Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07723794

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location contact

Gamze Bozkul

CONTACT

[email protected]

About this study

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 , 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

GAMZE BOZKUL

CONTACT

[email protected]

Gamze Bozkul

CONTACT

[email protected]

+903246000033

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.