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

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.

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.

Behavioral: Mandala Coloring

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.

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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