The Effect of Music Therapy on Pain and Anxiety

NCT04971655 | Unknown

• 1 other identifier: AIBU-SBF-SC-01
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes; insulin; pain; anxiety; music therapy

Outcome Measures

Primary Outcomes (2)

• 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

• State-Trait Anxiety Inventory (STAI)

  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.

  one hours

Study Arms (2)

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.

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.

Interventions

Music therapy 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.

Music therapy group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

SATI CAN

Bolu, Merkez, 14100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance; Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Saadet CAN ÇİÇEK, Ph.D

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

  STUDY DIRECTOR

Central Study Contacts

SATI CAN, MSc

CONTACT

+90 532 490 62 81; can_s@ibu.edu.tr

Saadet CAN ÇİÇEK, Ph.D

CONTACT

+90 506 284 69 36; saadet.cancicek@ibu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: two groups with a music therapy group and control group

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 21, 2021
• Study Start: August 4, 2021
• Primary Completion: June 28, 2022
• Study Completion: July 15, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

TU (1)