Design
This research was conducted as a mixed methods study in the hematology polyclinic of a university hospital during the period of March to May 2023. This was a mixed-method study that used a segregated design with sequential synthesis using a two-phase approach [16]. Quantitative data was collected in the first phase of the research and qualitative data was collected in the second phase. In the first stage, quantitative data were found about the effect of music on patients. In this section, it was found that music was effective on pain, anxiety, and comfort. Thus, it allowed to obtain the qualitative data necessary to examine this effect in depth. Integration of the results occurred in the discussion in which we scrutinized quantitative and qualitative findings in relation to each other [16]. Qualitative interview results were analyzed through reflexive thematic analysis (RTA) as described by Braun and Clarke [17].This study was registered at the ClinicalTrials.org (register number: NCT05895357 Date:08/06/2023).
Participants
The study was conducted with patients who were referred to the hematology clinic and who underwent BMAB for the first time. Inclusion criteria were as follows: to be 18 years of age or older, to undergo BMAB procedure, caring for an individual with hematological malignancy (defined as multiple myeloma, Chronic Lymphocytic Leukaemia, Myelodysplastic syndrome or indolent lymphoma)to have normal vital signs, to have adequate hearing, and to speak Turkish. Based on the exclusion criteria, those with hearing impairment and hormonal dysfunction (adrenal, pituitary, thyroid, etc.), those who were on anxiolytic and sedative drugs and who were diagnosed with severe anxiety disorder, Parkinson’s disease, Alzheimer’s disease, dementia, and major depression, were excluded from the study.
The sample group was calculated based on the effect size of other studies in the literature [11, 15]. 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). One patient in the experimental group did not fill in the post-intervention questionnaire saying that he did not have time, so the experimental group was completed with 32 patients. One patient in the control group did not want to answer the questions, the control group was completed with 32 patients as well (Fig. 1). Post hoc power analysis resulted in the following findings for the 32 control and 32 intervention groups: power (1-β) was 1.00 with α = 0.05 and effect size = 2.02 (according to t-test in independent groups for pain, anxiety and comfort scores).
Randomization
The https://www.randomizer.org website was used to generate a random list of all patients who satisfied the inclusion criteria. On the website http://www.randomizer.org/, a statistician who was impartial and blind to the sample’s identity randomly assigned it to the intervention and control groups. Random selection was used to assign the participants; evens were assigned to the experimental group and odds to the control group. Due to the nature of the study, neither the researchers nor the patients could be blinded. However, this study was single-blind, as statistical analyses were performed by an independent researcher. After randomization, the patients in the intervention and control groups were homogeneous (Table 1).
Data collection tools
Patient identification form
The form prepared by the researchers included patients’ age, gender and marital status [15, 18,19,20].
Visual analog scale (VAS)
Price et al. (1983) created the scale that is used to assess patients’ subjective levels of comfort and discomfort [21]. The pain and comfort thresholds on this scale are represented by the ends of a 10 cm horizontal or vertical line (0: no pain/no discomfort (extremely comfortable), 10: most severe pain/very uncomfortable (not at all). Patients described comfort as a pleasant emotion and the lack of physical pain. The patients were asked to rate their level of comfort and pain intensity on a scale. The individual’s pain score was determined by measuring the distance in millimeters between the stated location and the line’s lowest endpoint with a ruler.
State trait anxiety scale (STAI)
Spielberger et al. (1983) created the 40-item inventory [22]. The STAI consists of two separate scales to assess state (STAI-S) and trait (STAI-T) anxiety. Turkish research on the scale’s reliability and validity was carried out by Öner (1998) [23]. The STAI is made up of two distinct measures to measure both trait and state anxiety. This study made use of the State Anxiety Inventory, which contains 20 items (Items 1–20) that evaluate the respondent’s current emotions. The Likert scale ranges from 1 (Almost never) to 4 (Almost usually), with 4 being the highest rating. Scores on the subscale range from 20 to 80, with higher numbers indicating greater feelings of anxiety.
Study protocol
One of the researchers contacted the patients who would undergo the BMAB procedure. Patients were informed about the purpose of the study and the procedure. Written and verbal consent was obtained from the patients who consented to participate in the study. Patients were then randomly assigned to the experimental and control groups. Patients in the experimental and control groups were instructed to fill out questionnaires about anxiety, comfort and pain before the BMAB procedure. There was no change in the standard treatment of the intervention and control groups during the study period. The data collection forms were filled before and after the procedure by the experimental and control group participants in a face-to-face meeting with the researchers.
Intervention
Verbal and written consent forms were obtained from the patients who agreed to participate in the study. The patients were informed about the purpose of the study. Before the procedures, the patient’s pain, comfort, and anxiety levels were evaluated using VAS and STAI.
