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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Dilek Kaloglu Binici, PhD
- Numer telefonu: +90 505 811 00 22
- E-mail: dkaloglu@artvin.edu.tr
Lokalizacje studiów
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Artvin
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Artvin, Artvin, Turcja (Türkiye), 08000
- Artvin State Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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. |
|
Brak interwencji: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in State Anxiety (STAI-S) Score Before Gynecological Examination
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Fear Levels Measured by Visual Analog Scale (VAS)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: At baseline and immediately after the 10-20-minute mandala coloring session or control waiting period, before gynecological examination.
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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.
|
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Pain Experienced During Gynecological Examination
Ramy czasowe: Immediately after gynecological examination.
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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.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Dilek Kaloglu Binici, PhD, Artvin Coruh University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ACU-MANDALA-GYN-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data will not be shared with other researchers. No IPD sharing is planned.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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