Diabetes Mellitus, Type 2NCT04971655
The Effect of Music Therapy on Pain and Anxiety
A study testing Music therapy in people with Diabetes Mellitus, Type 2, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The effect of music therapy on pain and anxiety will be evaluated in individuals with diabetes who start insulin therapy for the first time. Music will be played during the training. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and over
- Able to speak and understand Turkish
- No hearing problem
- With place and time orientation
- Does not have any psychiatric disease
- Insulin therapy for the first time
- Volunteers will be included in the study
Who cannot join
- Under 18 years old
- Does not speak Turkish
- Hearing problems
- No place and time orientation
- Having any psychiatric disease
- Non-volunteer individuals will not be included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SATI CAN
Bolu, Merkez, 14100
SATI CAN, MSc, 05324906281, can_s@ibu.edu.tr
Saadet CAN ÇİÇEK, Ph.D, 05062846936, saadet.cancicek@ibu.edu.tr
About this study
Official title: The Effect of Music Therapy on Anxiety and Pain in Individuals With Type 2 Diabetes Who Just Started Insulin Therapy
The effect of music therapy on pain and anxiety will be evaluated in individuals with diabetes who start insulin therapy for the first time. Music will be played during the training.
Read the detailed description
The prevalence of diabetes is increasing all over the world. Prevention of diabetes complications by providing glycemic control is the most important goal of diabetes treatment. Timely initiation of insulin therapy may be advantageous in ensuring glycemic control. Insulin therapy should be started without delay, especially in patients with Type 2 diabetes, in cases such as other diseases that intervene and increase the need for insulin, severe insulin resistance, surgery, pregnancy or progression of diabetes complications. However, most people with diabetes are reluctant to start insulin therapy, which may delay the start of treatment. In particular, he is reluctant to start insulin therapy for reasons such as the thought that insulin will limit his life, the concern that insulin is harmful, the expectation of pain due to injection, the worry that he will not be able to make insulin successfully, the fear of hypoglycemia, and that he will have to use insulin constantly. This situation can cause negative diabetes outcomes such as poor glycemic, diabetes complications, increased risk of death and disability. For this reason, sufficient time should be taken to address insulin-related concerns and persuaded to use insulin. In studies, music therapy is used as a supportive care intervention, as a noninvasive nursing intervention, music therapy is used to reduce pain and anxiety and increase compliance. Music, which is called the food of the soul, has been used by many civilizations in the treatment of physiological and psychological problems since ancient times. The use of music for therapeutic purposes since ancient civilizations has led to the emergence of the concept of music therapy. Music therapy has shown serious developments in the historical process, especially at the end of the 20th century. Experimentally, music therapy has been used, and it has been observed that scientific studies have been carried out to improve the physical and psychological conditions of the patients, especially during and after the procedure. As a result of the studies, it has been shown that music has positive effects on human health, affects human activities and has positive cognitive effects. However, the effect of conditions such as the type of music and the preference of the patient is also in question in achieving this effect. For this reason, it is important to determine the type of music specific to the person and the disease in terms of positive effect.
When the literature is examined, it is seen that music therapy is used in different areas such as mental health, diabetic foot ulcer management, neuropathic pain, glucose control in individuals with diabetes and positive results are obtained. This study was planned as a randomized controlled study to determine the effect of insulin injection on reducing pain and anxiety in diabetic individuals who were started on insulin therapy for the first time.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Music therapy
- Keywords
- diabetes, insulin, pain, anxiety, music therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Music therapy will be applied throughout diabetes education. Turkish Folk, Classical, Turkish Art and Sufi Music genres will be offered to individuals as an option and will be listened to throughout the process. Instrumental works will be uploaded to the computer by the researchers and will be played on the loudspeaker during the training.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy group | Experimental | When individuals with diabetes apply to diabetes education after their polyclinic examination, music therapy will be applied in addition to routine monitoring and applications throughout the education. Turkish Folk, Classical, Turkish Art and Sufi Music genres will be offered as options to the individuals in the intervention group and will be listened to throughout the process. During the training, the selected music will be played over the loudspeaker. Before the training, this group; Patient Description Form and Spielberger State-Trait Anxiety Scale will be applied. After the training, Visual Analogue Scale and State Anxiety Scale will be applied. Receives: Other: Music therapy |
| Control group | No intervention | When individuals apply to diabetes education after their polyclinic examinations, routine monitoring and application will be made throughout the education. Before the training, this group; Patient Description Form and Spielberger State-Trait Anxiety Scale will be applied. After the training, Visual Analogue Scale and State Anxiety Scale will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Pain Scale (VAS)
The patient assigns a value between 0 and 10 for pain. On the scale, there is '0' no pain, '10' very severe pain levels. The patient marks his current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient gives the pain score. 1-4 points: mild pain, 5-6 points: moderate pain, 7 points and above: severe pain.
