement
Visual Pain Scale
Secondary outcomes
1
Description
Severity of anxiety caused by hysterosalpingography
Timepoint
The anxiety scale will be used before and immediately after the completion of hysterosalpingography in both the control and intervention groups.
Method of measurement
Spielberger Overt Anxiety Scale
Intervention groups
1
Description
Intervention group: Virtual reality glasses will be provided to the intervention group at the beginning of the hysterosalpingography for 20 minutes. The virtual reality game, which is designed and developed by experienced experts in the field of virtual reality, is a game in which the most important point in its construction is the implementation of a snowy and white space that conveys a sense of peace. This game is played using virtual reality glasses. Therefore, its tools are a three-dimensional display similar to a combination of large glasses with a helmet. It has two very small monitors that cover a wide field of view and provide adequate visual input in such a way that the individual does not see anything other than the space of his eyes and can easily view the images in it. On the display, in the area of each ear, there are two speakers with sound reproduction and also enter the individual into the virtual environment through sound. On the glasses, there is a head-tracking sensor that signals the user's head movements from the top of the helmet to the computer, and the user can change their viewing angle by shaking their head. At first, the game guide explains to the women that to start the game and aim, they must move their head to place the red dot in front of their eyes on the word start. The main character moves forward in this space. This character can move in any direction in space. After a while, some smiling snowmen would arrive and the person would aim and throw snowballs at the snowmen approaching from the surrounding area. With each correct shot, a point would be added to the user's score, and if a ball was not thrown at the snowman and the player passed by it, he would lose the chance to gain points from it and the snowman would melt. Then this game does not have a loser and therefore does not bring negative emotions with it. Finally, the player's record, which is his evaluation criterion and motivating factor, is recorded.
Category
Treatment - Other
2
Description
Control group: Infertile women undergo hysterosalpingography only without receiving any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kausar Educational and Medical Center
Full name of responsible person
Sarah Kazemzadeh
Street address
Diyant Street
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 914 447 0621
Email
samira_barjaste_70@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Assistant Researcher (Research and Technology) Urmia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
saber@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Assistant Researcher (Research and Technology) Urmia University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sarah Kazemzadeh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Diyanet Street
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 44 3348 4543
Email
Samira_barjaste_70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Samira Barjaste
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Azadegan Street
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 44 3344 6085
Email
Samira_barjaste_70@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sarah Kazemzadeh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Dianat Street
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 44 3348 4543
Email
Samira_barjaste_70@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available