Mandala Coloring
Conditions
Keywords
anxiety, pain, vital sign, Patient Satisfaction
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.
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 , 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.
Interventions
OTHERMandala 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.
Sponsors
Tarsus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
The study was planned as a randomized controlled experimental study
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 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. |
| Anxiety | 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. |
| Vital Signs, | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTGamze Bozkul
CONTACTGAMZE BOZKUL
STUDY_DIRECTORGamze Bozkul
Tarsus University
Outcome results
None listed