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

July 19, 2026 updated by: Gamze BOZKUL, Tarsus University

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

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 by Kandemir et al. (2026), 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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 study is designed as a prospective, randomized controlled clinical trial. The study population will consist of patients scheduled to undergo TURP in the urology clinics of Tarsus State Hospital. The sample size was calculated based on the effect size (Cohen's d = 0.48) reported by Kandemir et al. (2026), 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. Power analysis performed with a significance level of α = 0.05 and a statistical power of 95% (1-β = 0.95) indicated that a total sample of 58 participants was required. Considering a potential attrition rate of 10%, the final 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 (GB and colleagues). 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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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
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.
No Intervention: Control group
Participants in the control group will receive the hospital's routine preoperative care and standard clinical procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 12 months
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
Time Frame: 12 months
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,
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 12 months
This scale allows patients to evaluate their level of Patient Satisfaction on a line ranging from 0 (no Patient Satisfaction) to 10 (extremely severe Patient Satisfaction). It will be used to assess the intensity of Patient Satisfaction experienced by the patients.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Investigators

  • Study Director: Gamze Bozkul, Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

July 19, 2026

First Submitted That Met QC Criteria

July 19, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 19, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU-BOZKUL-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mandala Coloring

Clinical Trials on Mandala Coloring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe