- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07723794
Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate
Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate: A Randomized Controlled Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Gamze Bozkul
- Numer telefonu: +903246000033
- E-mail: gamze.bozkul@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
Lokalizacje studiów
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Mersin, Turcja (Türkiye), 33400
- Tarsus University
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Kontakt:
- GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: Control group
Participants in the control group will receive the hospital's routine preoperative care and standard clinical procedures.
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Eksperymentalny: Mandala coloring 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Postoperative Pain
Ramy czasowe: 12 months
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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.
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12 months
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Anxiety
Ramy czasowe: 12 months
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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.
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12 months
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Vital Signs,
Ramy czasowe: 12 months
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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.
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12 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient Satisfaction
Ramy czasowe: 12 months
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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.
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12 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Gamze Bozkul, Tarsus University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- TU-BOZKUL-019
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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