Because the response to music is generally individualized and dependent on the person’s prior experience and culture, allowing the participants to choose their favorite music is encouraged [24,25,26]. Kühlmann et al. (2018) and Chi and Young (2011) found that music chosen by the participants from a preselected list demonstrated positive outcomes [24, 25]. As a result, listening to patient-preferred music has been shown to be beneficial for reducing anxiety and pain [27, 28]. For this reason, in consultation with the music therapist, it was preferred that the patients listen to music of their own choice in this study. Before starting the procedure, the patients were asked to choose the non-verbal (without lyrics) music they wanted to listen to. The music selected by the patients was evaluated in terms of rhythm. A systematic review on music therapy revealed that music with a tempo between 60 and 90 bpm and non-verbal music was more effective in relaxation and stress reduction [27].
After appropriate music was selected, the patients were admitted to the procedure room. The music was played through a speaker (JBL Flip). Patients were informed about the buttons to turn the music on-off and adjust the volume. Patients were informed that they could turn off the music if they felt uncomfortable during the procedure or if they wanted to stop. At the same time, they were also informed that they could lower or raise the volume of the music, as the volume of the music could vary according to their hearing. Patients were asked to report any discomfort they felt during the music recital. However, there was no patient in the intervention group who did not want to listen to the music or stopped listening to the music. Patients kept listening to the same music throughout the BMAB procedure.
After the procedure was finished, the music player was turned off. The patients were asked if they felt any discomfort while the music played. The patients reported no discomfort or concerns concerning the use of music. Music application lasted an average of 30 min. After completing the procedures, the patient’s pain, comfort, and anxiety levels were re-evaluated using VAS and STAI. Data were collected simultaneously.
The patients in the control group did not listen to music, and standard clinic procedures were completed without any further involvement. Before and after the procedure, participants in the control group were assessed for anxiety, pain, and comfort.
Qualitative interview
Individual interviews were conducted one-on-one with the patients after the music application was finalized. Qualitative interviews were conducted by another researcher who did not perform the music to avoid bias. Qualitative interviews were conducted with 18 patients who agreed to participate in the interview. The interviews were conducted in an empty, quiet room in the clinic after the music intervention.
In the interview form utilized for the qualitative interview, open-ended questions were addressed to determine the patients’ attitudes toward music and the effect of music on the patients. In this way, questions that could not be answered or clarified as a result of the primary data (quantitative part) are provided with secondary data (qualitative interview) [29]. In this study, both the primary and secondary data processes fundamentally have the same structure and are based on the effect of music. At the same time, with qualitative interviews, it is aimed to find answers to questions that cannot be reached in quantitative interviews. With qualitative interviews, participants express their feelings and thoughts freely [30].
In the qualitative interview, patients were asked, ‘’What were the positive and negative effects of music for you?‘’ ‘’What emotions did you experience during music ?‘’, ‘’What did music mean to you?‘’ ‘’Would you like to use music in other procedures?‘’, ‘’What were your opinions about music application before the intervention and how/were your opinions changed currently?‘’. During the questions, guidance such as “What did you mean?” and “Can you explain a little more?” was provided so that the patients could elaborate more. The qualitative interview with the patients lasted an average of 60 min.
Data analysis
Quantitative data analysis
The SPSS (Statistical Package for Social Science) 21.0 package program was used to analyze the research data. The Shapiro-Wilk normality test was used to determine the normality distribution of the data. Descriptive statistics were given as the mean ± standard deviation and the median minimum value and maximum value. In the categorical variable comparisons, the chi-squared exact test was used, whereas the Mann-Whitney U test was used for the independent two-group comparisons and the Wilcoxon test for the dependent within-group comparisons. Furthermore, the effect size was employed to detail the comparative results. Cohen d was used to compute effect sizes. The effect size was classified as small (d = 0.20), medium (d = 0.50), and large (d = 0.80)(Cohen, 2013). Correlation analysis was employed for post-test comparisons of patients’ pain, comfort and anxiety. Consultancy was received from a biostatistician for the quantitative data of the study.
Qualitative data analysis
Audio recordings were recorded during the qualitative interviews with the patients. At the same time, the researcher took notes on a piece of paper for any questions that needed attention or guidance. The audio recordings of the interviews were transcribed by a researcher. The qualitative data of the study were analyzed using the 6 steps established by Braun and Clark [17].
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Step: Two researchers repeatedly read the transcribed audio recordings. The written text was transferred to MAXQDA 20.0.
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Step: At this stage, similarities and differences in the statements of the patients were recorded according to the first impression. Then, coding was carried out for each relevant text Sect.
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Step: The codes created in the 2nd stage were re-evaluated by the researcher and divided into more precise and descriptive codes. At this stage, the codes were inputted into the MAXQDA system separately.
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Step: Potentially interesting text passages coded in the previous stage were re-read by the authors. The text was discussed until the authors agreed on a common decision. The authors then developed preliminary themes. The codes were compared with other codes within the same cluster to determine whether the ongoing ranking was appropriate considering the purpose and data of the study. In this way, it was evaluated for which preliminary themes the codes were more appropriate.
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Step: Small changes were implemented in the ordering of the coded data among the themes. At this stage, the researchers prepared small summary texts about the content of these themes. In this way, it was revealed which codes did not belong to that theme, which ones yielded better results in another theme, and reordering was performed.
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5.
Step: for each theme and sub-theme, clear definitions were provided in relation to the literature.
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