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IRCT20251114067997N1 IRCT 2025-12-07 Ahvaz University of Medical Sciences The effect of mindfulness counseling on the quality of life of adolescent girls” “The effect of mindfulness counseling on the health-related quality of life in adolescent girls” 2026-01-04 anticipated 106 Complete https://irct.ir/trial/87825 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization method used in this study is cluster randomization, where the unit of randomization is at the school level rather than the individual level. In this approach, two schools with similar characteristics are selected from the same district, and the roles of the intervention group (mindfulness counseling) and the control group are randomly assigned to these two schools to prevent contamination between groups. The random sequence will be generated using conventional methods such as a random number table. Due to the nature of the intervention, complete allocation concealment is not feasible; both the students and the facilitator are aware of the group assignments, but to maintain study validity, the statistical analyst will remain blinded. N/A Health-Related Quality of Life. Intervention 1: Intervention group: In this group, the “Mindfulness Counseling Program” is delivered in 8 weekly group sessions, each lasting 45 minutes. The content of the sessions includes training in mindfulness principles, mindful breathing, body scan, managing thoughts and emotions, mindful communication skills, and final consolidation. Participants complete the KIDSCREEN‑52 questionnaire at three time points: baseline, post‑intervention, and follow‑up. Intervention 2: Control group: In this group, no intervention is provided. Participants only complete the KIDSCREEN‑52 questionnaire at three time points: baseline, post‑intervention, and follow‑up. After the study is completed, an educational brochure on mindfulness will be offered to the participants. Yes - There is a plan to make this available What will be shared: This dataset includes raw outcome-related variables (KIDSCREEN‑52 scores and demographic variables), fully de‑identified and coded to remove any personal identifiers.” When: “Data will be available beginning 6 months after publication and will remain accessible for 3 years.” To whom: Qualified researchers who submit a written request along with a valid research proposal and obtain approval from the Ethics Committee and the study team will be granted access Conditions: Data may be used solely for research purposes and for secondary analyses related to adolescent health. Access requires a written request, submission of a valid research proposal, absence of conflicts of interest, and approval from the Ethics Committee and the study team. Use is permitted for non-commercial purposes only. Where to obtain: Requests should be directed to Dr. Nahid Javadifar (Principal Investigator). Email: javadifar-n@ajums.ac.ir Affiliation: School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences How to obtain: The requester must first submit a formal written request along with a research proposal via email. The study team performs an initial review. If deemed appropriate, the request is forwarded to the university Ethics Committee for final approval. After ethics approval and signing a Data Use Agreement, the de‑identified, coded dataset or document will be provided to the researcher Comments:
public Zeinab Sayahi
Ahvaz, Jalali Alley, Between Helali and Ghaznavi, No. 269
Ahvaz Iran (Islamic Republic of) 6144915167 +98 938 085 0517 zynb72049@gmail.com Ahvaz University of Medical Sciences scientific Zeinab Sayahi
Ahvaz, Jalali Alley, between Helali and Ghaznavi, No. 269
Ahvaz Iran (Islamic Republic of) 6144915167 +98 61 3314 0000 zynb72049@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Voluntary participation with informed consent from the adolescent and parents. Female students aged 15–18 years enrolled in high schools. Studying in girls’ high schools in Ahvaz city. Availability during the intervention period (not during exam or vacation time). 15 years 18 years Female Occurrence of a severe stressful event within the past six months, such as the death of a parent or close relative. Presence of diagnosed physical or psychological disorders, based on medical history or clinical evaluation. Use of cigarettes or any addictive substances by the participant. Lack of willingness to participate or continue in mindfulness counseling sessions. Inability to attend the intervention sessions regularly due to illness or family issues F43.2 Adjustment disorders Lifestyle Lifestyle Intervention group: In this group, the “Mindfulness Counseling Program” is delivered in 8 weekly group sessions, each lasting 45 minutes. The content of the sessions includes training in mindfulness principles, mindful breathing, body scan, managing thoughts and emotions, mindful communication skills, and final consolidation. Participants complete the KIDSCREEN‑52 questionnaire at three time points: baseline, post‑intervention, and follow‑up. Control group: In this group, no intervention is provided. Participants only complete the KIDSCREEN‑52 questionnaire at three time points: baseline, post‑intervention, and follow‑up. After the study is completed, an educational brochure on mindfulness will be offered to the participants. The primary outcome variable in this study is Health-Related Quality of Life (HRQoL), which is measured to assess the effect of the 8-session Mindfulness Counseling intervention. Operationally, this variable is defined by the total scores obtained by participants across ten distinct domains of the kidscreen_52 questionnaire. These ten domains, which function as the specific primary outcome measures, include: Physical Health, Psychological Health, Feelings and Mood, Self-Perception, Autonomy, Parental Relationships and Family Life, Social Support and Peers, School Environment, Social Acceptance, and Financial Resources. The intervention’s effect will be determined by comparing the scores across these domains at the pre-test, post-test, and one-month follow-up assessment points. Timepoint: The time points for measuring the primary outcome (HRQoL) are precisely:Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: The standardized Kidscreen-52 Health-Related Quality of Life Questionnaire. The physical health of adolescent girls. Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire. Psychological Well‑Being. Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire.item 1-5. Moods and Emotions. Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire.item 12-18. Self‑Perception. Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire.item19-23. Autonomy. Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire.item24-28. Parent Relations and Home Life. Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire.item29-34. Social Support and Peers. Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire.item35-40. School Environment. Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire.item41-46. Social Acceptance (Bullying). Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire.item47-49. Financial Resources. Timepoint: Before the intervention (Baseline), immediately after the completion of the intervention, and one month after the completion of the intervention. Method of measurement: the standardized Kidscreen-52 health-related quality of life questionnaire.item50-52. Ahvaz University of Medical Sciences Approved 2025-09-27 Ethics Committee of Ahvaz University of Medical Sciences Ahvaz, Jalali Alley, between Helali and Ghaznavi, No. 269 Ahvaz Khouzestan Iran (Islamic Republic of)