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临床试验/NCT07551180
NCT07551180尚未招募不适用

Effect of a Mandala Activity on Anxiety Levels and Emotional and Psychological Well-Being in Adolescents Who Have Siblings With Special Needs: A Randomized Controlled Trial

Akdeniz University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
试验地点
1
主要终点
Anxiety Level

研究概览

简要总结

The purpose of this randomized controlled trial is to evaluate whether a structured mandala activity program can reduce anxiety and improve emotional and psychological well-being in adolescents who have a sibling with special needs. Adolescents in this group may experience emotional difficulties because of the demands and challenges associated with having a sibling who requires special care and support. However, supportive and accessible interventions for these adolescents are limited.

In this study, eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in a structured mandala activity program, while the control group will not receive this program during the study period. Anxiety and emotional and psychological well-being will be assessed before and after the intervention using standardized measurement tools.

The main question of this study is whether participation in the mandala activity program leads to better mental well-being outcomes compared with the control group. The findings may help determine whether mandala-based activities can be used as a simple, supportive, and non-pharmacological approach for adolescents who have a sibling with special needs.

详细描述

This randomized controlled trial is designed to investigate the effect of a structured mandala activity program on anxiety and emotional and psychological well-being in adolescents who have a sibling with special needs. Adolescents in this group may be affected by psychosocial challenges associated with living with and supporting a sibling who requires ongoing special care. These challenges may influence their emotional adjustment and psychological well-being. However, evidence-based supportive interventions specifically targeting this population remain limited.

The primary objective of the study is to evaluate whether participation in a structured mandala activity program reduces anxiety and improves emotional and psychological well-being in adolescents who have a sibling with special needs. The study also aims to generate evidence regarding the potential usefulness of a structured, supportive, and non-pharmacological intervention for this population.

Participants who meet the eligibility criteria will be randomly allocated to either the intervention group or the control group. The intervention group will participate in the mandala activity program delivered in a structured format. The control group will not receive the mandala intervention during the study period and will continue under usual conditions. Assessments will be conducted before and after the intervention using standardized measurement tools evaluating anxiety and emotional and psychological well-being.

This study is based on the assumption that structured mandala activities may provide emotional expression, psychological support, and a calming effect for adolescents who experience stress related to having a sibling with special needs. The results of the study are expected to contribute to the literature on adolescent mental health and to support the development of feasible and accessible psychosocial interventions for this potentially vulnerable group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants will be masked to group allocation and will not be informed whether they are assigned to the intervention group or the control group. Due to the nature of the study procedures, the researchers conducting the intervention and follow-up assessments will be aware of group assignment.

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents within the predefined study age range
  • Having a sibling with special needs
  • Ability to communicate in Turkish
  • Willingness to participate in the study
  • Written informed consent from a parent or legal guardian and assent from the adolescent
  • Availability to attend the planned intervention and assessment sessions

排除标准

  • Having any physical, cognitive, or communication problem that would prevent participation in the mandala activity program or completion of the measurement tools
  • Not attending the planned intervention sessions
  • Withdrawal of consent/assent during the study period

研究组 & 干预措施

Intervention Group

Experimental

Participants in this arm will receive a structured mandala activity program. The intervention is designed as a supportive behavioral program to reduce anxiety and improve emotional and psychological well-being. Assessments will be conducted before and after the intervention period.

干预措施: Mandala Activity Program (Behavioral)

Control Group

No Intervention

Participants in this arm will not receive the mandala activity program during the study period. They will continue under usual conditions and will complete the same assessments as the intervention group at the planned measurement times.

结局指标

主要结局

Anxiety Level

时间窗: Baseline and immediately after completion of the intervention

Change in anxiety level measured using the State-Trait Anxiety Inventory for Children.

次要结局

  • Emotional Well-Being(Baseline and immediately after completion of the intervention)
  • Psychological Well-Being(Baseline and immediately after completion of the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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