]>
IRCT20241001063221N2 IRCT 2025-02-07 Assistant Researcher (Research and Technology) Urmia University of Medical Sciences Investigating the effect of virtual reality glasses on the intensity of pain and anxiety caused by hysterosalpingography of infertile women Investigating the effect of virtual reality glasses on the intensity of pain and anxiety caused by hysterosalpingography of infertile women 2025-02-20 anticipated 100 Complete https://irct.ir/trial/81081 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, 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. N/A Women undergoing hysterosalpingography. Intervention 1: 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. Intervention 2: Control group: Infertile women undergo hysterosalpingography only without receiving any intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Sarah Kazemzadeh
Diyanet Street
Urmia Iran (Islamic Republic of) 6257757168 +98 44 3348 4543 Samira_barjaste_70@yahoo.com Oroumia University of Medical Sciences scientific Samira Barjaste
Azadegan Street
Urmia Iran (Islamic Republic of) 6257757168 +98 44 3344 6085 Samira_barjaste_70@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Definite diagnosis of infertility (primary) by a gynecologist, First experience of hysterosalpingography, Age 18-49 years, Candidate for hysterosalpingography with infertility indication. 18 years 49 years Female History of seizures and epilepsy Impaired vision and hearing N97 Female infertility Treatment - Other N/A 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. Control group: Infertile women undergo hysterosalpingography only without receiving any intervention. 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. 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. Assistant Researcher (Research and Technology) Urmia University of Medical Sciences Approved 2024-12-11 Urmia University of Medical Sciences Ethics Committee Nazlu, Urmia University of Medical Sciences, Faculty of Nursing and Midwifery Urmia West Azarbaijan Iran (Islamic Republic of)