NCT07789236

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 23, 2026

Last Update Submit

August 25, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 2. Fear of Cancer Scale (FOCS)

    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.

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

  • 1. Personal Information Form

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

    Baseline

  • 3. State Anxiety Inventory (STAI-I)

    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.

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

Study Arms (3)

1 mandala

EXPERIMENTAL

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

Other: mandala

3 control

NO INTERVENTION

control

2 musıc

EXPERIMENTAL

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

Other: Music

Interventions

mandalaOTHER

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

1 mandala
MusicOTHER

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

2 musıc

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ağrı İbrahim Çeçen University

Ağrı, Ağri, 04100, Turkey (Türkiye)

Location

Related Publications (1)

  • Oner N, Le Compte A. Durumluk-Sürekli kaygı envanteri elkitabı, 20. Basım İstanbul: Boğaziçi Üniversitesi Yayınları, 1985. s.3-5.

    BACKGROUND

MeSH Terms

Conditions

Pathophobia

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nurten OZCALKAP, asisst. prof

    Agri Ibrahim Cecen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asisst. prof.

Study Record Dates

First Submitted

August 23, 2026

First Posted

August 27, 2026

Study Start

May 1, 2026

Primary Completion

August 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations