The International Consolidated Venous Ulcer Guideline Update 2015: Process Improvement, Evidence Analysis, and Future Goals

Demographic and burn characteristics. During the data collection period, 25 patients were treated in the authors’ unit. Of these, 10 were eligible for the study according to the inclusion and exclusion criteria. Participants included 8 men, 2 women, mean age 28.5 ± 13.7 (range 14–51) years; 6 were educated up to the secondary level, 3 up to primary level, and 1 was illiterate. Five (5) were unemployed, 6 were married, 7 had electric burns, and 3 had second-degree flame burn injury. The mean TBSA was 27% ± 19.0% (range 5%–60%). 

A total of 104 dressing changes (52 control, 52 experimental) were completed as study data points. The mean number of dressing changes of each participant was 10 ± 6.09 (range 2–18), 5 as part of the experiment (with music therapy) and 5 as control (without music therapy). The majority of the participants (7) chose spiritual music (gayatri mantra and shabad) for the therapy.

Procedural pain and anxiety outcomes. The overall pain score (median, IQR) for the experimental dressing changes (3, range 1–5) was significantly lower than for the control dressing changes (4.5, range 2–6) (P <.001) (see Table 1). Median state anxiety scores before the experimental dressing changes (12, IQR: 8-17) were significantly lower as compared to the control dressing changes (14, IQR: 10-19) (P <.001). The trait anxiety scores were not significantly different during the control and experimental dressing changes (see Table 2). 

Analgesic use outcomes. Most patients required analgesics during the dressing change. Of the total 104 dressing changes, an analgesic was provided 38 times in control group and 24 times in the experimental group. The frequency of opioid use was significantly lower during the experimental dressing change (9.6%) as compared to the control dressing change (34.6%), (P = .002) (see Table 3). Interestingly, the overall frequency of analgesic use was not reduced, but the type of medication changed. Patients were given weaker analgesics such as paracetamol more often during the experimental dressing change pertinent to the lower levels of pain perception. In all the patients, morphine was charted as 3 mg intravenously as needed. Thus, the objective to reduce the opioid use (as-needed use of morphine) was successfully achieved. 

Hemodynamic parameters outcomes. None of the hemodynamic parameters (blood pressure, heart rate, respiratory rate, temperature) was significantly different between the control and experiment groups (see Table 4). 

Since time immemorial, music has been widely used to enhance well-being, decrease emotional difficulties, and distract patients from symptoms such as pain.²⁴ Despite this fact, no studies have been conducted in India that explore the use of music therapy to relieve patient pain and anxiety during burn wound dressing changes. In the current study, every patient served as his or her own control. This helped ensure the control and experimental dressing changes had total homogeneity in terms of participant characteristics. As previously described, Fratianne et al¹⁴ employed a similar repeated measures design with patients serving as their own control to test the efficacy of music-based imagery and musical engagement to manage pain and anxiety during burn debridement. A quasi-experimental pilot study was conducted by Kahar et al²⁵ in Singapore to assess whether music helps reduce the pain experienced by burn patients during dressing changes. Using convenience sampling, 30 dressing changes were alternatively assigned to control (without listening to music) and experimental (listening to music) groups. The authors used the NRS, a pain behavioral tool, and physiological monitoring. The music was soothing and distracting, but its effects were not found to be statistically significant. The authors concluded that further high-quality studies are needed to evaluate the impact of music. Also, they did not allow patients to select the type of music; they acknowledged that allowing the patient to select the music may have enhanced the study. Thus, the current study was built on the work of Kahar et al²⁵ by using patient-selected music. Self-selected music also was used in the Son and Kim¹¹ and Wang et al¹⁹ studies. In the systematic review by Nilsson,¹⁸ 29 out of 42 studies used self-selected prerecorded music. However, researchers also have used live music^13,17 and participatory music interventions such as playing instruments or singing,^14,16 showing music therapy has a wide scope in terms of use and practice. 

