Effect of Music During Toe Amputation
ConditionAmputation
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 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 criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
Patients under 18 years of age,
With hearing/speech impairment,
With a diagnosis of psychiatric disorders,
With any kind of professional training in music,
Trial design
Design model
Parallel
Treatments tested in this trial
Music listening
Other interventionSelection of Sufi music will be played to the patients during the course of the operation.
Treatment groups
120 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-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
3 days2
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
3 daysSecondary outcomes
1
Surgical Fear Questionnaire
Surgical Fear Questionnaire was developed by Theunissen et al. in 2014 to determine the level of fear of short- and long-term consequences of surgery in patients who will undergo elective surgery. The scale is an 11-point Likert scale with 8 items, each scored from 0 to 10, where 0 represents "I am not scared at all" and 10 represents "I am very scared." It is divided into two sub-dimensions, each containing four items, reflecting different sources of fear. Items 1-4 assess the fear of short-term consequences of surgery, while items 5-8 focus on the fear of long-term consequences.
Time frame
3 days2
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: 1. = Strongly disagree 2. = Disagree 3. = Undecided 4. = Agree 5. = 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
3 daysSponsors and contacts
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Source ClinicalTrials.gov
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