- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Şahinbey
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Gaziantep, Şahinbey, Türkei (türkiye), 27470
- Gaziantep Şehir Hastanesi
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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.
|
|
Sonstiges: 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.
Finger pressure was applied perpendicularly at a tolerable intensity to reduce procedural pain.
|
|
Sonstiges: 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.
|
|
Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pain Intensity During AVF Cannulation (VAS Score)
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Pain Scores Over Time
Zeitfenster: 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
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
- 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
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Pathologische Zustände, Anatomisch
- Angeborene Anomalien
- Herz-Kreislauf-Anomalien
- Gefäßmissbildungen
- Fistel
- Arteriovenöse Fehlbildungen
- Gefäßfistel
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Schmerz, prozedural
- Arteriovenöse Fistel
- Verwaltung des Gesundheitswesens
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Therapeutika
- Qualität der Gesundheitsversorgung
- Komplementäre Therapien
- Physiotherapiemodalitäten
- Qualitätsindikatoren, Gesundheitsversorgung
- Patientenversorgung
- Psychotherapie
- Verhaltensdisziplinen und Aktivitäten
- Rehabilitation
- Nachbehandlung
- Kontinuität der Patientenversorgung
- Therapie, Weichgewebe
- Muskuloskelettmanipulationen
- Sensorische Kunsttherapien
- Sorgfalt
- Akupressur
- Musiktherapie
Andere Studien-ID-Nummern
- GAÜN-SBF-PHD-001
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