Protocol summary

Study aim
Determining the effect of virtual reality on the severity of perceived hospital worry, anxiety and depression and the rate of pregnancy in women who are candidates for intrauterine sperm insemination.
Design
The clinical trial with intervention and control groups, single blind, randomized, on 114 patients, will be used for randomization by random allocation rule.
Settings and conduct
Location: Infertility Clinic, Kausar Hospital, Urmia . Methodology: completion of relevant questionnaires before and after the process of sperm transfer by all the people in the intervention and control groups, and the people in the intervention group benefited from virtual reality glasses with soothing content and images for 30 minutes together. Onesided blind study: selection of white envelopes with no name and sign determining the group with the presence of a person other than the researcher and leaving the participant unaware of the content inside the envelope.
Participants/Inclusion and exclusion criteria
Inclusion criteria: not having children at home, the first experience of treatment with intrauterine sperm insemination, infertility of female origin, not having vision, hearing and movement disorders. Exclusion and nonentry criteria are male infertility, refusal to continue participating in the research.
Intervention groups
Completion of hospital anxiety and depression and worry questionnaires by all participants before and after the sperm transfer process, the benefit of the intervention group for 20 minutes before the start of the transfer process and 10 minutes during the transfer from the virtual reality glasses and the benefit of the people The control group only received standard care
Main outcome variables
The possibility of reducing the severity of worry and hospital anxiety and depression and the possibility of increasing positive pregnancy test results after using virtual reality glasses.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231013059702N2
Registration date: 2024-02-11, 1402/11/22
Registration timing: registered_while_recruiting

Last update: 2024-02-11, 1402/11/22
Update count: 0
Registration date
2024-02-11, 1402/11/22
Registrant information
Name
Ghazaleh Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4553 4222
Email address
ghazalehgholamii76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-11, 1402/10/21
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Virtual Reality on perceived hospital anxiety, worry and depression and the rate of pregnancy in women who are candidates for intrauterine sperm insemination
Public title
Investigating the effect of Virtual Reality in intrauterine sperm insemination
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study Not having children at home The first treatment experience with sperm intrauterine insemination Infertility of female origin No physical illness Not having mental disorders and no history of drug use in the mental and psychological field No visual impairments No hearing disorders No movement disorders No addiction to smoking, drugs and alcohol The absence of stressful events in the last 6 months, such as the death of loved ones, accidents, etc
Exclusion criteria:
Infertility of male origin A candidate for treating infertility with methods other than intrauterine sperm insemination
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be of a limited type called random allocation law; First, 114 cards (numbered from 1 to 114) will be prepared for the total number of people under study; Group membership will be determined based on the removal of cards; It should be noted that these cards will be placed inside white envelopes without name and mark and the cards will be chosen by the participants in the presence of a person other than the researcher; The participant and the researcher will be unaware of the content inside the envelope ; Even numbers will be assigned in the intervention group and odd numbers in the control group ; Then the removed card will be discarded.
Blinding (investigator's opinion)
Single blinded
Blinding description
The cards identifying the groups of participants will be inside anonymous white envelopes and these cards will be chosen by the participants in the presence of a person other than the researcher ; The participant and the . researcher will be unaware of the content inside the envelope
Placebo
Not used
Assignment
Parallel
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
Midwifery group, School of Nursing and Midwifery, Urmia University of Medical Sciences, Kilometer 11 Sero Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
IR.UMSU.REC.1402.321

Health conditions studied

1

Description of health condition studied
Adjustment disorders (occurrence of worry, anxiety and depression following a special and critical situation in life)
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders

2

Description of health condition studied
Reaction to extreme stress, unspecified (commonly seen in infertility)
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified

3

Description of health condition studied
Dangerously obsessive thoughts or ruminations (which prevents the infertile person from going to the hospital to receive further treatment and can lead to more dangerous results for the person)
ICD-10 code
F42.0
ICD-10 code description
Predominantly obsessional thoughts or ruminations

