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- Ensaio Clínico NCT07657923
Music-Assisted Acupressure for Pain During AVF Cannulation in Hemodialysis Patients (MUSIC-ACUP)
Effect of Music-Assisted Acupressure on Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Trial
This randomized controlled trial was conducted to evaluate the effect of music-assisted acupressure on pain experienced during arteriovenous fistula (AVF) cannulation in hemodialysis patients. The study was carried out with 72 patients receiving hemodialysis treatment three times per week via AVF in a state hospital in Gaziantep, Türkiye.
Participants were randomly assigned to one of four groups: music-assisted acupressure, acupressure alone, music alone, and control group (routine care). The acupressure intervention was applied to the Hegu (LI4) point for approximately 3 minutes prior to needle insertion, while the music intervention consisted of listening to instrumental Classical Turkish Music in the Acemaşiran mode through headphones starting 5 minutes before cannulation and continuing until the end of the procedure.
Pain intensity during AVF cannulation was measured using the Visual Analog Scale (VAS) during three consecutive dialysis sessions. The primary outcome was pain severity during needle insertion. The study aimed to determine whether combining music therapy and acupressure would provide greater pain relief compared to single interventions or routine care.
Findings suggest that music-assisted acupressure may be an effective non-pharmacological nursing intervention for reducing procedural pain in hemodialysis patients.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This study was designed as a randomized controlled trial to investigate the effect of music-assisted acupressure on procedural pain during arteriovenous fistula (AVF) cannulation in patients undergoing hemodialysis. The study was conducted between March and November 2024 in the hemodialysis unit of a state hospital in Gaziantep, Türkiye.
A total of 72 eligible patients receiving hemodialysis treatment via AVF were included. Patients were randomly assigned into four equal groups (n=18 per group): music-assisted acupressure, acupressure, music, and control. Randomization was performed using a simple lottery method. All AVF cannulation procedures were performed by the same experienced dialysis nurse to ensure procedural consistency.
The acupressure intervention was applied to the Hegu (LI4) point on the hand contralateral to the AVF site. Finger pressure was applied perpendicularly for approximately 3 minutes prior to needle insertion. The music intervention consisted of listening to instrumental Classical Turkish Music in the Acemaşiran mode through headphones, beginning 5 minutes before cannulation and continuing until the end of the procedure.
Participants in the combined intervention group received both acupressure and music simultaneously using the same protocols described above. The control group received routine hemodialysis care without additional intervention.
Pain intensity during AVF cannulation was assessed using the Visual Analog Scale (VAS, 0-10) immediately after each procedure. Measurements were repeated over three consecutive hemodialysis sessions. Sociodemographic and clinical data were also collected using a structured patient information form.
The primary outcome of the study was pain intensity during AVF cannulation. Data were analyzed using non-parametric statistical tests due to non-normal distribution, including Kruskal-Wallis, Friedman, and Brunner-Langer models for repeated measures. Statistical significance was set at p < 0.05.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Şahinbey
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Gaziantep, Şahinbey, Turquia (Türkiye), 27470
- Gaziantep Şehir Hastanesi
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age ≥ 18 years
- Receiving hemodialysis treatment three times per week
- Presence of an arteriovenous fistula (AVF) for vascular access
- Ability to communicate in Turkish
- No use of analgesic medication prior to AVF cannulation
- No pain or pathology in the upper extremities that could affect intervention application or pain assessment
- Willingness to participate in the study and provide informed consent
Exclusion Criteria:
- Diagnosis of neuropathy
- History of upper extremity surgery or soft tissue injury
- Presence of bleeding disorders or coagulation disorders
- Diagnosis of heart failure
- Presence of a pacemaker
- Inability to comply with study procedures or complete data collection
- Any condition that could interfere with pain perception or the application of acupressure or music intervention
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Music-Assisted Acupressure Group
Listening to instrumental Classical Turkish Music (Acemaşiran mode) via headphones starting 5 minutes before AVF cannulation and continuing throughout the procedure.
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Combined application of acupressure at the Hegu (LI4) point for approximately 3 minutes together with simultaneous listening to instrumental Classical Turkish Music in the Acemaşiran mode starting 5 minutes before and continuing during AVF cannulation.
|
|
Outro: Acupressure
Manual acupressure applied to the Hegu (LI4) point on the hand contralateral to the AVF site for approximately 3 minutes prior to AVF cannulation.
|
Manual acupressure applied to the Hegu (LI4) point on the hand contralateral to the AVF site for approximately 3 minutes prior to AVF cannulation.
Finger pressure was applied perpendicularly at a tolerable intensity to reduce procedural pain.
|
|
Outro: Music Group
Participants listened to instrumental Classical Turkish Music in the Acemaşiran mode through headphones starting 5 minutes before AVF cannulation and continuing until the end of the procedure.
|
Listening to instrumental Classical Turkish Music in the Acemaşiran mode via headphones starting 5 minutes before arteriovenous fistula (AVF) cannulation and continuing until the end of the procedure.
The aim is to reduce procedural pain by distraction and emotional regulation.
|
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Outro: Standard Care
Routine hemodialysis care without additional music or acupressure intervention during AVF cannulation.
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Routine hemodialysis care without any additional intervention during arteriovenous fistula (AVF) cannulation.
Pain assessment was performed after the procedure using the Visual Analog Scale (VAS).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Intensity During AVF Cannulation (VAS Score)
Prazo: During each hemodialysis session over 3 consecutive sessions (March-November 2024)
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Pain intensity experienced during arteriovenous fistula (AVF) cannulation was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Measurements were obtained immediately after each cannulation procedure across three consecutive hemodialysis sessions.
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During each hemodialysis session over 3 consecutive sessions (March-November 2024)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Pain Scores Over Time
Prazo: Baseline and across 3 consecutive hemodialysis sessions
|
Changes in pain intensity across repeated AVF cannulation procedures were evaluated to assess the consistency and trend of intervention effects over time among study groups.
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Baseline and across 3 consecutive hemodialysis sessions
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
- Pain on arteriovenous fistula cannulation: A narrative review
- KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update
- Cannulation Technique of Vascular Access in Haemodialysis and the Impact on the Arteriovenous Fistula Survival: Protocol of Systematic Review
- How to needle: A mixed methods study on choice of cannulation technique for arteriovenous fistula
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Dor
- Manifestações Neurológicas
- Doenças Vasculares
- Doenças cardiovasculares
- Condições Patológicas, Anatômicas
- Anomalias congénitas
- Anormalidades cardiovasculares
- Malformações Vasculares
- Fístula
- Malformações Arteriovenosas
- Fístula Vascular
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor, Processual
- Fístula Arteriovenosa
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Terapêutica
- Qualidade de assistência médica
- Terapias complementares
- Modalidades de fisioterapia
- Indicadores de qualidade, assistência médica
- Atendimento ao paciente
- Psicoterapia
- Disciplinas e atividades comportamentais
- Reabilitação
- Cuidados posteriores
- Continuidade do atendimento ao paciente
- Terapia, tecido mole
- Manipulações músculo -esqueléticas
- Terapias de arte sensoriais
- Padrão de atendimento
- Acupressão
- Musicoterapia
Outros números de identificação do estudo
- GAÜN-SBF-PHD-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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