- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Gamze Bozkul
- Número de telefone: +903246000033
- E-mail: gamze.bozkul@gmail.com
Estude backup de contato
- Nome: GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
Locais de estudo
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Mersin, Turquia (Türkiye), 33400
- Tarsus University
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Contato:
- GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Control group
Participants in the control group will receive the hospital's routine preoperative care and standard clinical procedures.
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative Pain
Prazo: 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
Prazo: 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,
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient Satisfaction
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Gamze Bozkul, Tarsus University
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TU-BOZKUL-019
Plano para dados de participantes individuais (IPD)
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