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Enrolling by invitation

NCT Number: NCT07789236

Mandala Coloring and Music for Cancer Fear and Screening Anxiety

Cancer screening is important for detecting cancer at an early stage. However, women attending cancer screening may experience fear of cancer and anxiety related to the screening process. Simple, non-drug approaches that promote relaxation may help reduce these feelings and make the screening experience more comfortable.

The purpose of this randomized controlled study is to determine whether a combined mandala coloring and music intervention can reduce cancer fear and anxiety among women attending a Cancer Early Diagnosis, Screening and Training Center (KETEM) for cancer screening.

Women aged 30 to 65 years who attend the KETEM unit for their first or routine cancer screening, meet the study eligibility criteria, and agree to participate will be included in the study. Participants will be randomly assigned to one of two groups: an intervention group or a control group.

Participants in the intervention group will color a mandala for 20 minutes while listening to slow-tempo instrumental music. The intervention will take place in the KETEM waiting area. Participants in the control group will receive the standard information and routine services provided at KETEM without the mandala coloring and music intervention.

Cancer fear and anxiety will be assessed using questionnaires before and after the intervention. The researchers will compare the results between the intervention and control groups to determine whether the combined mandala coloring and music intervention helps reduce cancer fear and anxiety during the cancer screening process.

The findings of this study may provide information about whether a simple, low-cost, and non-drug intervention can be used to support women attending cancer screening and make the screening experience less stressful.

Enrolling by invitation

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Key information

Conditions

Canser Anxiety Anxiety Disorders Fear Cancer Mental Disorders Neoplasms Pathophobia

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ağrı İbrahim Çeçen University

Ağrı, Ağri, 04100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a woman aged 30-65 years.

*Applying for cancer screening for the first time or for routine screening.

  • Being able to read and write in Turkish.
  • Providing voluntary informed consent to participate in the study.

Exclusion criteria

  • Having a diagnosed psychiatric disorder.
  • Having a hearing impairment severe enough to interfere with the music intervention.
  • Having a history of diagnosed cancer.

Treatment and study plan

Mandala

Other

Participants will receive a 20-minute mandala coloring intervention before the screening procedure.

Music

Other

**Participants will receive a 20-minute music intervention before the screening procedure.**

Primary outcomes

  1. 2. Fear of Cancer Scale (FOCS)

    Time frame: Baseline (immediately before the intervention) and immediately after the 30-minute intervention

    The Fear of Cancer Scale (FOCS) was developed by Feng and colleagues and the validity and reliability study of the Turkish version was conducted by Öztürk and Kuday. The scale consists of 17 items and two subscales: Direct Fear (items 1, 2, 4, 8, 9, 10, 12, and 13) and Indirect Fear (items 3, 5, 6, 7, 11, 14, 15, 16, and 17).

    Each item is rated on a 5-point Likert scale ranging from 0 to 4 (0 = Strongly Disagree, 1 = Disagree, 2 = Neither Agree nor Disagree, 3 = Agree, and 4 = Strongly Agree). The total score ranges from 0 to 68, with higher scores indicating greater fear of cancer.

    The overall Cronbach's alpha coefficient of the scale was reported as 0.920. The Cronbach's alpha coefficients were 0.870 for the Direct Fear subscale and 0.861 for the Indirect Fear subscale.

  2. 1. Personal Information Form

    Time frame: Baseline

    The Personal Information Form was developed by the researchers based on the relevant literature and includes questions assessing the participants' sociodemographic characteristics.

  3. 3. State Anxiety Inventory (STAI-I)

    Time frame: Baseline (immediately before the intervention) and immediately after the 30-minute intervention

    According to Öner and Le Compte, anxiety can be conceptualized as two distinct forms: state anxiety and trait anxiety. This distinction was initially proposed through the factor-analytic studies of Cattell and Scheier and subsequently formed the basis of the two-factor theory of anxiety developed through the work of Spielberger and colleagues

    The State-Trait Anxiety Inventory is a self-report instrument consisting of brief statements designed to assess anxiety. Although it was originally developed to assess anxiety among psychiatrically healthy adults, subsequent studies have demonstrated its applicability to high school students as well as individuals with psychiatric and physical health conditions.

Sponsors and collaborators

Lead sponsor

Agri Ibrahim Cecen University

Other

Registry information

Official study title

The Effect of Mandala Coloring and Music Interventions on Cancer Fear and Screening Anxiety Among Individuals Applying to Cancer Early Diagnosis, Screening and Training Centers (KETEM): A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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