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IRCT20230209057367N1 IRCT 2023-04-26 Iranian academic center for education culture and research Designing a Mindfulness-Based Cognitive Therapy Program in Virtual Reality Environment and Comparison of its Effectiveness with Traditional Mindfulness-Based Cognitive Therapy on Rumination, Cognitive Emotion Regulation, and Pain Perception Symptoms in Elderly. Designing a Mindfulness-Based Cognitive Therapy Program in Virtual Reality Environment and Comparison of its Effectiveness with Traditional Mindfulness-Based Cognitive Therapy on Rumination, Cognitive Emotion Regulation, and Pain Perception Symptoms in Elderly. 2023-05-05 anticipated 45 Complete https://irct.ir/trial/68715 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The primary objective of this study is to develop a software package utilizing real scenes and videos of nature, incorporating virtual reality (VR) technology and 360-degree videos. The VR experience will be delivered through a smartphone equipped with a gyroscope and a VR headset, enabling participants to view the nature-based movies in an immersive manner. This innovative approach will allow for a realistic and immersive experience of nature within a controlled experimental setting, providing a novel way to investigate the effects of nature exposure on various outcomes, Randomization description: A simple randomization method will be employed in this research, with the individual as the randomization unit. Participants who meet the eligibility criteria will be randomly assigned to one of the three study groups, which include traditional cognitive therapy based on mindfulness presence, cognitive therapy based on mindfulness presence in a virtual reality environment, and a control group. Randomization will be performed using a table of random numbers, and opaque sealed envelopes with a random sequence will be used for concealment. The random numbers obtained will be written on the envelopes, and on the day of group assignment, the envelopes will be opened to determine the group assigned to each participant. This method of randomization and concealment aims to minimize bias and ensure an unbiased allocation of participants to the study groups. N/A Condition 1: Rumination in the elderly. Condition 2: Problem in the cognitive emotion regulation in the elderly. Condition 3: perceived pain in the elderly. Intervention 1: Intervention group: Group 1. Participants in this group receive a traditional mindfulness-based cognitive therapy intervention. The intervention is conducted in a group format, consisting of eight treatment sessions held once a week, with each session lasting 90 minutes. The intervention includes various mindfulness techniques, such as focused breathing, body scanning, acceptance, recognizing thoughts as mental events, and increasing awareness of thoughts and bodily sensations. Intervention 2: Intervention group: Group 2. Participants in this group receive an intervention that includes virtual reality videos. The intervention begins with mindfulness exercises followed by watching virtual reality movies through a headset. After removing the headset, the therapist provides additional training. This intervention is implemented over eight sessions, with each session lasting 90 minutes, conducted once per week. Intervention 3: Control group: Participants in this group will complete the questionnaires at three time points: pre-test, post-test, and follow-up. The participants in the control group will be placed on a waiting list, and after the intervention of the experimental group, to adhere to ethical considerations, the intervention will also be provided to the control group. Yes - There is a plan to make this available What will be shared: The data in this study consists of raw data and findings after statistical analysis. The first set of data is obtained from participant scores on questionnaires, which can be published after removing private information through an Excel file. The main research data, including descriptive tables, normality, post hoc tests, and analysis of variance with repeated measurements, is presented after statistical analysis using SPSS software version 25. The study protocol, which includes a detailed description of the intervention sessions in the experimental groups, will be shared as a Word file. The clinical study report will outline the method of conducting the research and will be published in the same format as compiled in the thesis. The informed consent form will also be published after de-identifying participants and removing personal information. When: The beginning of the access period is in September 2023. To whom: All people who work in the field of aging have the possibility to access the data. including researchers, policy makers and statesmen and people who work in the field of innovation, technology and making assistive devices for the elderly. Conditions: The data obtained from this research can be utilized for planning and implementing health solutions for the elderly. However, it should be noted that due to the influence of time and place on research results, caution should be exercised in generalizing the findings to elderly populations in other cultures. To request access to the data, the following conditions must be met: Submission of an introduction letter from a reputable institution or company The researcher or student must provide details about the university and field of study Introduction of the project and sponsoring institution (for industry-related research) Where to obtain: To receive data and documents, you can contact the researcher's email address: nasibehsar@gmail.com Or refer to the Research Vice-Chancellor of Yazd University of Science and Art: Yazd, Student Blvd., University of Science and Art (035) 38264080-9 (035) 38302184 89167-13335 info@sau.ac.ir How to obtain: To obtain the necessary documents, please send an email to the researcher clearly expressing your request. Once the email has been checked and approved by the researcher, the requested documents will be sent to the applicant within two weeks. Comments:
public Nasibeh Sarrami Foroushani
Daneshjoo Blvd., University of Science and Art
Yazd Iran (Islamic Republic of) ۸۹۱۶۷-۱۳۳۳۵ +98 35 3826 4080 nasibehsar@gmail.com Iranian academic center for education culture and research scientific Nasibeh Sarrami Foroushani
Daneshjoo Blvd., University of Science and Art
Yazd Iran (Islamic Republic of) 8419135941 +98 31 3364 2072 nasibehsar@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) Participants with normal visual acuity and hearing abilities will be included in the study to ensure an accurate perception of the interventions and assessments Participants who are literate in reading and writing will be included, as the study will involve written instructions, assessments, and interventions that require these skills. Participants with no history of serious psychiatric and psychological disorders, as assessed through self-report and/or clinical evaluation. Participants with no history of physical diseases, epilepsy, or cybersickness disease, as assessed through medical records and self-report. Age over 60 60 years no limit Female Participants with a history of psychiatric treatment, including hospitalization, psychotherapy, or psychotropic medication use, will be excluded, as this may confound the results and impact the effectiveness of the interventions. Participants with a history of cognitive disorders such as Alzheimer's disease, mild cognitive impairment, or Parkinson's disease, as diagnosed by medical records and/or clinical evaluation, will be excluded. F42.0 Predominantly obsessional thoughts or ruminations Treatment - Other Treatment - Other Treatment - Other Intervention group: Group 1. Participants in this group receive a traditional mindfulness-based cognitive therapy intervention. The intervention is conducted in a group format, consisting of eight treatment sessions held once a week, with each session lasting 90 minutes. The intervention includes various mindfulness techniques, such as focused breathing, body scanning, acceptance, recognizing thoughts as mental events, and increasing awareness of thoughts and bodily sensations. Intervention group: Group 2. Participants in this group receive an intervention that includes virtual reality videos. The intervention begins with mindfulness exercises followed by watching virtual reality movies through a headset. After removing the headset, the therapist provides additional training. This intervention is implemented over eight sessions, with each session lasting 90 minutes, conducted once per week. Control group: Participants in this group will complete the questionnaires at three time points: pre-test, post-test, and follow-up. The participants in the control group will be placed on a waiting list, and after the intervention of the experimental group, to adhere to ethical considerations, the intervention will also be provided to the control group. The subjects' score in the rumination response style questionnaire should be lower than 44. Timepoint: The rumination response style questionnaire will be administered in three stages, including a pre-test (prior to the implementation of the intervention), a post-test (immediately after the completion of the intervention), and a one-month follow-up (one month after the intervention completion). Method of measurement: The Rumination Response Style Questionnaire consists of 22 four-point Likert items that assess various reactions to negative mood, including two subscales of rumination responses and distracting responses. The subject's score in the cognitive emotion regulation questionnaire. Timepoint: The cognitive emotion regulation questionnaire will be administered in three stages, including a pre-test (prior to the implementation of the intervention), a post-test (immediately after the completion of the intervention), and a one-month follow-up (one month after the intervention completion). Method of measurement: The Cognitive Emotion Regulation Questionnaire is a multidimensional instrument commonly used to assess cognitive coping strategies employed following exposure to negative events or situations. The subject's score in the McGill Pain Questionnaire. Timepoint: The McGill pain questionnaire will be administered in three stages, including a pre-test (prior to the implementation of the intervention), a post-test (immediately after the completion of the intervention), and a one-month follow-up (one month after the intervention completion). Method of measurement: The McGill Pain Inventory is a widely used and comprehensive scale for measuring pain perception, utilizing a lexical analysis approach, that was first published in 1975. This questionnaire assesses pain perception across four dimensions, including emotional pain, sensory pain, pain evaluation, and various pains. Iranian academic center for education culture and research Approved 2023-03-11 Research Ethics Committees of Mashhad Academic Center for Education, Culture and Research Mashhad Academic Center for Education, Culture and Research- University Campus-Azadi Square-Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)