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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The raw data for this study consists of information collected from participants after they completed the treatment process. This data is shareable after removing directly identifiable information (such as name and contact information). The final dataset will include the following variables:
Demographic information: age, gender, education level, marital status.
Primary outcome variables: pain intensity at different time points (pre-intervention, post-intervention, and follow-up).
Secondary outcome variables: scores on the Pain Acceptance Questionnaire (CPAQ), Pain Catastrophizing Questionnaire (PCS), Patient Health Questionnaire (PHQ for anxiety, depression, somatization), and Satisfaction with Life [SWLS Questionnaire] at the same time points.
Treatment group information: tDCS or iACT group allocation.
Relevant clinical information: duration of chronic pain, history of previous treatments.
The purpose of sharing these data is to enable peer review of the results by other researchers, replication of similar studies, and secondary analyses to discover new associations. The final decision to share all or parts of the data (such as only the primary outcome) will be made after further review, with full respect for ethical principles and individual privacy.
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When the data will become available and for how long
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The data from this study will be made available after the statistical analysis process is completed and the results of the study are formally published in a reputable scientific journal or presented at relevant congresses. The start date of data access will be six (6) months after the date of publication of the first scientific article based on the results of this clinical trial. The data access period will continue for five (5) years after the said start date. This period of time will allow researchers sufficient time to request access, review the data, and conduct secondary analyses.
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To whom data/document is available
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Data and documentation from this study will be made available only to qualified researchers, particularly those working in academic institutions, research centers, or scientific centers. Applicants must provide a clear research objective, a valid research design, and a commitment to ethical principles, confidentiality, and anonymity of participants. Access for non-academic/industrial individuals or institutions is also possible only if their request is scientifically and ethically justified and accompanied by the consent of the study director/principal investigator. Public and open access to raw participant data will not be provided.
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Under which criteria data/document could be used
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The data and documentation from this study may be used for non-commercial research and scientific purposes only. These purposes include:
Confirming and reviewing the results of the current study: Using the data to validate published findings and ensure their accuracy.
Conducting secondary analyses: Examining the data to discover new patterns, relationships, or findings that are not directly related to the original research questions but that contribute to scientific knowledge about chronic pain, the effectiveness of treatments, or related factors.
Development of new analytical methods: Use of data to test and validate new algorithms or statistical methods.
Education and learning: Use of data in educational settings (such as workshops or specialized courses) to train students and researchers in clinical data analysis.
Restrictions on use:
No commercial use: Any direct or indirect commercial use of the data, such as for the development of products or services, is prohibited.
No redistribution of raw data: Raw data (even after de-identification) should not be published in whole or in part in public data repositories or other publications without express permission from the research team.
Privacy: The researcher undertakes to make reasonable efforts to prevent re-identification of individuals, even if the data are presented in a non-identifiable form.
Attribution: In any report, article, or presentation using these data, the original source of the study (the IRCT clinical trial with the study ID) and the research team must be fully cited.
Submission of secondary analysis results: The results of secondary analyses that lead to significant scientific findings must be submitted to the study’s scientific team for initial review.
Requirements for submitting an access request:
Applicants must submit the following with their application:
1- Completed access request form: A form that includes full contact information, institutional affiliation, and details of the research proposal.
2- Submit a research proposal: A proposal that clearly describes the research objectives, research questions, intended methodology (including the type of statistical analyses), and how the data will be used. The proposal should demonstrate a direct connection to the study data.
3- Submit a scientific resume
4- Non-Disclosure and Ethical Use Agreement (NDA): Sign a non-disclosure agreement in which the applicant agrees to the terms of use, maintaining data confidentiality, not republishing raw data, and using it solely for research purposes.
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From where data/document is obtainable
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Visit the official website of the Iranian Clinical Trial Registration System (IRCT):
Website: www.irct.ir
In this system, you can find details about registered studies, including this study.
Contact the study data coordinator:
Name of the coordinator: Shahrzad Khoushghamat Aziz
Position: Study Project Manager
Email: shahrzad.kht20@yahoo.com or sh_khoushghamat@resident.mui.ac.ir
Telephone: 22000184_021 or 09129341123
Response hours: Saturday to Wednesday, 8 am to 4 pm
Important notes for applicants:
Initial referral: First follow up on your request via the IRCT website and then via email.
Also, when calling or sending an email, be sure to mention the relevant study ID (IRCT ID).
And provide your full information, institutional affiliation, and a brief summary of your research proposal so that your request can be properly referred.
Please note that reviewing requests and coordinating data sharing may take time. After submitting your request, be patient and follow up again by email or phone if you do not receive a response within a reasonable period of time (e.g., two business weeks).
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What processes are involved for a request to access data/document
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The approximate duration of this process varies depending on the complexity of the request and the workload of the review team, usually between 2 and 6 weeks.
Process of reviewing and granting access to data/documents:
Submission of initial request:
The applicant, by referring to the introduced resources (IRCT website, data coordinator email, or postal address), completes the access request form and submits it together with the research proposal, curriculum vitae (CV), and other required documents (such as research ethics approval if necessary).
Duration: Immediately after submission by the applicant.
Registration and initial review of the application:
The submitted documents are initially reviewed for completeness and compliance with the required formats. If any documents are incomplete, the applicant will be notified and given the opportunity to complete the documents. Duration: 1 to 3 working days.
Technical and scientific review of the proposal:
In this stage, the research objectives, methodology, direct connection of the research to existing data, and the suitability of the application with data sharing policies are evaluated. Duration: 1 to 2 working weeks.
Review of Non-Disclosure Agreement (NDA):
This agreement is required by the applicant. Duration: 1-2 business days
Final decision:
Duration: 1-3 business days.
Notification of result to the applicant:
The applicant will be informed of the result of the review (approval or rejection of the application) along with the necessary explanations (in case of rejection). Duration: 1-2 business days.
Preparation and submission of data/documentation:
If the application is approved, the desired data and documentation will be prepared. This step may include processes to de-identify the data.
Duration: 1-2 business weeks (depending on the volume and complexity of the preparation).
Completion of the process:
After receiving the data, the applicant must send an acknowledgement of receipt to the study team.
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Comments
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