Measured: one hours
State-Trait Anxiety Inventory (STAI)
The scale consists of two parts:
- State Anxiety Scale: It is a 4-point Likert-type scale consisting of 20 questions aiming to measure how individuals feel themselves at the moment. The scores obtained from the scale range from 20 to 80, with high scores indicating high anxiety and low scores indicating low anxiety levels. 0-19 points from the scale indicate that there is no anxiety, 20-39 points indicate mild, 40-59 points moderate, 60-79 points indicate the level of severe anxiety, and a score above 60 indicates the need for professional help.
- Trait Anxiety Scale: It indicates how the person feels during the process, regardless of the situation and conditions. The scores obtained from the scale vary between 20 and 80, and a high score indicates a high level of anxiety, and a low score indicates a low level of anxiety. 0-30 indicates low anxiety, 31-49 indicates moderate anxiety, and 50 and higher indicates high anxiety.
Measured: one hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start4 Aug 2021
- Primary completion28 Jun 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- two groups with a music therapy group and control group
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satı Can, Abant Izzet Baysal University
- Investigators
- Saadet CAN ÇİÇEK, Ph.D, Study director, Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971655
- Sponsor's protocol ID
- AIBU-SBF-SC-01
- Status last verified
- Mar 2022
- First submitted
- 22 Jun 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Anxiety and Pain in Individuals With Type 2 Diabetes Who Just Started Insulin Therapy
- ClinicalTrials.gov ID
- NCT04971655
- Acronym / sponsor ID
- AIBU-SBF-SC-01
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, insulin, pain, anxiety, music therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 28 Jun 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 21 Jul 2021 (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.
The effect of music therapy on pain and anxiety will be evaluated in individuals with diabetes who start insulin therapy for the first time. Music will be played during the training.
Detailed description
The prevalence of diabetes is increasing all over the world. Prevention of diabetes complications by providing glycemic control is the most important goal of diabetes treatment. Timely initiation of insulin therapy may be advantageous in ensuring glycemic control. Insulin therapy should be started without delay, especially in patients with Type 2 diabetes, in cases such as other diseases that intervene and increase the need for insulin, severe insulin resistance, surgery, pregnancy or progression of diabetes complications. However, most people with diabetes are reluctant to start insulin therapy, which may delay the start of treatment. In particular, he is reluctant to start insulin therapy for reasons such as the thought that insulin will limit his life, the concern that insulin is harmful, the expectation of pain due to injection, the worry that he will not be able to make insulin successfully, the fear of hypoglycemia, and that he will have to use insulin constantly. This situation can cause negative diabetes outcomes such as poor glycemic, diabetes complications, increased risk of death and disability. For this reason, sufficient time should be taken to address insulin-related concerns and persuaded to use insulin. In studies, music therapy is used as a supportive care intervention, as a noninvasive nursing intervention, music therapy is used to reduce pain and anxiety and increase compliance. Music, which is called the food of the soul, has been used by many civilizations in the treatment of physiological and psychological problems since ancient times. The use of music for therapeutic purposes since ancient civilizations has led to the emergence of the concept of music therapy. Music therapy has shown serious developments in the historical process, especially at the end of the 20th century. Experimentally, music therapy has been used, and it has been observed that scientific studies have been carried out to improve the physical and psychological conditions of the patients, especially during and after the procedure. As a result of the studies, it has been shown that music has positive effects on human health, affects human activities and has positive cognitive effects. However, the effect of conditions such as the type of music and the preference of the patient is also in question in achieving this effect. For this reason, it is important to determine the type of music specific to the person and the disease in terms of positive effect.
When the literature is examined, it is seen that music therapy is used in different areas such as mental health, diabetic foot ulcer management, neuropathic pain, glucose control in individuals with diabetes and positive results are obtained. This study was planned as a randomized controlled study to determine the effect of insulin injection on reducing pain and anxiety in diabetic individuals who were started on insulin therapy for the first time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups with a music therapy group and control group
| Arm | Type | Receives |
|---|---|---|
| Music therapy group | Experimental | Other: Music therapyWhen individuals with diabetes apply to diabetes education after their polyclinic examination, music therapy will be applied in addition to routine monitoring and applications throughout the education. Turkish Folk, Classical, Turkish Art and Sufi Music genres will be offered as options to the individuals in the intervention group and will be listened to throughout the process. During the training, the selected music will be played over the loudspeaker. Before the training, this group; Patient Description Form and Spielberger State-Trait Anxiety Scale will be applied. After the training, Visual Analogue Scale and State Anxiety Scale will be applied. |
| Control group | No intervention | –When individuals apply to diabetes education after their polyclinic examinations, routine monitoring and application will be made throughout the education. Before the training, this group; Patient Description Form and Spielberger State-Trait Anxiety Scale will be applied. After the training, Visual Analogue Scale and State Anxiety Scale will be applied. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old and over
- Able to speak and understand Turkish
- No hearing problem
- With place and time orientation
- Does not have any psychiatric disease
Key exclusion criteria (6 listed)
- Under 18 years old
- Does not speak Turkish
- Hearing problems
- No place and time orientation
- Having any psychiatric disease
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 therapyMusic therapy will be applied throughout diabetes education. Turkish Folk, Classical, Turkish Art and Sufi Music genres will be offered to individuals as an option and will be listened to throughout the process. Instrumental works will be uploaded to the computer by the researchers and will be played on the loudspeaker during the training. | Other | Music therapy group |
Primary outcome
Visual Pain Scale (VAS)
Time frame: one hours
The patient assigns a value between 0 and 10 for pain. On the scale, there is '0' no pain, '10' very severe pain levels. The patient marks his current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient gives the pain score. 1-4 points: mild pain, 5-6 points: moderate pain, 7 points and above: severe pain.
State-Trait Anxiety Inventory (STAI)
Time frame: one hours
The scale consists of two parts: 1. State Anxiety Scale: It is a 4-point Likert-type scale consisting of 20 questions aiming to measure how individuals feel themselves at the moment. The scores obtained from the scale range from 20 to 80, with high scores indicating high anxiety and low scores indicating low anxiety levels. 0-19 points from the scale indicate that there is no anxiety, 20-39 points indicate mild, 40-59 points moderate, 60-79 points indicate the level of severe anxiety, and a score above 60 indicates the need for professional help. 2. Trait Anxiety Scale: It indicates how the person feels during the process, regardless of the situation and conditions. The scores obtained from the scale vary between 20 and 80, and a high score indicates a high level of anxiety, and a low score indicates a low level of anxiety. 0-30 indicates low anxiety, 31-49 indicates moderate anxiety, and 50 and higher indicates high anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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. This study is not recruiting at the moment.
Saadet CAN ÇİÇEK, Ph.D study director
Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing
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 therapy in people with Diabetes Mellitus, Type 2, run by Abant Izzet Baysal 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SATI CAN, MSc (+90 532 490 62 81, can_s@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Pain Scale (VAS) (time frame: one hours). 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 3 Mar 2022.