Effects of Mandala Coloring Before Gynecological Examination on Anxiety, Fear, and Pain
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Dilek Kaloglu Binici, PhD
- Telefoonnummer: +90 505 811 00 22
- E-mail: dkaloglu@artvin.edu.tr
Studie Locaties
-
-
Artvin
-
Artvin, Artvin, Turkije (Türkiye), 08000
- Artvin State Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
|
Geen tussenkomst: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in State Anxiety (STAI-S) Score Before Gynecological Examination
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Fear Levels Measured by Visual Analog Scale (VAS)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Dilek Kaloglu Binici, PhD, Artvin Coruh University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ACU-MANDALA-GYN-2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Individual participant data will not be shared with other researchers. No IPD sharing is planned.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .