CanserNCT07789236
Mandala Coloring and Music for Cancer Fear and Screening Anxiety
A study testing mandala and Music in people with Canser and Fear Cancer, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Canser, Fear Cancer, Anxiety
- What is being tested?
- mandala and Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having a diagnosed psychiatric disorder.
- Having a hearing impairment severe enough to interfere with the music intervention.
- Having a history of diagnosed cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ağrı İbrahim Çeçen University
Ağrı, Ağri, 04100
About this study
Official 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
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.
Read more
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.
- Conditions
- Canser, Fear Cancer, Anxiety
- Being tested
- mandala, Music
- Keywords
- Cancer, Screening, Fear, Anxiety
- Medical subject headings
- Pathophobia, Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandalaOther
Participants will receive a 20-minute mandala coloring intervention before the screening procedure.
MusicOther
Participants will receive a 20-minute music intervention before the screening procedure.
| Study group | Role | What they receive |
|---|---|---|
| 1 mandala | Experimental | Participants will receive a 20-minute mandala intervention before the screening procedure. Receives: Other: mandala |
| 3 control | No intervention | control |
| 2 musıc | Experimental | Participants will receive a 20-minute music intervention before the screening procedure. Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (immediately before the intervention) and immediately after the 30-minute intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 May 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CanserStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURTEN ÖZÇALKAP, Agri Ibrahim Cecen University
- Investigators
- Nurten OZCALKAP, asisst. prof, Principal investigator, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789236
- Sponsor's protocol ID
- AICU-KETEM-157-2026
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oner N, Le Compte A. Durumluk-Sürekli kaygı envanteri elkitabı, 20. Basım İstanbul: Boğaziçi Üniversitesi Yayınları, 1985. s.3-5.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07789236
- Acronym / sponsor ID
- AICU-KETEM-157-2026
- Conditions
- Canser, Fear Cancer, Anxiety
- Keywords
- Cancer, Screening, Fear, Anxiety
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 mandala | Experimental | Other: mandalaParticipants will receive a 20-minute mandala intervention before the screening procedure. |
| 3 control | No intervention | –control |
| 2 musıc | Experimental | Other: MusicParticipants will receive a 20-minute music intervention before the screening procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Having a diagnosed psychiatric disorder.
- Having a hearing impairment severe enough to interfere with the music intervention.
- Having a history of diagnosed cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mandalaParticipants will receive a 20-minute mandala coloring intervention before the screening procedure. | Other | 1 mandala |
| MusicParticipants will receive a 20-minute music intervention before the screening procedure. | Other | 2 musıc |
Primary outcome
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.
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. 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- BackgroundOner N, Le Compte A. Durumluk-Sürekli kaygı envanteri elkitabı, 20. Basım İstanbul: Boğaziçi Üniversitesi Yayınları, 1985. s.3-5.
- Individual participant dataSharing planned: No
Related trials for Canser
RecruitingObservational study
The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
Ostomy - Ileostomy or Colostomy, Canser
RecruitingPhase 2
Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
Recurrent Vulvar Cancer, Persistent Vulvar Cancer
Not yet recruitingObservational study
Clinical Study of 68Ga-DOTA-BLP PET Imaging in Noninvasive Diagnosis of Malignant Tumors
Canser
Not yet recruiting
Benson Relaxation Exercises and Sleep Quality in Lung Cancer Patients
Sleep Quality, Relaxation
Enrolling by invitation
Breathing Exercise Application in Patients With Gynecological Cancer.
Gynecological Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nurten OZCALKAP, asisst. prof principal investigator
Agri Ibrahim Cecen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mandala and Music in people with Canser and Fear Cancer, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2. Fear of Cancer Scale (FOCS) (time frame: Baseline (immediately before the intervention) and immediately after the 30-minute intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07789236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.