Pain intensity was measured using a NRS because it frequently has been reported to be a useful tool.^17,18,22,26 The current study is in consonance with many previous studies in documenting that music has a significant role in reducing the intensity of pain among burn patients during dressing changes.^10,11,14,15 However, Whitehead-Pleaux et al¹³ reported that music therapy for pediatric patients during donor site dressing changes generated mixed results; therefore, the study was statistically inconclusive, suggesting more studies in pediatric burn patient populations are needed. The current study confirms that music therapy is effective in reducing pain, with results similar to studies exploring music in other patient populations besides burns.^17,18 

The STAT was used because it is a widely accepted, reliable, and valid tool.²³ A significant reduction was noted in the median state anxiety scores before the experimental dressing changes as compared to the control dressing changes (P <.001). These findings are in line with the Hsu et al¹⁰ and Son and Kim¹¹ studies that found significant reduction in anxiety scores of burn patients when music-related interventions were employed. Similar to the current findings, studies involving other patient populations also have found music to be useful in relieving anxiety.^16,19 However, the Whitehead-Pleaux et al¹³ and Fratianne et al¹⁴ studies differ; they both reported an improvement in the self-report of anxiety scores of the burn patients, but the difference was not significant. The Wang et al¹⁹ study utilized physiological measures of anxiety (eg, heart rate, blood pressure, electrodermal activity, serum cortisol levels) along with STAI. Further research using these physiological measures in burn patients is warranted.

In the present study, the frequency of opioid use was found to be significantly lower in the experiment group (P = .002). Because literature is scant regarding the effect of music therapy on opioid use among burn patients, further exploration to generate satisfactory evidence is warranted. None of the physiological parameters such as blood pressure, pulse, respiratory rate, and temperature — assessed in this study as secondary outcomes because they have been reported to be indirect measures of anxiety and pain¹⁹ — was significantly different between the control and experiment groups. Wang et al¹⁹ had similar findings, with no significant difference found in heart rate and blood pressure values (P = .5) between persons who did/did not have music therapy. However, Almerud and Petersson²⁷ reported a significant decrease in both systolic and diastolic blood pressure during music therapy sessions among intensive care unit patients temporarily on a respirator.

Lack of blinding (observer and patient) is a major concern. A larger number of patients is needed to increase the power of the study and determine if music truly has an effect on pain and anxiety. The small tertiary care unit provided services to patients of all ages (including neonates) from all over northern India; the majority of these patients have severe burn injuries and are either on inotropic or ventilator support. These patients were not included in this study because their anxiety and pain perception is not easily measurable, limiting the sample size of this pilot study. Further research in this dimension is under consideration, including a multicenter study.

Pain management in burn patients, which has both physiological and psychological outcomes,²⁸ is an ever-growing challenge faced by the burn care team. Music therapy can help reduce the level of pain, anxiety, and opioid use during dressing change among burn patients. Similar studies can be conducted in different research settings and different patient populations to include a larger sample size, and the effect of instrumental and lyrical music types can be compared. Future research would benefit from blinded observer assessment of pain and anxiety. Also, self-report of pain and anxiety can be compared with objective assessment by an observer. Generating further evidence with a larger sample size to support current and historic findings and facilitate the development of an evidence-based standard music therapy protocol is recommended.

Burn injury results from excessive exposure of tissue to thermal, chemical, electrical, or radioactive agents.^1,2 According to a relevant textbook,³ pain is integral to survival. Although no research describes the proportion of burn patients reporting inadequate pain relief, pain relief measures have been anecdotally reported to be insufficient in both adult^4-6 and pediatric⁷ burn populations, mainly due to fear of side effects and addiction to opioids, lack of routine pain evaluations, and standardized analgesic protocols.⁴ In their review article, Patterson et al⁵ recommended a structured approach to burn analgesia that includes performing routine pain assessment and incorporating both drugs and individualized alternative therapies based on psychological, cognitive behavioral, and operant learning techniques.⁸ A variety of psychological techniques such as hypnosis, relaxation, and music therapy may be helpful in managing burn pain by providing multimodal distraction.⁴ 

