Clinical trial NCT04971655: The Effect of Music Therapy on Pain and Anxiety
Official title: The Effect of Music Therapy on Anxiety and Pain in Individuals With Type 2 Diabetes Who Just Started Insulin Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
insulin
pain
anxiety
music therapy
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two groups with a music therapy group and control group
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Visual Pain Scale (VAS)
timeFrame: one hours
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: one hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: SATI CAN
state: Merkez
Study officials:
affiliation: Bolu Abant Izzet Baysal University, Health Sciences Faculty, Department of Nursing
name: Saadet CAN ÇİÇEK, Ph.D
role: STUDY_DIRECTOR
References: