Effect of Music During Wound Debridement
ConditionDebridement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAfyonkarahisar Health Sciences University
About this trial
This randomized controlled intervention study aims to investigate the effect of music played before the debridement on patients' anxiety, pain, and sense of safety.
The study will be carried out with two groups: The control and the intervention groups with 100 participants for each group. While the control group participants will receive standard care, the intervention group participants will listen to selection of Sufi music before the debridement in addition to standard care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or above,
Visiting the hospital due to diabetic foot,
Requiring wound debridement,
Having wound debridement at least once before,
Disqualifiers
Patients under 18 years of age,
Visiting the hospital for other wound causes,
Having debridement before and after toe amputation,
Having wound debridement for the first time
Trial design
Design model
Parallel
Treatments tested in this trial
Music Listening
Other interventionSelection of Sufi music will be played to the patients before the wound debridement.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention Group- Listening to Sufi MusicExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Numerical Rating Scale-Pain (NRS-P)
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.
Time frame
15 minutes before the procedure and 5 minutes after the procedure2
Numerical Rating Scale-Anxiety (NRS-A)
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.
Time frame
15 minutes before the procedure and 5 minutes after the procedureSecondary outcomes
1
Safety Feeling Scale
Safety Feeling Scale, developed by Dabaghi et al. in 2023, is designed to assess the sense of security among hospitalized adult patients. It includes four sub-dimensions: effective care (5 items), trust in the healthcare team (3 items), emotional enrichment (2 items), and hygienic facilities (2 items), totaling 12 items. The scale uses a five-point Likert scale for responses: * Strongly disagree * Disagree * Undecided * Agree * Strongly agree Raw scale scores range from 12 to 60, with higher scores indicating a stronger sense of safety experienced by the patient in the hospital.
Time frame
15 minutes before the procedure and 5 minutes after the procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: