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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorTarsus University

About this 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, 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

Declining to participate in or withdrawing from the study;

Having chronic pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mandala Coloring

    Other intervention

    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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Mandala coloring groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months

Secondary outcomes

1

Patient Satisfaction

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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