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IRCT20231013059702N2 IRCT 2024-02-11 Oroumia University of Medical Sciences Investigating the effect of Virtual Reality in intrauterine sperm insemination 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 2024-01-11 anticipated 114 Complete https://irct.ir/trial/75096 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Condition 1: Adjustment disorders (occurrence of worry, anxiety and depression following a special and critical situation in life). Condition 2: Reaction to extreme stress, unspecified (commonly seen in infertility). Condition 3: 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). Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data from hospital worry, anxiety and depression questionnaires and demographic questionnaire will be shared. When: Access to documents and data files starts six months after the publication of the article and results. To whom: 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. Conditions: 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). Where to obtain: 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. How to obtain: 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. Comments:
public Ghazaleh Gholami
Midwifery group, School of Nursing and Midwifery, Urmia University of Medical Sciences, Kilometer 11 Sero Road, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 4553 4222 ghazalehgholamii76@gmail.com Oroumia University of Medical Sciences scientific Ghazaleh Gholami
Midwifery group, School of Nursing and Midwifery, Urmia University of Medical Sciences, Kilometer 11 Sero Road, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 4553 4222 ghazalehgholamii76@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Female Infertility of male origin A candidate for treating infertility with methods other than intrauterine sperm insemination F43.2 F43.9 F42.0 Adjustment disorders Reaction to severe stress, unspecified Predominantly obsessional thoughts or ruminations Treatment - Devices Treatment - Devices 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. 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. 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. 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. 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. Oroumia University of Medical Sciences Approved 2024-01-10 Ethics Committee of Urmia University of Medical Sciences Midwifery group, School of Nursing and Midwifery, Urmia University of Medical Sciences, Kilometer 11 Sero Road, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)