Determining the effect of game therapy based on virtual reality on the intensity of anxiety and pain from colposcopy in women with Human Papilloma Virus
Design
A clinical trial with a control group, with parallel groups, randomized, on 100 women infected with Human Papilloma Virus, simple random method was used for randomization.
Settings and conduct
The samples will be selected as available in the clinic of Kausar Urmia Oozashi Therapy Center and will be allocated to two intervention and control groups by random block method. Then, the virtual reality headset will be provided to the people of the intervention group for 20 minutes while taking samples from Women with Human Papilloma Virus, and the control group will receive the usual care.
Participants/Inclusion and exclusion criteria
Definitive confirmation of Human Papilloma Virus infection , Age of patients 18 to 45 years old ,Having minimum literacy, Not having vision and hearing defects, Not having chronic disease before or during treatment.
Intervention groups
Group A (intervention) is given virtual reality glasses at the same time as colposcopy. The game called smiling snowmen is designed in 20 minutes and 5 stages. This game can be played with virtual reality glasses.
Control B (group) the patients only undergo colposcopy without receiving any intervention.
Main outcome variables
Severity of pain and anxiety caused by colposcopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241001063221N1
Registration date:2024-11-27, 1403/09/07
Registration timing:prospective
Last update:2024-11-27, 1403/09/07
Update count:0
Registration date
2024-11-27, 1403/09/07
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
2025-01-09, 1403/10/20
Expected recruitment end date
2025-04-20, 1404/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of virtual reality-based game therapy on anxiety and pain caused by colposcopy in women with Human Papilloma Virus (HPV)
Public title
Investigating the effect of virtual reality-based game therapy on anxiety and pain caused by colposcopy in women with Human Papilloma Virus (HPV)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1.Definite confirmation of Human Papilloma Virus (HPV) ,
2.willingness to participate in the study,
3.having minimal reading and writing skills.
Exclusion criteria:
1. Participant's unwillingness to continue cooperation during each stage of the study,
2. History of seizures and epilepsy, dizziness and active vomiting,
3. Absence of vision and hearing disorders,
4. Absence of chronic diseases before or during treatment.
Age
From 18 years old to 45 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
People are placed in two intervention and control groups by a simple random allocation method by a non-researcher who is unaware of the divisions. Thus, to minimize contact between groups, each day the first person who volunteers to participate in the study determines the type of group for that day. In this way, the first participant chooses one of the balls from the bag that contained balls A-B-C-D, that day if the first participant chooses ball A or C, he enters the intervention group and that day all the participants in They are placed in the intervention group, and if the first participant chooses ball B or D, then all the participants will enter 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
Ethics Committee of Urmia University of Medical Sciences
Street address
Nazlu, Urmia University of Medical Sciences, Faculty of Nursing and Midwifery
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Approval date
2024-09-29, 1403/07/08
Ethics committee reference number
IR.UMSU.REC.1403.199
Health conditions studied
1
Description of health condition studied
Women undergoing colposcopy
ICD-10 code
R87.810
ICD-10 code description
Cervical high risk human papillomavirus (HPV) DNA test positive
Primary outcomes
1
Description
Severity of anxiety and pain caused by colposcopy
Timepoint
Measuring anxiety caused by colposcopy before colposcopy and measuring anxiety caused by colposcopy and pain intensity after colposcopy.
Method of measurement
Spielberger manifest anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Virtual reality glasses will be provided to the intervention group during colposcopy for 20 minutes. The virtual reality game, which was designed and made by experienced experts in the field of virtual reality, is a game in which the most important point in its creation is the implementation of a snowy and white space that conveys a sense of peace. This game is played by virtual reality glasses. Therefore, its tools are a three-dimensional display similar to a combination of big glasses with a hat. There are two very small monitors in it, which covers a wide field of vision and provides adequate visual input in such a way that a person does not see anywhere else except his own eye space and can easily view images in it. There are two speakers on the screen in both ears, and it brings the person into the virtual environment from the sound point of view. On the glasses, there is a head motion detector sensor that signals the user's head movements from the top of the helmet to the computer, and the user can change the angle of vision by shaking his head. At first, in the game guide, it is explained to women that to start the game and aim, they must place the red dot in front of their eyes on the word start by moving their head. The main character moves forward in this space. This character can move in any direction in the space. Some time after the start of the game, smiling snowmen would arrive and the person would point and throw snowballs at the opposite snowmen who were coming towards him from around. By marking each snowman correctly, the user's score is added, and if a bullet is not thrown at the snowman and the player passes it, he loses the chance to score and the snowman melts. So this game has no loss and for this reason it does not carry negative emotions. At the end, the player's record, which is his evaluation criterion and motivating factor, is recorded. Finally, after the completion of colposcopy in both groups, the visual pain scale is shown to the participants and its score is recorded, and the situational anxiety questionnaire is completed again for both groups.
Category
Treatment - Other
2
Description
Control group: patients only undergo colposcopy without receiving any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kausar educational and therapeutic center
Full name of responsible person
Leila Ali Aghdami
Street address
Imam Reza St
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 914 447 0621
Email
leila_aghdami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research (Research and Technology) of Urmia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Resalat Blvd
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
Vice President of Research (Research and Technology) of 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
Leila Ali Aghdami
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Imam Reza St
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 44 3348 4543
Email
leila_aghdami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Leila Ali Aghdami
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Imam Reza St
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 44 3348 4543
Email
leila_aghdami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Leila Ali Aghdami
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Imam Reza St
City
Urmia
Province
West Azarbaijan
Postal code
6257757168
Phone
+98 44 3348 4543
Email
leila_aghdami@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