AmputationNCT06776809
Effect of Music During Toe Amputation
A study testing Music listening in people with Amputation, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Music listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2025to 6 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Hospital,
Afyonkarahisar
About this study
Official title: Effect of Music Listened During Toe Amputation on Patients' Anxiety, Pain, Sense of Safety and Surgical Fear
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.
Read the detailed description
Diabetes rates are continuing to rise worldwide, leading to an increasing number of people with diabetes seeking medical care for foot wounds, with approximately 35% of diabetic individuals experiencing a foot wound at some point in their lives. Diabetic foot (DF) wounds tend to recur, with a 50% recurrence rate after treatment. Foot wounds are responsible for 85% of amputations in diabetics, and the five-year mortality rate following a lower extremity amputation rises to 77%. It is estimated that a diabetic patient undergoes an amputation every 20 seconds globally. Lower extremity amputations encompass a range of procedures, from hemipelvectomy to toe amputations. Among the most common partial amputations are those of the big toe and other toes, with diabetes being the cause of about 24% of these amputations.
A comprehensive meta-analysis examined the risk factors for amputation associated with diabetic foot ulcers and found that the overall incidence of lower extremity amputation in diabetic foot ulcer patients is 31%. This study provides crucial epidemiological data for medical practice. Key risk factors associated with lower extremity amputation include male gender, smoking history, body mass index (BMI), hypertension, cardiovascular disease, kidney disease, white blood cell count, hemoglobin, and albumin levels. Among these factors, BMI, hemoglobin, and albumin levels were negatively correlated with the likelihood of amputation, while other factors, such as gender, smoking, and comorbidities, showed positive correlations.
These findings highlight the importance of monitoring and addressing these risk factors in patients with diabetic foot ulcers to reduce the likelihood of lower extremity amputations. Consequently, targeted preventive and intervention measures focusing on these risk factors are essential in clinical practice to improve patient outcomes.
The literature reveals that pain following lower extremity amputation is widespread and remains a significant factor affecting patients' quality of life. If not properly managed, this post-amputation pain can have detrimental consequences for the patient. Effective pain control during the perioperative period has been shown to help prevent chronic stump pain, highlighting the importance of intraoperative anesthesia management and postoperative acute pain control. These factors influence the body's stress response to surgery and have a direct impact on recovery, discharge, and the return to daily activities. This is particularly critical for amputation patients, as early mobilization plays a key role in both physical and psychological recovery.
These findings underscore the importance of managing perioperative pain in patients undergoing lower extremity amputation, especially during the early postoperative period. Uncontrolled postoperative pain is one of the primary risk factors for the development of chronic pain following surgery. For amputee patients, pain, particularly in the early stages after surgery, is often accompanied by significant emotional challenges. Therefore, for comprehensive care, it is essential to consider the interplay between pain experience and the emotional well-being of patients who have not received adequate pain management.The literature reveals that pain following lower extremity amputation is widespread and remains a significant factor affecting patients' quality of life. If not properly managed, this post-amputation pain can have detrimental consequences for the patient. Effective pain control during the perioperative period has been shown to help prevent chronic stump pain, highlighting the importance of intraoperative anesthesia management and postoperative acute pain control. These factors influence the body's stress response to surgery and have a direct impact on recovery, discharge, and the return to daily activities. This is particularly critical for amputation patients, as early mobilization plays a key role in both physical and psychological recovery.
These findings underscore the importance of managing perioperative pain in patients undergoing lower extremity amputation, especially during the early postoperative period. Uncontrolled postoperative pain is one of the primary risk factors for the development of chronic pain following surgery. For amputee patients, pain, particularly in the early stages after surgery, is often accompanied by significant emotional challenges. Therefore, for comprehensive care, it is essential to consider the interplay between pain experience and the emotional well-being of patients who have not received adequate pain management.
Anxiety often begins when an individual is informed that they require surgery and tends to increase during hospitalization. This heightened anxiety can negatively impact the individual's quality of life, their ability to adapt to the illness, and the overall progression of the condition. Surgical patients, in general, are considered to be at higher risk for experiencing anxiety.
A sense of safety is an inherent human need, and it is crucial for patients to feel safe within healthcare environments. While all healthcare practices aim to ensure patient safety, it is equally important to assess whether these practices foster a sense of safety for the patient. The sense of safety experienced by patients plays a vital role in their overall health and well-being.
To date, no studies have explored the effects of music on pain, anxiety, and the sense of safety in patients before, during, or after any type of amputation. Therefore, our study aims to investigate the impact of music played during toe amputation on patients' anxiety, pain, sense of safety, and fear of surgery.
- Conditions
- Amputation
- Being tested
- Music listening
- Keywords
- Amputation, Toe amputation, Music, Pain, Anxiety, Surgical fear, Sense of Safety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningOther
Selection of Sufi music will be played to the patients during the course of the operation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in the control group will not be allowed to listen to music. These patients will receive standard health care in the Diabetic Foot and Wound Care Clinic. |
| Intervention Group- Listening to Sufi Music | Experimental | Patients in this group will listen to Sufi music during toe amputation in addition to standard health care in the Diabetic Foot and Wound Care Clinic. Music will be played to the patients with the help of Mp3 player and headphones throughout the operation. Disposable headphone covers will be used for the headphones and the covers will be changed for each patient. Receives: Other: Music listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
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.
Measured: 3 days
Secondary outcomes (2)
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.