An exploratory study⁹ showed the effect of music therapy depends upon not only the type of music, but also upon the associations and memories of the music. Various studies performed in countries other than India have documented a positive effect of listening to music on burn patients’ pain and anxiety during dressing change. Hsu et al¹⁰ conducted a prospective, randomized controlled trial (RCT) (N = 70) to assess the impact of music on burn patients’ pain and anxiety at the time of dressing change. Patients were randomly assigned to 2 groups; the control group was provided standard interventions (ie, routine dressing change) and the experimental group listened to music during the routine dressing change. Pain and anxiety were assessed before, during, and after dressing change. Morphine use in both groups was recorded. A significant reduction in pain and anxiety was reported by the fourth day in the experimental group (P <.05), although morphine dosage remained the same in both groups. Similarly, in a quasi-experimental pretest-posttest design study by Son and Kim,¹¹ 32 patients were assigned into control (routine burn dressing changes) and experimental (listening to self-selected music during dressing changes) groups for 3 days. Pain and anxiety scores were self-reported using the State-Trait Anxiety Inventory (STAI)¹²; significant reductions were noted in both anxiety (P <.017) and pain scores (P <.012) before and after the dressing changes when patients listened to music in the experimental group as compared to the control group. 

Whitehead-Pleaux et al¹³ conducted a similar RCT study on pediatric patients. Fourteen (14) patients were randomly assigned to control (verbal interaction) and experimental groups (listening to live music). The participants of the experimental group anecdotally reported positive effects of music on pain and anxiety, although the difference in the pain and anxiety scores was not statistically significant between the experimental and control groups. Fratianne et al¹⁴ conducted a repeated measures study among 25 patients (age 7 years and older) serving as their own control to test the efficacy of music-based imagery and musical engagement (ie, activities such as listening to music, identifying or singing familiar songs, practicing deep breathing according to music rhythm, and playing simple musical instruments) in relieving pain and anxiety among burn patients during the debridement process. A significant reduction in self-reported pain was noted among persons who received music therapy versus those who did not (P <.03). Anxiety scores also improved, but the difference of the anxiety scores between the 2 groups was not statistically significant. 

A systematic review and meta-analysis¹⁵ of 17 RCTs (804 patients) on the effects of music intervention on burn patients found a significant positive effect of music intervention on pain alleviation (standard mean differences [SMD] = -1.26; 95% confidence interval [CI] -1.83 to -0.68), anxiety relief (SMD = -1.22; 95% CI -1.75 to -0.69), and heart rate reduction (SMD = -0.60; 95% CI [-0.84 to -0.36]). In a systematic review of 26 studies,⁶ 17 showed positive outcomes when nonpharmacological interventions were used to manage procedural pain among adult burn patients. 

Music therapy also has been documented to have a positive effect on pain and anxiety in patient populations other than burns. A repeated measures, pretest–posttest design study (N = 36 men) performed by Hwang and Oh¹⁶ compared 3 different types of music therapy (singing, listening to music, and playing instruments for 30 minutes, twice a week for 6 weeks) on levels of depression, anxiety, anger, and stress among alcohol-dependent clients. The authors reported participant anxiety scores were significantly reduced with music therapy (P <.05). Gutgsell et al¹⁷ conducted a RCT (N = 200) to assess the efficacy of a single music therapy session to reduce pain in palliative care patients. A significant decrease (P <.0001) was noted in the numeric rating scale (NRS) pain scores in the music therapy group.

Nilsson¹⁸ conducted a systematic review of 42 RCTs published from 1995 to 2007 on the effects of music therapy on pain and anxiety in the perioperative period among patients undergoing elective surgery. The type of music employed was soothing (ie, not more than 60 to 80 beats per minute); in 29 studies, a patient self-selected music. In 19 studies, the STAI¹² was used to assess anxiety. In the 22 studies that evaluated the effect of music on pain, a visual analogue scale was most commonly used (n = 12); other instruments used to measure pain included a NRS, the McGill Pain Questionnaire, and a verbal rating scale. The results showed (as demonstrated in approximately ~50% of the outcomes) music intervention had a positive effect on reducing patient anxiety and pain in the perioperative setting. 

