Study location. The study was conducted in an 8-bed burn unit of a tertiary level hospital (Post Graduate Institute of Medical Education and Research, Chandigarh, North India) during July and August 2015.
Study design. A quasi-experimental, cross-over (repeated measures) design was employed. Every burn dressing change was considered a study data point. In order to ensure complete homogeneity of the control and experiment group, each patient undergoing dressing changes served as his/her own control. All the patients irrespective of their post burn day were identified and screened for eligibility using the inclusion and exclusion criteria. The enrolled patients had a control dressing change on the first day of assessment. Following the cross-over design, the same patients went through an experimental dressing change on the third day (ie, during their next dressing change), and this cycle was repeated until discharge. Each patient was studied for approximately 10 days. The washout period was an important consideration in the cross-over design; dressing changes were performed at least 48 hours apart to reduce recall bias among the patients.
Participants. Using the total enumeration technique, all the dressing changes performed in the burn unit during the study period were assessed. Inclusion criteria stipulated study participants must be burn patients >10 years old, conscious, able to respond, and oriented to time, place, and person. Burn patients on ventilator support, hearing impaired, and/or declared hemodynamically unstable by the attending plastic surgeon were excluded. In addition, patients had the choice of opting out of the study at any time if they were not comfortable with the intervention. Had this occurred, they would have been reported as drop outs.
Conceptual framework. The conceptual framework for this research plan was based on Melzack and Wall’s Gate Control Theory of Pain.21 This theory proposes that pain can be reduced by stimulating sensory neurons, which are larger and faster than pain neurons and effectively close the gate-carrying pain stimuli. Cognitive processes such as distraction reduce pain perception by consuming attention and stimulating the sensory neurons.12
Study tools. The primary outcome variables were pain, anxiety, and opioid use during the burn dressing change. Secondary outcome variables were hemodynamic parameters. An interview/assessment schedule was prepared to obtain patient sociodemographic (age, gender, education, occupation, and marital status) and burn profile (etiology and degree of burn, total burn surface area) data; these data were validated by experts from nursing education and clinicians from the department of plastic surgery of the authors’ institute. Using a NRS,22 a standardized ordinal level scale was used to measure pain perception. Patients rated their pain from 0 to 10, where 0 means no pain and 10 means extremely intolerable pain. The Indian version of the State-Trait Anxiety Test (STAT), developed by Vohra,23 of the STAI for adults developed by Speilberger et al,12 was used to assess patient anxiety levels 30 minutes before dressing changes. The STAT is a standardized tool with established reliability and validity.23 Forty (40) items (20 measuring state anxiety and 20 measuring trait anxiety) are used to calculate the score. State anxiety is defined as an emotional state that exists at a given moment in time (ie, how the respondent feels “right now, at this moment,” in this case immediately before the dressing change). Trait anxiety is described as the likelihood of the person to experience anxiety when perceiving a stressful situation as dangeous or threatening.12 Total scores for state and trait sections separately range from 20 to 80, with higher scores denoting higher levels of anxiety.23
Care protocol. According to routine protocol of the unit, dressings are changed on patients in the burn unit every other day. Patients are bathed with water and a betadine scrub, and the dressing change is performed by the attending plastic surgeon. The wounds are dried using sterile dressing pads (gauze dressing wrapped over cotton). Antibiotic ointment (silver sulfadiazine or colloidal silver) then is applied over the wounds. The wound areas then are covered with a double layer of sterile dressing pads (12 inch x 12 inch) and the dressing is secured using sterile (6-inch) bandages. The routine pain management in the unit included pharmacological interventions prescribed by the physician and administered to the patients as needed.
The burn unit’s analgesic routine was not manipulated during the study. The drug name, dosage, and route of the analgesics administered to the patients by the burn unit team during the dressing change were recorded per se. A clinical assessment proforma was developed to collect data about hemodynamic parameters (blood pressure, pulse rate, respiration, and temperature) using the cardiac monitors of the unit. All of the above study tools were paper/pencil instruments, and the questions were asked by the investigator who completed the forms.
Music therapy protocol. A protocol for music therapy during burn dressing change was prepared on the basis of a review of literature and suggestions from medical experts. As advocated in literature, nonlyrical instrumental music pieces8,17 were included in the therapy under 4 classes: Spiritual/religious (Bhajans and Sikhism shabad), Western instrumental (guitar, piano), Classical instrumental (tabla, flute, sitar), and Bollywood instrumental (ajeeb dastan hai ye, khamoshiyan). The 15 music pieces were assessed by 20 nursing research experts. The experts were asked individually to rate each music piece by giving it a score out of 10 for suitability to be used in music therapy in the patient population (1 = unsuitable and 10 = most suitable). The scores for each music piece were totalled and the music pieces with the lowest scores were eliminated, leaving 10 instrumental music pieces. The patient was given an opportunity to listen to all the music pieces on the first day of therapy; the music selection made by the patient was used every time s/he received music therapy during the experimental dressing change.
The music was played using MP3 players and earphones at the bedside of the patient 30 minutes before and for 30 minutes after each dressing change. Ear phones were used to help the patient focus on the music and to remove distracting sounds of the burn unit (eg, cardiac monitors or people talking). The MP3 players and earphones were kept separate for each patient and were cleaned with alcohol swabs before and after use to prevent infections. Ear phones were used at bedside, and loudspeakers were used where dressings were changed. During control dressing changes, patients received standard care as per the unit’s protocol.
Ethical considerations. The research protocol was approved by the Ethics Review Committee of the institute. Informed written consent was obtained from all participants after explaining the research, objectives, and duration of the study. All the participants were informed about their right to refuse to participate or withdraw from the study at any time. Patient anonymity and confidentiality were maintained while collecting data and reporting the study by restricting data access to the core investigators. Nothing interfered with the routine treatment of the participants. Care was taken not to cause any harm or discomfort to them. The STAT was purchased with legal rights of use. The study was registered with the Clinical Trials Registry of India (Registration number: CTRI/2016/09/007281).
Data collection and analysis. The sociodemographic (gender, age, employment status, marital status, level of education), burn profile (type of burn, percent of body affected; ie, total burn surface area [TBSA]), and hemodynamic variable (blood pressure, heart rate, respiration, and temperature) data were collected by interview and clinical assessment. Using the NRS, patient pain scores were recorded 3 times: 30 minutes before, during, and 30 minutes after the dressing change. To obtain the pain score during dressing change, patients were asked to rate their overall pain during the procedure after the dressing change was over; this score was analyzed using median and interquartile range (IQR) data. Degree of anxiety was determined 30 minutes before burn dressing change as per the total score obtained on STAT. Analgesic use was recorded and classified into 2 categories for purposes of analysis: opioids (eg, tramadol, morphine) and nonopioids (eg, paracetamol and diclofenac sodium). The hemodynamic parameters were assessed at 3 instances: 30 minutes before, during, and 30 minutes after dressing changes.
The data collected were directly entered into the Statistical Package for Social Sciences (SPSS for Windows, version 16.0, Chicago, IL) for statistical analysis. Descriptive analysis was used for the sociodemographic and burn profile data to assess frequency and percentage. Because the data did not follow normal distribution, nonparametric tests were used, with a level of significance of 0.05. The median values of pain, anxiety, and hemodynamic parameters of the control and experimental groups were compared using Wilcoxon test. The frequency of opioid use between the control and experimental dressing change was compared using chi-squared test. Post hoc analysis of the power of the study was performed using the “Gpower” software, version 3.0.10 (Universität, Dusseldorf, Germany). With an effect size of 0.5, with the given sample size of 52, a power of 0.95 was achieved.