跳至主要内容
临床试验/NCT07109492
NCT07109492招募中不适用

The Role of Mandala Painting Before Surgery on Anxiety and Stress

Niran Çoban1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
The Effect of Mandala Painting on Anxiety

研究概览

简要总结

Surgical interventions often cause significant anxiety and stress in patients during the preoperative period. In this study, it is aimed to determine the effect of mandala coloring, a non-pharmacological and art-based intervention, on reducing anxiety and stress levels in individuals scheduled for elective surgery. The universe of the study will consist of patients who will undergo elective surgery between June 2025 and June 2026 in the General Surgery Clinic of Istanbul Sultangazi Training and Research Hospital. Data will be collected using the Introductory Information Form, State Anxiety Inventory (STAI-S), Perceived Stress Scale (PSS), and Physiological Parameters Form (including blood pressure, pulse, respiration rate, and oxygen saturation). One day before surgery, patients who meet the inclusion criteria will be informed about the study and randomized into intervention and control groups using a random number table created with MS Excel software. Patients in the intervention group will perform a 20-minute mandala coloring activity in the preoperative waiting period. Before and after the application, participants' anxiety and stress levels will be evaluated with the STAI-S and PSS, and their physiological parameters will be recorded. Patients in the control group will receive standard preoperative care and will be evaluated at the same time points with the same tools, without any intervention. The study aims to provide evidence for the use of mandala coloring as a simple, low-cost, and effective nursing intervention to reduce preoperative anxiety and stress.

详细描述

Surgical procedures, although often lifesaving and necessary, are known to trigger significant levels of psychological distress, particularly in the preoperative period. This phase, characterized by uncertainty, fear of anesthesia, and concerns about postoperative outcomes, commonly leads to increased levels of anxiety and stress. Preoperative anxiety is reported in up to 85% of surgical patients and is associated with adverse outcomes such as elevated pain perception, delayed recovery, higher analgesic needs, increased cardiac complications, and lower patient satisfaction. While pharmacological approaches are commonly used, there is growing interest in non-pharmacological and holistic strategies to manage preoperative anxiety and stress effectively.

Among the emerging non-drug interventions, art-based therapeutic activities have gained attention due to their accessibility, affordability, and psychological benefits. One such method is mandala coloring, which involves filling in structured circular designs using colors of the participant's choice. The term "mandala" originates from Sanskrit, meaning "circle," and symbolizes wholeness and balance. According to Carl Jung, mandalas help individuals center themselves and connect with their inner states, offering a calming and integrative experience.

Mandala coloring has been shown to reduce stress and anxiety by directing attention to the present moment, promoting mindfulness, and eliciting meditative-like states. Unlike traditional art therapy, mandala coloring does not require artistic skill and can be easily implemented across various age and educational levels. Studies suggest that coloring mandalas decreases cortisol levels, improves emotional regulation, and enhances psychological well-being in different populations.

Despite its recognized benefits in mental health contexts, limited research exists on the use of mandala coloring specifically in surgical patients during the preoperative period. This study aims to fill this gap by evaluating the effect of a short, structured mandala coloring session on anxiety, stress, and selected physiological parameters among patients awaiting elective surgery.

The study will be conducted between June 2025 and June 2026 at Istanbul Sultangazi Training and Research Hospital's General Surgery Clinic. A total of 60 adult patients who meet the inclusion criteria will be recruited and randomly assigned to either the Mandala Coloring Group (intervention) or the Standard Care Group (control) using a random number table created in MS Excel.

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)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Individuals who are undergoing elective surgery,
  • •Cholecystectomy Surgery is planned
  • •Age 18 and over,
  • •Able to communicate,
  • •No wounds or injuries on their hands that would prevent them from painting,
  • •Volunteer to participate in the study.

排除标准

  • •Individuals with a previous psychiatric diagnosis,
  • •Those with color blindness or visual perception disorders, Patients over 70 years of age
  • •Those taking tranquilizers (anxiolytics, antidepressants, etc.),
  • •Those with any health problems that may prevent them from painting (fractures, amputations, etc.),
  • •Those who are illiterate,
  • •Those with communication disabilities will be excluded from the study.

研究组 & 干预措施

Mandala painting

Experimental

Pre-surgery (Before Mandala Painting) Pre-surgery (After Mandala Painting - 20 minutes later)

干预措施: Mandala (Other)

Standard care

No Intervention

Since standard care will be applied to the patients in this group, in order to be parallel with the mandala group, the relevant scale questions will be answered by interviewing the patient 20 minutes before and after going to the operating room.

结局指标

主要结局

The Effect of Mandala Painting on Anxiety

时间窗: 12 month

State Anxiety Inventory: In this study, the "State Anxiety Inventory (STAI-I)" will be used before and after the mandala coloring to assess patients' situational anxiety. The inventory evaluates how individuals feel at a particular moment. It includes 20 items, each scored from 1 (Not at all) to 4 (Completely), reflecting the intensity of the emotion experienced. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse scored. Total scores range from 20 to 80; higher scores indicate greater anxiety. Additionally, the "Trait Anxiety Inventory (STAI-II)" measures general anxiety independent of specific situations, using a similar 20-item structure with frequency-based responses. The full inventory contains 40 items. High scores on either scale indicate higher anxiety levels. This validated tool enables objective pre- and post-intervention comparison of anxiety states in clinical settings.

The Effect of Mandala Painting on Stress

时间窗: 12 month

Perceived Stress Scale (PSS) This scale measures the extent to which a person subjectively perceives certain situations as stressful.The scale is a 5-point Likert format (0 = never; 4 = always) and consists of 4 questions for the positive dimension and 6 questions for the negative dimension. Scores obtained from the scale range from 0 to 40, with scores between 27 and 40 indicating perceived high levels of stress, scores between 14 and 26 indicating perceived moderate levels of stress, and scores between 0 and 13 indicating perceived low levels of stress. Translated with DeepL.com (free version) The patient will answer PSS questions before and after the mandala coloring.

次要结局

未报告次要终点

研究者

发起方
Niran Çoban
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Niran Çoban

Asst.Prof.

University of Yalova

研究点 (1)

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