Primary outcomes

1

Description
Worry score in the Pennsylvania Worry Questionnaire
Timepoint
Measuring people's level of concern using a questionnaire one hour before the start of the sperm transfer process into the uterus and half an hour after the sperm transfer process into the uterus
Method of measurement
Pennsylvania Anxiety Inventory

2

Description
Hospital anxiety and depression score in Zigmond and Snaith hospital anxiety and depression questionnaire
Timepoint
Measuring the level of anxiety and depression of people using a questionnaire one hour before the start of the sperm transfer process into the uterus and half an hour after the sperm transfer process into the uterus
Method of measurement
Zigmond and Snaith Hospital Anxiety and Depression Questionnaire

Secondary outcomes

1

Description
The percentage of people who have a positive or negative pregnancy test result
Timepoint
14 days after the sperm transfer process into the uterus
Method of measurement
Beta pregnancy blood test

Intervention groups

1

Description
Intervention group: People in the intervention group will complete the Pennsylvania anxiety and hospital anxiety and depression questionnaires by Sigmund and Snaith one hour before the sperm transfer process into the uterus and half an hour after the sperm transfer process. It should also be noted that these people will use virtual reality glasses that contain sounds and images of nature with soothing content for twenty minutes before the start of the sperm transfer process and for ten minutes during the sperm transfer process.
Category
Treatment - Devices

2

Description
Control group: People in the control group will complete the Pennsylvania anxiety and hospital anxiety and depression questionnaires by Sigmund and Snaith one hour before the start of the sperm transfer process into the uterus and half an hour after the sperm transfer process. It should be noted that the people of the control group will only benefit from the conditions, training and standard care of the respective center.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Kausar Medical Training Center (the infertility clinic )in Urmia
Full name of responsible person
Ghazaleh Gholami
Street address
Kausar Women's Comprehensive Hospital., Ayatollah Hasani St
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 1466
Email
research@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Midwifery group, School of Nursing and Midwifery, Urmia University of Medical Sciences, Kilometer 11 Sero Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
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
Ghazaleh Gholami
Position
Senior professional student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Midwifery group, School of Nursing and Midwifery, Urmia University of Medical Sciences, Kilometer 11 Sero Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 4553 4222
Fax
Email
ghazalehgholamii76@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ghazaleh Gholami
Position
Senior professional student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Midwifery group, School of Nursing and Midwifery, Urmia University of Medical Sciences, Kilometer 11 Sero Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 4553 4222
Fax
Email
ghazalehgholamii76@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ghazaleh Gholami
Position
Senior professional student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Midwifery group, School of Nursing and Midwifery, Urmia University of Medical Sciences, Kilometer 11 Sero Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 4553 4222
Fax
Email
ghazalehgholamii76@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data from hospital worry, anxiety and depression questionnaires and demographic questionnaire will be shared.
When the data will become available and for how long
Access to documents and data files starts six months after the publication of the article and results.
To whom data/document is available
The obtained data will be accessible to researchers working in academic and scientific institutions, as well as people working in the relevant industry, from the time of access to them.
Under which criteria data/document could be used
The data will be provided to the mentioned people for further guidance in conducting similar studies (for example, the use of an intervention similar to virtual reality in the field of infertility or the use of virtual reality glasses in other fields other than infertility).
From where data/document is obtainable
Dear applicants, they can send more information to the email address: ghazalehgholamii76@gmail.com or postal address: Bostan Girls Student Dormitory, Zakir Street ,Apadana Crossroads, Shahid Bahonar Highway, Urmia by zip code:6257757168 or contact number : 0098 09909358804 (respondent: Ghazaleh Gholami) refer.
What processes are involved for a request to access data/document
Applicants for documents can contact the respondent through one of the mentioned communication channels, And after stating their reasons for requesting documents, The necessary information will be provided to them within a maximum period of one week.
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