]>
IRCT20151107024919N23 IRCT 2026-10-10 Kerman University of Medical Sciences The Effect of Mindfulness on Body Shame and Self-Stigma in patients with type 1 Diabetes referred to the Healthcare Centers of Kerman University of Medical Sciences The Effect of Mindfulness on Body Shame and Self-Stigma in patients with type 1 Diabetes referred to the Healthcare Centers of Kerman University of Medical Sciences 2026-10-23 anticipated 80 Recruiting https://irct.ir/trial/93514 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the researcher will visit the healthcare centers of Kerman University of Medical Sciences to recruit eligible individuals. Eligible patients will be selected via convenience sampling. To allocate participants to the control and intervention groups, stratified randomization based on gender will be employed. Participants will first be stratified by gender (male and female), and then within each stratum, they will be randomly assigned to either the control or intervention group using a simple randomization method with a 1:1 allocation ratio. The randomization sequence will be generated using Open Epi software. To ensure allocation concealment, the randomization list will be held by an individual independent of the research team. Allocation for each participant will be assigned by contacting this person, ensuring that the researcher remains blinded to the group assignment until the patient is officially enrolled in the study, Blinding description: Due to the educational nature of the intervention, blinding of participants and the researcher is not feasible. However, since the scoring is self-reported by the patients, the potential for researcher bias in the results is minimized. Furthermore, to control for bias during the data analysis phase, the data will be analyzed by an independent statistician who is blinded to group assignments. Data for both the intervention and control groups will be entered into SPSS and labeled as ‘Group 1’ and ‘Group 2.’ The analyst will remain unaware of which group corresponds to the intervention and which to the control throughout the analysis process. N/A Condition 1: type 1 Diabetes. Condition 2: Psychological factors associated with Type 1 diabetes. Intervention 1: Intervention group: The intervention is based on a modified version of the Mindfulness-Based Stress Reduction (MBSR) program originally developed by Kabat-Zinn. It consists of eight weekly group sessions, each lasting approximately 90 to 120 minutes. The sessions incorporate various mindfulness practices, including sitting meditation, body scan, walking meditation, and mindful movement, alongside discussions on concepts related to present-moment awareness and mindful responding to stress. The researcher has completed the MBSR training under the supervision of the thesis advisor, who will verify the competence and adequacy of the instruction. Homework and exercises will be assigned at the end of each session for practice between meetings. Additionally, educational videos and supplementary explanations will be provided asynchronously via the ‘Eitaa’ messenger, which will also serve as a platform for participants to ask questions, receive answers, and resolve issues. The researcher will monitor the completion of practice assignments and provide necessary feedback. Each session will commence with a review of participants’ experiences with the previous week’s exercises, offering sufficient opportunity for Q&A, troubleshooting, feedback, and discussion regarding barriers to practice. Intervention 2: Control group: Participants in the control group will not receive any educational content. Interaction with this group will be limited to necessary notifications regarding questionnaire completion schedules and routine clinical follow-ups, including reminders for medical appointments and the opportunity to ask general questions related to diabetes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The researcher is ethically reluctant to share.
public Batool Tirgari
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences scientific Batool Tirgari
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Aged 16 to 20 Definitive diagnosis of Type 1 diabetes by an endocrinologist At least 6 months since the diagnosis of Type 1 diabetes Ability to read and write and participate in group intervention sessions Scoring above 17 on the Body Image Shame Scale Scoring above 21 on the Diabetes Self-Stigma Scale 16 years 20 years Both Diagnosis of severe psychiatric disorders such as psychosis, autism, developmental delay, or suicidal ideation Presence of comorbid physical or chronic conditions (excluding hypertension) that interfere with diabetes management, such as cystic fibrosis, or renal and liver diseases History of substance abuse E10 F54 Type 1 diabetes mellitus Psychological and behavioral factors associated with disorders or diseases classified elsewhere Other Other Intervention group: The intervention is based on a modified version of the Mindfulness-Based Stress Reduction (MBSR) program originally developed by Kabat-Zinn. It consists of eight weekly group sessions, each lasting approximately 90 to 120 minutes. The sessions incorporate various mindfulness practices, including sitting meditation, body scan, walking meditation, and mindful movement, alongside discussions on concepts related to present-moment awareness and mindful responding to stress. The researcher has completed the MBSR training under the supervision of the thesis advisor, who will verify the competence and adequacy of the instruction. Homework and exercises will be assigned at the end of each session for practice between meetings. Additionally, educational videos and supplementary explanations will be provided asynchronously via the ‘Eitaa’ messenger, which will also serve as a platform for participants to ask questions, receive answers, and resolve issues. The researcher will monitor the completion of practice assignments and provide necessary feedback. Each session will commence with a review of participants’ experiences with the previous week’s exercises, offering sufficient opportunity for Q&A, troubleshooting, feedback, and discussion regarding barriers to practice. Control group: Participants in the control group will not receive any educational content. Interaction with this group will be limited to necessary notifications regarding questionnaire completion schedules and routine clinical follow-ups, including reminders for medical appointments and the opportunity to ask general questions related to diabetes. Body Shameا. Timepoint: The effect of a mindfulness-based training program on body shame in patients with Type 1 diabetes is evaluated in two stages: pre-intervention and immediately post-intervention (at the end of week 8). Method of measurement: BISS: Body Image Shame Scale. Self-Stigma. Timepoint: The effect of a mindfulness-based training program on self-stigma in patients with Type 1 diabetes is evaluated in two stages: pre-intervention and immediately post-intervention (at the end of the 8th week). Method of measurement: DSSS: Diabetes Self-Stigma Scale. Kerman University of Medical Sciences Approved 2026-09-12 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)