Study design and sample. Using convenience sampling methods, consecutive patients from a WCC were randomly assigned to control (no music) and intervention (music) groups. The start date of the study was December 1, 2019. The end date of the study was Feburary 28, 2020. Verbal consent was obtained from all patients while they were in the WCC waiting room. Patients were then randomly assigned to rooms 1 to 6 according to their arrival time and room availability. For patients assigned to rooms 1 to 3 (intervention group), classical music was played in the examination room during treatment. The patients assigned to rooms 4 to 6 (control group) received their treatments but no music was played. Classical music was selected because it was reported to be effective in promoting relaxation.20
Inclusion criteria were patients who 1) had chronic wounds and were seen in the WCC for routine outpatient visits and dressing changes and 2) were alert and oriented with no hearing problems. Exclusion criteria consisted of having cognitive deficits or psychiatric disorders as well as taking pain and/or anti-anxiety medication 8 hours before the wound care clinical visits.
State-Trait Anxiety Inventory (STAI). This scale was developed by Spielberger et al21 to measure trait and state anxiety; it can be used in clinical settings to diagnose anxiety and to distinguish anxiety from depressive syndromes.
The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures 2 types of anxiety: state anxiety, or anxiety about an event, and trait anxiety, or anxiety as a personal characteristic. The state anxiety items include, “I am tense; I am worried,” and “I feel calm; I feel secure.” All items are rated on a 4-point scale (eg, from “almost never” to “almost always”). Higher scores indicate greater anxiety. The STAI-Y1 is appropriate for those who have at least a sixth-grade reading level. Internal consistency coefficients for the scale range from 0.86 to 0.95; test-retest reliability coefficients range from 0.65 to 0.75 over a 2-month interval.21 Test-retest coefficients in this study for this measure ranged from 0.69 to 0.89. In addition, Considerable evidence attests to the strong construct and concurrent validity of the scale.22
Setting. The study was conducted in a busy WCC of a nonprofit academic medical center in the northeastern United States. A total of 222 patients with chronic wounds were included. The objectives were explained to each participant. After obtaining verbal consent, the pretreatment state anxiety level and blood pressure were measured in the waiting room by one trained registered nurse (RN) working in the WCC. Based on their arrival time and room availability, participants were randomly assigned to either rooms 1 to 3 as the intervention group (n = 112; classical music was played during treatment) or rooms 4 to 6 as the control group (n = 110; no music was played during treatment). After treatment, the state anxiety level and blood pressure were remeasured by the RN.
Ethical considerations. Study approval was obtained from the institutional review board at the medical center before the study began. Only verbal consent was required by the board. All essential components were explained to the participants, including study goals, procedure, sponsorship, potential risks, potential benefits, confidentiality and privacy, data sharing, conflict of interest disclosure, and contact information. The information provided to the patients was consistent with the participants’ comprehensive level to ensure understanding. The STAI is appropriate for those who have a sixth-grade reading level. Participants’ right to privacy and confidentiality were protected throughout the process.
Statistical analysis. To calculate the minimum sample size, the G*Power (Heinrich Heine University, Düsseldorf, Germany) sample size formula was conducted using the t test, difference between 2 dependent means, 2 tails test, moderate effect size, and a desired power of .90 at the alpha level of .05. Once the minimum sample size for each group was established, the researchers ensured enough study participants to strengthen the study. All data were collected using paper instruments and entered for data analysis into the Statistical Package for the Social Sciences (SPSS) 25 software program (IBM). Descriptive statistics were used to analyze patient demographic variables. Pre- and post-test STAI scores as well as systolic and diastolic blood pressure measurements were compared using the paired sample t-test.