NCT07109492

Brief Summary

Surgical interventions often cause significant anxiety and stress in patients during the preoperative period. In this study, it is aimed to determine the effect of mandala coloring, a non-pharmacological and art-based intervention, on reducing anxiety and stress levels in individuals scheduled for elective surgery. The universe of the study will consist of patients who will undergo elective surgery between June 2025 and June 2026 in the General Surgery Clinic of Istanbul Sultangazi Training and Research Hospital. Data will be collected using the Introductory Information Form, State Anxiety Inventory (STAI-S), Perceived Stress Scale (PSS), and Physiological Parameters Form (including blood pressure, pulse, respiration rate, and oxygen saturation). One day before surgery, patients who meet the inclusion criteria will be informed about the study and randomized into intervention and control groups using a random number table created with MS Excel software. Patients in the intervention group will perform a 20-minute mandala coloring activity in the preoperative waiting period. Before and after the application, participants' anxiety and stress levels will be evaluated with the STAI-S and PSS, and their physiological parameters will be recorded. Patients in the control group will receive standard preoperative care and will be evaluated at the same time points with the same tools, without any intervention. The study aims to provide evidence for the use of mandala coloring as a simple, low-cost, and effective nursing intervention to reduce preoperative anxiety and stress.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress60%
Jul 2025Dec 2026

Study Start

First participant enrolled

July 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

July 31, 2025

Last Update Submit

November 23, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Effect of Mandala Painting on Anxiety

    State Anxiety Inventory: In this study, the "State Anxiety Inventory (STAI-I)" will be used before and after the mandala coloring to assess patients' situational anxiety. The inventory evaluates how individuals feel at a particular moment. It includes 20 items, each scored from 1 (Not at all) to 4 (Completely), reflecting the intensity of the emotion experienced. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse scored. Total scores range from 20 to 80; higher scores indicate greater anxiety. Additionally, the "Trait Anxiety Inventory (STAI-II)" measures general anxiety independent of specific situations, using a similar 20-item structure with frequency-based responses. The full inventory contains 40 items. High scores on either scale indicate higher anxiety levels. This validated tool enables objective pre- and post-intervention comparison of anxiety states in clinical settings.

    12 month

  • The Effect of Mandala Painting on Stress

    Perceived Stress Scale (PSS) This scale measures the extent to which a person subjectively perceives certain situations as stressful.The scale is a 5-point Likert format (0 = never; 4 = always) and consists of 4 questions for the positive dimension and 6 questions for the negative dimension. Scores obtained from the scale range from 0 to 40, with scores between 27 and 40 indicating perceived high levels of stress, scores between 14 and 26 indicating perceived moderate levels of stress, and scores between 0 and 13 indicating perceived low levels of stress. Translated with DeepL.com (free version) The patient will answer PSS questions before and after the mandala coloring.

    12 month

Study Arms (2)

Mandala painting

EXPERIMENTAL

Pre-surgery (Before Mandala Painting) Pre-surgery (After Mandala Painting - 20 minutes later)

Other: Mandala

Standard care

NO INTERVENTION

Since standard care will be applied to the patients in this group, in order to be parallel with the mandala group, the relevant scale questions will be answered by interviewing the patient 20 minutes before and after going to the operating room.

Interventions

MandalaOTHER

Mandala Painting

Mandala painting

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who are undergoing elective surgery,
  • Cholecystectomy Surgery is planned
  • Age 18 and over,
  • Able to communicate,
  • No wounds or injuries on their hands that would prevent them from painting,
  • Volunteer to participate in the study.

You may not qualify if:

  • Individuals with a previous psychiatric diagnosis,
  • Those with color blindness or visual perception disorders, Patients over 70 years of age
  • Those taking tranquilizers (anxiolytics, antidepressants, etc.),
  • Those with any health problems that may prevent them from painting (fractures, amputations, etc.),
  • Those who are illiterate,
  • Those with communication disabilities will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niran Çoban

Yalova, 77000, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • Mavridou P, Dimitriou V, Manataki A, Arnaoutoglou E, Papadopoulos G. Patient's anxiety and fear of anesthesia: effect of gender, age, education, and previous experience of anesthesia. A survey of 400 patients. J Anesth. 2013 Feb;27(1):104-8. doi: 10.1007/s00540-012-1460-0. Epub 2012 Aug 3.

    PMID: 22864564BACKGROUND
  • Mitchell M. General anaesthesia and day-case patient anxiety. J Adv Nurs. 2010 May;66(5):1059-71. doi: 10.1111/j.1365-2648.2010.05266.x. Epub 2010 Mar 9.

    PMID: 20337788BACKGROUND
  • Curry, N. A., & Kasser, T. (2005). Can coloring mandalas reduce anxiety? Art Therapy, 22(2), 81-85. https://doi.org/10.1080/07421656.2005.10129441

    BACKGROUND
  • Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Risk factors for postoperative anxiety in adults. Anaesthesia. 2001 Aug;56(8):720-8. doi: 10.1046/j.1365-2044.2001.01842.x.

    PMID: 11493233BACKGROUND
  • Baran, T., & Demirtaş, A. (2022). Mandala boyama etkinliğinin stresle baş etme ve dikkat düzeyine etkisi. Psikoloji Çalışmaları Dergisi, 42(2), 77-91

    BACKGROUND
  • Spielberger, C. D., Gorsuch, R. L., & Lushene, R. E. (1970). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.

    BACKGROUND

Study Officials

  • NİRAN ÇOBAN

    University of Yalova

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations