An interventional study of Musictherapy in Bone Marrow Disease and Hematological Malignancy, sponsored by Izmir Bakircay University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Izmir Bakircay University · Not applicable, Interventional, and Supportive care
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.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 66 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
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Exclusion Criteria:
The patients were asked about the type of music they wanted to listen to. Especially in the last meta-analyses, it was determined that listening to the music that patients chose was more effective (Witten 2020). For this reason, after the intervention group is asked about the music they want to listen to, the music they want will be played from the music application.
Other: Musictherapy
The patients in the control group will not listen to music, and routine procedures will performed in the clinic without additional intervention. Anxiety, pain, and comfort assessments will made in the control group patients before and after the procedure.
The patients were asked about the type of music they wanted to listen to. Especially in the last meta-analyses, it was determined that listening to the music that patients chose was more effective (Witten 2020). For this reason, after the intervention group is asked about the music they want to listen to, the music they want will be played from the music application.
Visual Analog Scale (VAS) Pain and Comfort
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.
Time frame: 10 minutes
State Trait Anxiety Scale (STAI)
The inventory consisting 40 items was developed by Spielberger et al. (1983) (Spielberger, 1983). The STAI consists of two separate scales to assess state (STAI-S) and trait (STAI-T) anxiety. Öner (1998) performed the Turkish validity and reliability studies of the scale. In the validity and reliability study of the STAI Turkish form, test-retest reliability coefficients ranged from 0,94 to 0,96 for state anxiety and ranged from 0,83 and 0,87 for trait anxiety. The State Anxiety Inventory with 20 items (Items 1-20) that assess the respondent's current feelings was used in this study. Each item is rated on a 4-point Likert scale from 1 (Almost never) to 4 (Almost always). Subscale scores range from 20 to 80, and higher scores indicate higher anxiety levels
Time frame: 10 minutes
Plan to share: Undecided — Other researchers can get information by sending an e-mail to the responsible researcher of this study. (seda.sahan@bakircay.edu.tr)
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Izmir Bakircay University