The Effect of Music Therapy on Pain and Anxiety

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effect of Music Therapy on Anxiety and Pain in Individuals With Type 2 Diabetes Who Just Started Insulin Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04971655
• Other study ID #: AIBU-SBF-SC-01
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: March 2022
• Source: Abant Izzet Baysal University
• Contact: SATI CAN, MSc
• Phone: +90 532 490 62 81
• Email: can_s[@]ibu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: July 15, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	SATI CAN	Bolu	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one hours
Primary	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.	one hours