The Effect of Music Therapy on Pain and Anxiety

NCT ID: NCT04971655

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2022-07-15

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Music therapy group

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.

Group Type: EXPERIMENTAL

Music therapy

Intervention Type: OTHER

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music therapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Satı Can

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saadet CAN ÇİÇEK, Ph.D

Role: STUDY_DIRECTOR

Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing

Locations

SATI CAN

Bolu, Merkez, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

SATI CAN, MSc

Role: CONTACT

can_s@ibu.edu.tr

+90 532 490 62 81

Saadet CAN ÇİÇEK, Ph.D

Role: CONTACT

saadet.cancicek@ibu.edu.tr

+90 506 284 69 36

Facility Contacts

SATI CAN, MSc

Role: primary

can_s@ibu.edu.tr

05324906281

Saadet CAN ÇİÇEK, Ph.D

Role: backup

saadet.cancicek@ibu.edu.tr

05062846936

Other Identifiers

AIBU-SBF-SC-01

Identifier Type: -

Identifier Source: org_study_id