The Effect of Music Therapy on Comfort, Pain and Anxiety in Patients With Bone Marrow Aspiration and Biopsy: A Randomized Controlled Research
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone Marrow Disease
- Sponsor
- Izmir Bakircay University
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) Pain and Comfort
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Objectives: This study was conducted to determine the effect of music therapy on the pain, anxiety, and comfort levels of patients who underwent bone marrow aspiration and biopsy.
Methods: This research was conducted as a randomized controlled study in the hematology polyclinic of a university hospital. Music therapy will used with the intervention group throughout the procedure. During data evaluation, paired t-test, independent t-test and effect size will used. The sample group was calculated based on the sample groups of other studies in the literature (Çelebi et al., 2020; Özdemir et al., 2019). According to the preliminary power analysis results using the G.Power 3.1.9 program, the sample size was calculated at 80% power, at medium effect size at 5% alpha value. According to the analysis results, the sample size per group was calculated as 30. However, since there was 10% probability that some patients may drop, the sample size for the study was recalculated as 66 (Experimental Group: 33, Control Group: 33).The patients will informed about using music. In addition, it will explained that they could adjust the sound levels and that they should report when they are disturbed by the tone. Music continued throughout the process. Communication with the patient will maintained, and symptoms such as discomfort, anxiety were observed throughout the procedure. The music player will switched off after the procedure was completed. The patients will asked whether they had any discomfort while the music played. TThe music therapy will last an average of 30 minutes. After completing the procedures, the patient's pain, comfort, and anxiety levels were re-evaluated using VAS and STAI.
Investigators
seda şahan
Phd research assistant
Izmir Bakircay University
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of hematological malignancy (defined as multiple myeloma, Chronic Lymphocytic Leukaemia, Myelodysplastic syndrome or indolent lymphoma)
- •18 years of age or older,
- •Must be able to speak Turkish
Exclusion Criteria
- •Hearing impairment
- •hormonal dysfunction (adrenal, pituitary, thyroid, etc.)
- •Sever anxiety disorder
- •Parkinson's disease
- •Alzheimer's disease
- •Major depression
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) Pain and Comfort
Time Frame: 10 minutes
The scale, used to measure patients' subjective pain and comfort, was developed by Price et al. (1983) (Price et al., 1983). This scale consists of a 10 cm horizontal or vertical line with both ends representing the minimum and maximum scores for pain and comfort (0: no pain/no discomfort (very comfortable), 10: most severe pain/very uncomfortable (not at all). Comfort was defined by patients as a pleasant feeling and as the absence of physical discomfort. The patients will asked to indicate their pain severity and comfort on the scale. The distance between the indicated point and the lowest endpoint of the line will measured in centimeters using a ruler, and the numeric value will assigned as the individual's pain score.
Secondary Outcomes
- State Trait Anxiety Scale (STAI)(10 minutes)