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- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Şahinbey
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Gaziantep, Şahinbey, Turquie (Türkiye), 27470
- Gaziantep Şehir Hastanesi
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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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Listening to instrumental Classical Turkish Music (Acemaşiran mode) via headphones starting 5 minutes before AVF cannulation and continuing throughout the procedure.
|
|
Autre: 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.
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Manual acupressure applied to the Hegu (LI4) point on the hand contralateral to the AVF site for approximately 3 minutes prior to AVF cannulation.
|
|
Autre: 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.
|
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.
|
|
Autre: Standard Care
Routine hemodialysis care without additional music or acupressure intervention during AVF cannulation.
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Routine hemodialysis care without additional music or acupressure intervention during AVF cannulation.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain Intensity During AVF Cannulation (VAS Score)
Délai: During each hemodialysis session over 3 consecutive sessions (March-November 2024)
|
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.
|
During each hemodialysis session over 3 consecutive sessions (March-November 2024)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Pain Scores Over Time
Délai: 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.
|
Baseline and across 3 consecutive hemodialysis sessions
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
- 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- La douleur
- Manifestations neurologiques
- Maladies vasculaires
- Maladies cardiovasculaires
- Conditions pathologiques, anatomiques
- Anomalies congénitales
- Anomalies cardiovasculaires
- Malformations vasculaires
- Fistule
- Malformations artério-veineuses
- Fistule vasculaire
- Maladies et anomalies congénitales, héréditaires et néonatales
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Douleur, Procédure
- Fistule artério-veineuse
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Thérapeutique
- Qualité des soins de santé
- Thérapies complémentaires
- Modalités de physiothérapie
- Indicateurs de qualité, soins de santé
- Soins aux patients
- Psychothérapie
- Disciplines et activités comportementales
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Thérapie, tissus mous
- Manipulations musculo-squelettiques
- Thérapies d'art sensorielles
- Standard de soins
- Acupression
- Musicothérapie
Autres numéros d'identification d'étude
- GAÜN-SBF-PHD-001
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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