Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate

NCT07723794 | Not Yet Recruiting

• 1 other identifier: TU-BOZKUL-019
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of mandala coloring on anxiety, pain, vital signs, and patient satisfaction in patients undergoing transurethral resection of the prostate (TURP). The sample size was calculated based on the effect size (Cohen's d = 0.48) reported, who examined the effect of mindfulness-based mandala coloring on anxiety levels in patients undergoing coronary angiography. The effect size was derived from the anxiety scores measured 30 minutes after the patients returned to the ward following angiography. sample size was increased to 64 participants, including 32 patients in the intervention group and 32 patients in the control group. Data will be collected using the Descriptive Characteristics Form, State Anxiety Inventory (SAI), Vital Signs Monitoring Form, Visual Analog Scale (VAS), and Patient Satisfaction Assessment Scale. The study procedure will be conducted as follows: Upon admission to the urology clinic for surgery, all participants will complete the Descriptive Characteristics Form, State Anxiety Inventory, and Vital Signs Monitoring Form before the surgical procedure.Patients admitted for TURP will be screened for eligibility by the research team. After obtaining written informed consent from eligible participants, the research team will notify an independent consultant, who will perform the random allocation and inform the principal investigator (GB) of each participant's group assignment.Participants assigned to the intervention group will be asked to select a mandala design from a coloring book and color it for 20 minutes.Participants in the control group will receive the hospital's routine preoperative care and standard clinical procedures.Following the intervention, all patients will be prepared for surgery and transferred to the operating room.After surgery, once the patients return to the ward and are settled in their beds, the State Anxiety Inventory, Vital Signs Monitoring Form, Visual Analog Scale, and Patient Satisfaction Assessment Scale will be administered.

Conditions

Mandala Coloring

Keywords

anxiety; pain; vital sign; Patient Satisfaction

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain

  This scale allows patients to evaluate their level of pain on a line ranging from 0 (no pain) to 10 (extremely severe pain). It will be used to assess the intensity of pain experienced by the patients.

  12 months

• Anxiety

  The scale is designed to assess an individual's current emotional state by asking respondents to answer the items according to how they feel at that moment. It consists of 20 items rated on a four-point Likert scale with response options ranging from 1 (Not at all) to 4 (Very much so). The scale is considered invalid if more than three items are left unanswered. Total scores range from 20 to 80, with higher scores indicating greater levels of state anxiety.

  12 months

• Vital Signs,

  The Vital Signs Monitoring Form is used to record patients' vital signs before the mandala coloring intervention (upon admission to their hospital room) and after they return to the ward following surgery.

  12 months

Secondary Outcomes (1)

• Patient Satisfaction

  12 months

Study Arms (2)

Mandala coloring group

EXPERIMENTAL

Participants assigned to the intervention group will be asked to select a mandala design of their choice from a mandala coloring book and color it for 20 minutes.

Other: Mandala Coloring

Control group

NO INTERVENTION

Participants in the control group will receive the hospital's routine preoperative care and standard clinical procedures.

Interventions

Mandala Coloring OTHER

Participants assigned to the intervention group will be asked to select a mandala design of their choice from a mandala coloring book and color it for 20 minutes.

Mandala coloring group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transurethral resection of the prostate (TURP) is a surgical procedure performed in male patients to treat benign prostatic enlargement by removing obstructive prostate tissue through the urethra using a resectoscope.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older;
• Scheduled to undergo transurethral resection of the prostate (TURP);
• Conscious, oriented, and able to communicate and cooperate;
• Provided written informed consent to participate in the study;
• Able to speak and understand Turkish;
• Without any disability that would interfere with participation;
• Without a diagnosed anxiety disorder.

You may not qualify if:

• Declining to participate in or withdrawing from the study;
• Having chronic pain.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (4)

• Zhang MQ, Liu X, Huang Y. Does Mandala Art Improve Psychological Well-Being in Patients? A Systematic Review. J Integr Complement Med. 2024 Jan;30(1):25-36. doi: 10.1089/jicm.2022.0780. Epub 2023 Sep 1.

  PMID: 37668598 BACKGROUND

• Akay G, Koc ES, Oguzhan H. Mandala coloring reduces anxiety and pain in circumcised children: A randomized controlled trial. J Pediatr Nurs. 2025 Sep-Oct;84:243-250. doi: 10.1016/j.pedn.2025.06.029. Epub 2025 Jun 19.

  PMID: 40541002 BACKGROUND

• Ghorbani Z, Farahani AS, Khabazkhoob M, Hosseini A, Rassouli M. Evaluating the effectiveness of mandala coloring on post-operative anxiety in mothers of children undergoing congenital anomaly surgery: A randomized controlled clinical trial. J Pediatr Nurs. 2025 May-Jun;82:e175-e183. doi: 10.1016/j.pedn.2025.04.010. Epub 2025 Apr 18.

  PMID: 40253270 BACKGROUND

• Akyol S, Yildirim AD. The effect of mandala activity on postoperative pain, anxiety, and analgesia use in gynecologic oncology patients: a randomized controlled trial. Cancer Causes Control. 2026 Feb 2;37(3):37. doi: 10.1007/s10552-026-02125-4.

  PMID: 41627562 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gamze Bozkul

  Tarsus University

  STUDY DIRECTOR

Central Study Contacts

Gamze Bozkul

CONTACT

+903246000033; gamze.bozkul@gmail.com

GAMZE BOZKUL

CONTACT

gamze.bozkul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be allocated to the study groups using a simple randomization method based on a random number table by an independent researcher who is not involved in the study. The randomization sequence will be generated using the Randomizer website (https://www.randomizer.org/). Patients admitted to the urology clinic for TURP will be screened for eligibility by the research team (GB and colleagues). After confirming eligibility and obtaining written informed consent, the research team will notify the independent researcher, who will assign participants to the intervention or control group and communicate the allocation only to the principal investigator (GB). This allocation process is intended to ensure that the researchers involved in patient recruitment, participants, their relatives, and clinical staff remain blinded to group assignment. To minimize bias during statistical analysis, all participant data will be coded as K1, K2, or K3 without revealing group allocation before
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study was planned as a randomized controlled experimental study

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)