A RCT by Wang et al¹⁹ evaluated the effect of music therapy on preoperative anxiety. The experiment group (n = 48) listened to 30 minutes of patient-selected music 30 minutes before the surgery and self-reported anxiety using the STAI; physiological measures of anxiety included heart rate and blood pressure. Results showed music therapy reduced anxiety levels of the patients in the experimental group by 16% compared with their pre-interventional level. The reduction in the anxiety scores in the experimental group as compared to the control group was also statistically significant (P =.001). In a review of the literature by Henry,²⁰ music therapy was found effective in decreasing pain and anxiety related to acute illness, injury, and painful procedures among critical care patients.

The current authors noted a lack of clinical evidence regarding use of music therapy among burn patients in India and conducted a study to assess the effect of music therapy on pain, anxiety, and opioid use among patients admitted in a tertiary care hospital in northern India.

In the August 2018 column,¹ we shared our early experience with the newly introduced product Endoform Antimicrobial (manufactured by Aroa Biosurgery Limited, Auckland, New Zealand, and distributed by Appulse; www.appulsemed.com). This month’s column updates our use of Endoform Antimicrobial for early intervention and describes a change to the nonantimicrobial variant, Endoform Natural.

Control of bioburden via debridement and use of advanced extracellular matrix (ECM) technologies is gaining recognition as a proactive early wound care intervention.² This strategy is important not only for existing chronic wounds, but also because it decreases the risk of acute wounds becoming chronic. Facilitating this approach has been the development of advanced wound care technologies, most notably Endoform. The ECM technology of the Endoform product family augments the wound healing phases (ie, hemostasis, inflammation, proliferation, and remodeling [see Figure 1]) by stabilizing the wound bed, rebalancing wound proteases to correct inflammation, scaffolding cell infiltration to build new tissue, and organizing the deposition of new healing tissue; it also includes secondary molecules important to healing (eg, fibronectin and hyaluronic acid). In short, Endoform Natural and Endoform Antimicrobial (a 0.3% silver variant) have been shown to complement all phases of wound healing from early stabilization of the wound bed through resolution of inflammation and finally to scaffolding cell infiltration and closure of the tissue deficit (see Figure 1). 

The launch of Endoform Antimicrobial has provided a new opportunity for our wound care clinic to intervene early using an antimicrobial then advance to a neutral ECM once we are satisfied the wound is stabilized. In 2012, an Expert Working Group³ proposed the “14-day challenge” that describes conservative use of silver-based dressings in wound care. The consensus paper recommends use of silver-based products for 14 days, after which time either the silver dressing is discontinued based on positive changes in the wound bed or silver is continued and the wound reassessed on a weekly basis. This guidance has become one of the gold standards in wound care and addresses growing concerns related to the potential overuse of silver in the wound care sector, the potential for silver resistance, and the known detrimental effects of silver on cell viability. 

We have implemented the proactive use of Endoform Antimicrobial from day 1 using a 14-day challenge during which time the wound is assessed for wound bed and bioburden stabilization; essential wound care, including wound bed preparation through debridement and maintaining a moist wound environment, also is implemented.⁴ After the initial 14-day challenge period, the wound is provided Endoform Natural and managed using this ECM until closure. Because not all wounds or patients are the same and wound treatment can be unpredictable, we have found having 2 Endoform products allows great flexibility so we can individualize our interventions. 

Case Study

A 57-year-old woman with diabetes presented with a chronic ulcer measuring 2.0 cm x 2.0 cm x 0.4 cm, with exposed capsule and approximately 4 weeks old. The wound was debrided and management with Endoform Antimicrobial was initiated (see Figure 2). Endoform Antimicrobial was applied every 2 to 7 days and the wound assessed weekly for infection and progression of the granulation tissue. 

After 3 weeks, the wound had reduced in size to 2.0 cm x 1.5 cm x 0.4 cm as the epithelial margins were migrating inward (see Figure 3). At this point, management with Endoform Natural was initiated. The wound continued to improve with weekly applications of Endoform Natural and without visible signs of infection.