Music Effect on the Self-Injection, Testing Fear and Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-75
SponsorDicle University
About this trial
Diabetes is a chronic and broad-spectrum metabolic disorder characterized by hyperglycemia that occurs due to relative or absolute insulin deficiency or "insulin resistance" developed against insulin action in peripheral tissues, affecting many organs and causing multisystem involvement. Metabolic function continues to deteriorate after diagnosis, leading to worsening glycemic control and insulin therapy becoming necessary. However, patients may have difficulty adhering to insulin therapy. Fears about injections are common in both adults and children and, as research shows, are a major reason why people with diabetes avoid taking insulin. Addressing these fears is an important part of helping patients reduce their risk of diabetes-related complications. Helping patients manage their replacement pain may help reduce the effects of needle fear in the future. There are a number of strategies that can ease the pain.The use of music in pain management has advantages such as being reliable, cheap, and having no side effects, as well as reducing postoperative pain reports. Music distracts the individual from negative stimuli and allows them to focus on something they enjoy, thus reducing pain and anxiety. Music therapy has also been shown to have sedative-protective effects and reduce stress hormone levels. Listening to preferred music can distract and reduce the pain and negative emotions associated with an unpleasant experience.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Type 2 diabetes for at least one year
Self-administering insulin injection
Self-administering glucometer, insulin pen or insulin pump
Disqualifiers
poor mental health
Having gestational diabetes mellitus or Type 1 diabetes
no hearing problems
Trial design
Design model
Parallel
Treatments tested in this trial
Music Therapy
Other interventionMusic will be played during the insulin injection process
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Music groupExperimental treatment 1 intervention
Group B: Control group (Music free)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Visual Analogue Scale
The scale is used to assess subjectively perceived pain. It is a 10 cm (100 mm) ruler with no pain on one end and the "most severe pain" on the other. The individuals participating in the study are asked to mark the intensity of pain they are currently feeling, explaining that the number "0" on the scale means "I feel no pain" and that the intensity of pain increases as the numbers increase, and the number "10" means "I feel the most severe pain". An increase in the score obtained from the scale in the assessment indicates that the pain is increasing. Each patient will be administrated three times.
Time frame
Before insulin administration on day, Time Frame: After two insulin administration on the second daySecondary outcomes
1
Diabetes Fear of Self Injecting and Self-testing Questionnaire
Questionnaire measures fear of self-injection and testing in diabetic individuals who require insulin. Questionnaire, which contains 15 statements, consists of two sub-dimensions: fear of self-injecting (6 statements) and fear of self-testing (9 statements). Each statement has a four-point Likert-type scoring ranging from 0 to 3 (0= almost never, 1= sometimes, 2= often, 3= almost always). The evaluation of the questionnaire form can be done by taking the average or raw score for the two sub-dimensions and the entire form. When taken as raw score, self-injection fear score varies between 0-18, self-testing fear score between 0-27, and total fear score between 0-45. Increasing score indicates increasing fear. Each patient will be administrated three times.
Time frame
Before insulin administrated on day one, Time Frame: After two insulin administration on the second day.Sponsors and contacts
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Source ClinicalTrials.gov
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