Ireland
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Effect of Music During Toe Amputation

NCT06776809 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-02-12
Last updated
2025-02-11

Condition(s) studied

Amputation

Investigational drug(s) / intervention(s)

Music listening

Music listening: Selection of Sufi music will be played to the patients during the course of the operation.

Study summary

This randomized controlled intervention study aims to investigate the impact of music played during toe amputation on patients' anxiety, pain, sense of safety, and fear of surgery.

The study will be carried out with two groups: The control and the intervention groups with 60 participants for each group. While the control group participants will receive standard care, the intervention group participants will listen to selection of Sufi music during the whole amputation procedure in addition to standard care.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years of age or above, * Having a toe amputation under spinal anesthesia due to diabetic foot, * Without hearing/speech impairment, * Without a diagnosis of psychiatric disorders, * Without any professional training in music, * and volunteered to participate. Exclusion Criteria: * Patients under 18 years of age, * With hearing/speech impairment, * With a diagnosis of psychiatric disorders, * With any kind of professional training in music, * and not willing to participate in the study.

Primary outcome measure(s)

  • Numerical Rating Scale-Anxiety (NRS-A) — 3 days
    The Numerical Rating Scale-Anxiety (NRS-A) has been widely used in research to assess anxiety levels, with its reliability and validity well-established. This scale, which ranges from 0 to 10, measures anxiety from "No Stress" (0) to "Very Bad Stress" (10). A higher score indicates a greater level of anxiety. The scale categorizes raw anxiety scores as follows: 0-no anxiety, 1-3-slightly anxious, 4-6-moderately anxious, 7-9-very or extremely anxious, and 10-the worst imaginable or extremely anxious.
  • Numerical Rating Scale-Pain (NRS-P) — 3 days
    The Numerical Rating Scale-Pain (NRS-P) is a one-dimensional tool that uses 11 numbers, ranging from 0 to 10, to assess pain intensity. The patient selects the number that most accurately reflects the severity of their pain, with 0 representing "no pain" and 10 indicating "the worst (unbearable) pain". The NRS-P is widely recognized as an effective method for measuring pain intensity, and it is generally considered more valid and reliable than other pain assessment scales.

Trial sites (1)

FacilityCityRegionStatus
Afyonkarahisar Health Sciences University Hospital, Afyonkarahisar Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06776809 on ClinicalTrials.gov ↗ ← All trials in Turkey