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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Artvin Coruh University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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