Measured: 3 days
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start12 Feb 2025 (estimated)
- Primary completion6 Jan 2026 (estimated)
- Study completion6 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Ciğerci, Afyonkarahisar Health Sciences University
- Investigators
- Yeliz CIGERCI, Assoc.Prof., Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776809
- Sponsor's protocol ID
- 2024/11
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Listened During Toe Amputation on Patients' Anxiety, Pain, Sense of Safety and Surgical Fear
- ClinicalTrials.gov ID
- NCT06776809
- Acronym / sponsor ID
- 2024/11
- Conditions
- Amputation
- Keywords
- Amputation, Toe amputation, Music, Pain, Anxiety, Surgical fear, Sense of Safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 12 Feb 2025 (estimated)
- Primary completion
- 6 Jan 2026 (estimated)
- Study completion
- 6 Jan 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetes rates are continuing to rise worldwide, leading to an increasing number of people with diabetes seeking medical care for foot wounds, with approximately 35% of diabetic individuals experiencing a foot wound at some point in their lives. Diabetic foot (DF) wounds tend to recur, with a 50% recurrence rate after treatment. Foot wounds are responsible for 85% of amputations in diabetics, and the five-year mortality rate following a lower extremity amputation rises to 77%. It is estimated that a diabetic patient undergoes an amputation every 20 seconds globally. Lower extremity amputations encompass a range of procedures, from hemipelvectomy to toe amputations. Among the most common partial amputations are those of the big toe and other toes, with diabetes being the cause of about 24% of these amputations.
A comprehensive meta-analysis examined the risk factors for amputation associated with diabetic foot ulcers and found that the overall incidence of lower extremity amputation in diabetic foot ulcer patients is 31%. This study provides crucial epidemiological data for medical practice. Key risk factors associated with lower extremity amputation include male gender, smoking history, body mass index (BMI), hypertension, cardiovascular disease, kidney disease, white blood cell count, hemoglobin, and albumin levels. Among these factors, BMI, hemoglobin, and albumin levels were negatively correlated with the likelihood of amputation, while other factors, such as gender, smoking, and comorbidities, showed positive correlations.
These findings highlight the importance of monitoring and addressing these risk factors in patients with diabetic foot ulcers to reduce the likelihood of lower extremity amputations. Consequently, targeted preventive and intervention measures focusing on these risk factors are essential in clinical practice to improve patient outcomes.
The literature reveals that pain following lower extremity amputation is widespread and remains a significant factor affecting patients' quality of life. If not properly managed, this post-amputation pain can have detrimental consequences for the patient. Effective pain control during the perioperative period has been shown to help prevent chronic stump pain, highlighting the importance of intraoperative anesthesia management and postoperative acute pain control. These factors influence the body's stress response to surgery and have a direct impact on recovery, discharge, and the return to daily activities. This is particularly critical for amputation patients, as early mobilization plays a key role in both physical and psychological recovery.
These findings underscore the importance of managing perioperative pain in patients undergoing lower extremity amputation, especially during the early postoperative period. Uncontrolled postoperative pain is one of the primary risk factors for the development of chronic pain following surgery. For amputee patients, pain, particularly in the early stages after surgery, is often accompanied by significant emotional challenges. Therefore, for comprehensive care, it is essential to consider the interplay between pain experience and the emotional well-being of patients who have not received adequate pain management.The literature reveals that pain following lower extremity amputation is widespread and remains a significant factor affecting patients' quality of life. If not properly managed, this post-amputation pain can have detrimental consequences for the patient. Effective pain control during the perioperative period has been shown to help prevent chronic stump pain, highlighting the importance of intraoperative anesthesia management and postoperative acute pain control. These factors influence the body's stress response to surgery and have a direct impact on recovery, discharge, and the return to daily activities. This is particularly critical for amputation patients, as early mobilization plays a key role in both physical and psychological recovery.
These findings underscore the importance of managing perioperative pain in patients undergoing lower extremity amputation, especially during the early postoperative period. Uncontrolled postoperative pain is one of the primary risk factors for the development of chronic pain following surgery. For amputee patients, pain, particularly in the early stages after surgery, is often accompanied by significant emotional challenges. Therefore, for comprehensive care, it is essential to consider the interplay between pain experience and the emotional well-being of patients who have not received adequate pain management.
Anxiety often begins when an individual is informed that they require surgery and tends to increase during hospitalization. This heightened anxiety can negatively impact the individual's quality of life, their ability to adapt to the illness, and the overall progression of the condition. Surgical patients, in general, are considered to be at higher risk for experiencing anxiety.
A sense of safety is an inherent human need, and it is crucial for patients to feel safe within healthcare environments. While all healthcare practices aim to ensure patient safety, it is equally important to assess whether these practices foster a sense of safety for the patient. The sense of safety experienced by patients plays a vital role in their overall health and well-being.
To date, no studies have explored the effects of music on pain, anxiety, and the sense of safety in patients before, during, or after any type of amputation. Therefore, our study aims to investigate the impact of music played during toe amputation on patients' anxiety, pain, sense of safety, and fear of surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in the control group will not be allowed to listen to music. These patients will receive standard health care in the Diabetic Foot and Wound Care Clinic. |
| Intervention Group- Listening to Sufi Music | Experimental | Other: Music listeningPatients in this group will listen to Sufi music during toe amputation in addition to standard health care in the Diabetic Foot and Wound Care Clinic. Music will be played to the patients with the help of Mp3 player and headphones throughout the operation. Disposable headphone covers will be used for the headphones and the covers will be changed for each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music listeningSelection of Sufi music will be played to the patients during the course of the operation. | Other | Intervention Group- Listening to Sufi Music |
Primary outcome
Numerical Rating Scale-Anxiety (NRS-A)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Surgical Fear Questionnaire
Time frame: 3 days
Safety Feeling Scale
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yeliz CIGERCI, Assoc.Prof. principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with Amputation, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeliz CIGERCI, Assoc. Prof. (+902724440304, Yelizceylin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale-Anxiety (NRS-A) (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.