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

November 5, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Artvin
      • Artvin, Artvin, Turkey (Türkiye), 08000
        • Artvin State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Mandala Coloring

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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in State Anxiety (STAI-S) Score Before Gynecological Examination
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.
At baseline and immediately after the 10-20-minute mandala coloring session or control waiting period, before gynecological examination.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fear Levels Measured by Visual Analog Scale (VAS)
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.
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)
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.
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
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.
At baseline and immediately after the 10-20-minute mandala coloring session or control waiting period, before gynecological examination.
Pain Experienced During Gynecological Examination
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.
Immediately after gynecological examination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artvin Coruh University

Investigators

  • Principal Investigator: Dilek Kaloglu Binici, PhD, Artvin Coruh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 5, 2026

First Submitted That Met QC Criteria

November 5, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACU-MANDALA-GYN-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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