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Effects of Mandala Coloring Before Gynecological Examination on Anxiety, Fear, and Pain

2026年11月5日 更新者:Dilek Kaloglu Binici、Artvin Coruh University

Effect of Mandala Coloring Before Gynecological Examination on Anxiety, Fear, and Pain Perception: A Randomized Controlled Trial

Gynecological examinations are important for women's health, but they may cause anxiety, fear, discomfort, and pain. This study aims to evaluate whether mandala coloring before a gynecological examination can reduce anxiety, fear, and pain perception in women.

This randomized controlled trial will include 60 women aged 18-50 years attending the Gynecology and Obstetrics Outpatient Clinic at Artvin State Hospital in Türkiye. Participants will be randomly assigned to two groups. Women in the intervention group will complete a brief mandala coloring activity before their examination, while women in the control group will wait without receiving the intervention.

Anxiety, fear, and pain will be assessed using the State-Trait Anxiety Inventory and Visual Analog Scales at specified assessment points before and after the intervention or waiting period and following the gynecological examination.

The study will help determine whether mandala coloring can be used as a simple, low-cost, non-pharmacological supportive method to improve women's experiences during gynecological examinations.

研究概览

地位

尚未招聘

详细说明

Gynecological examinations are essential for the early detection, diagnosis, and management of women's reproductive health problems. However, these examinations may be associated with anxiety, fear, embarrassment, discomfort, and pain. Non-pharmacological interventions that promote relaxation and distraction may help reduce these negative experiences. Mandala coloring is a creative, attention-focused activity that may contribute to emotional regulation and relaxation.

**Study Design and Participants**

This study is designed as a two-arm, parallel-group randomized controlled trial to investigate the effects of mandala coloring before gynecological examination on anxiety, fear, and pain perception.

The study will be conducted at the Gynecology and Obstetrics Outpatient Clinic of Artvin State Hospital, Türkiye. A total of 60 women aged 18-50 years will be recruited. Eligible participants will be women who have previously undergone at least one gynecological examination, are scheduled for an outpatient gynecological examination without sedation or anesthesia, and provide written informed consent.

Participants will be randomly allocated using simple randomization to either the intervention group (n=30) or the control group (n=30).

**Intervention and Control Groups**

Women assigned to the intervention group will receive mandala coloring materials and colored pencils and will be asked to color a mandala pattern before the gynecological examination. This activity is intended to promote relaxation and redirect attention away from examination-related anxiety and fear.

Women assigned to the control group will undergo a corresponding waiting period without mandala coloring or any additional study intervention. Both groups will subsequently undergo the planned gynecological examination as part of routine clinical care.

**Data Collection and Assessments**

At baseline, participants will complete a sociodemographic information form, the State Anxiety Inventory (STAI-S), the Trait Anxiety Inventory (STAI-T), and Visual Analog Scales (VAS) assessing pain, fear, and anxiety.

After the mandala coloring activity or waiting period and before the gynecological examination, state anxiety, pain, fear, and anxiety will be reassessed using the STAI-S and the corresponding VAS measures.

Following the gynecological examination, participants will complete the VAS assessments for pain experienced during the examination, fear, and anxiety.

**Data Analysis**

Data will be analyzed using SPSS version 26.0. Descriptive statistics will be used to summarize participant characteristics and outcome scores. Between-group and within-group comparisons will be conducted using appropriate parametric or non-parametric tests according to data distribution. Changes in outcome measures will be compared between groups, and analysis of covariance (ANCOVA) will be performed when appropriate to adjust for baseline differences. Statistical significance will be set at p < 0.05.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Voluntary participation in the study and provision of written informed consent.
  • Being between 18 and 50 years of age.
  • Being scheduled for an outpatient gynecological examination without sedation or anesthesia.
  • Being able to read, understand, and complete the assessment instruments.
  • Having no cognitive, visual, or hearing impairment that prevents effective communication.
  • Having no known psychiatric diagnosis.
  • Not regularly using psychotropic medications that may affect anxiety levels.
  • Having undergone at least one previous gynecological examination.

Exclusion Criteria:

  • Incomplete, inaccurate, or unusable completion of data collection instruments.
  • Pregnancy or suspected pregnancy.
  • Development of acute complications during the gynecological examination or interruption of the procedure.
  • Presence of chronic gynecological conditions associated with severe pain, such as advanced pelvic inflammatory disease or endometriosis.
  • Diagnosis of malignancy or undergoing active oncological treatment.
  • Presence of cognitive, visual, or hearing impairments that prevent effective communication.
  • Withdrawal from the study at the participant's request.
  • Development of acute clinical changes that may affect the data collection process.
  • Use of psychotropic medications.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Mandala Coloring Group

Participants assigned to the intervention group (n=30) will perform a mandala coloring activity for 10-20 minutes before their scheduled gynecological examination. Following baseline assessments, participants will be provided with a mandala pattern and colored pencils. After the coloring activity, anxiety, fear, and pain perception will be reassessed before the examination. All participants will then undergo routine gynecological examination, followed by post-examination assessments.

Participants in the intervention group will be provided with a mandala pattern and colored pencils and asked to perform mandala coloring for 10-20 minutes before their scheduled gynecological examination. The activity is intended to promote relaxation and redirect attention away from examination-related anxiety and fear.

无干预:Control Group

Participants assigned to the control group (n=30) will undergo baseline assessments followed by a waiting period of 10-20 minutes without mandala coloring or any additional study intervention. Anxiety, fear, and pain perception will be reassessed before the gynecological examination. Participants will then undergo routine gynecological examination, followed by post-examination assessments.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in State Anxiety (STAI-S) Score Before Gynecological Examination
大体时间:At baseline and immediately after the 10-20-minute mandala coloring session or control waiting period, before gynecological examination.

State anxiety will be assessed using the 20-item State Anxiety Inventory (STAI-S). Total scores range from 20 to 80, with higher scores indicating greater anxiety. Change will be calculated as the post-intervention or post-waiting score minus the baseline score.

At baseline and immediately after the 10-20-minute mandala coloring session or control waiting period, before gynecological examination.

次要结果测量

结果测量
措施说明
大体时间
Change in Fear Levels Measured by Visual Analog Scale (VAS)
大体时间:At baseline, immediately after the 10-20-minute mandala coloring session or control waiting period (before examination), and immediately after gynecological examination.

Fear will be assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no fear) to 10 (extreme fear). Higher scores indicate greater fear. Changes in fear levels will be evaluated across three assessment points.

At baseline, immediately after the 10-20-minute mandala coloring session or control waiting period (before examination), and immediately after gynecological examination.
Change in Anxiety Levels Measured by Visual Analog Scale (VAS)
大体时间:At baseline, immediately after the 10-20-minute mandala coloring session or control waiting period (before examination), and immediately after gynecological examination.

Anxiety will be assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no anxiety) to 10 (extreme anxiety). Higher scores indicate greater anxiety. Changes in anxiety levels will be evaluated across three assessment points.

At baseline, immediately after the 10-20-minute mandala coloring session or control waiting period (before examination), and immediately after gynecological examination.
Change in Pain Levels Before Gynecological Examination
大体时间:At baseline and immediately after the 10-20-minute mandala coloring session or control waiting period, before gynecological examination.

Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Change will be calculated as the post-intervention or post-waiting score minus the baseline score.

At baseline and immediately after the 10-20-minute mandala coloring session or control waiting period, before gynecological examination.
Pain Experienced During Gynecological Examination
大体时间:Immediately after gynecological examination.

Immediately after the gynecological examination, participants will be asked to rate the pain they experienced during the examination using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

Immediately after gynecological examination.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dilek Kaloglu Binici, PhD、Artvin Coruh University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年11月5日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared with other researchers. No IPD sharing is planned.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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