key: cord-333061-d1mdacx3
authors: Zhang, Xiu-Hang; Cui, Chang-Lei; Lee, Kai-Ki; Chen, Xin-Xin; Yu, Jia-Ao; Wu, Wei-Wei
title: A Specially Designed Medical Screen for Children Suffering from Burns: A Randomized Trial of a Distraction-type Therapy
date: 2020-05-30
journal: Burns
DOI: 10.1016/j.burns.2020.05.018
sha: 
doc_id: 333061
cord_uid: d1mdacx3

Abstract Objective To evaluate the impact of the specially designed medical dressing screen during wound dressing changes of children who suffered burns to their hand or foot. Design Randomized controlled trial. Setting Burns and Plastic Reconstruction Unit. Participants Children (N=120) with burns on up to 1%-5% of the total body surface area. Interventions The patients were selected and randomly allocated to 3 equal-sized groups as follows:control group (N=40): the children received only regular dressing changes; computer group (N=40): a touch-screen computer was used for children during dressing changes; medical screen group (N=40): a medical screen combined with the touch-screen computer were used for children during dressing changes. All patients underwent a dressing change once per day for four days. Data were distributed four times: immediately after the initial dressing change (T1); and immediately after each times at next three consecutive days (T2-T4). Main Outcome Measures The Pain level of the children evaluated by medical staffs was the primary outcome, the Pain level of the children evaluated by children's parents and the satisfaction of wound therapist were used as second outcomes. Results The mean scores related to pain level at the medical screen group displayed significantly better results than those of control group and those of the computer group. Additionally, the results of the pain evaluated by parents and satisfaction score of the wound therapist at the medical screen group was also better than other groups. Conclusions This study demonstrated “that the” application of the medical screen for burns can relieve the pain of 1-3 years old children suffering from a burns during dressing changes. Additionally, the application of the medical screen also increased the satisfaction of the parents and the wound therapist performing the dressing changes.

In developing countries, children under the age of 5 can account for 50-80 % of all children patients, 1 while the 52 morbidity rate of children 3 years old or younger with burn injuries is the highest in China. [2] [3] [4] Studies show that burns 53 rank 5th among non-vulnerability injuries for children with resultant irreversible complications such as pain, anxiety 54 and depression. 5 Of these complications, pain is considered to be among the most debilitating sequelae of the burn 55 injury. 6-7 56 57 Burn pain is a special kind of pain with the fiercest intensity of all types. Specifically, pain during wound dressings can 58 be excruciatingly painful and has been considered to be the most painful among all non-surgical procedures. [8] [9] During 59 wound dressing, children can express panic, crying, resistance, etc. due to dressing pain and fear of dressing because 60 their psychological development is immature and lack the ability for autonomous cooperation, which resulted in great 61 inconvenience for clinical work. 10 62 63 Pharmacological treatment is the primary approach for relieving pain related to burns, and several categories of drugs 64 have been used to manage burn pain and psychological symptoms caused by pain. However, due to the variability of 65 the intensity of pain in children, the symptoms remain under-treated. 10 Recently, much attention has been paid to pain 66 management approaches with non-pharmacological therapies. Distraction is a common non-pharmacological pain 67 treatment method that is commonly used in children. Currently, there are different types of distraction 68 including music video, visual image, electronic games , etc., which can intervene with the pain when dressing changes 69 are performed for children with burns, and the effect is relatively good. [11] [12] [13] Research studies have indicated that 70 distraction can transfer the attention of children to something more attractive to relieve pain, what's more, it has an 71 apparent effect in relieving pain for children with burns. 11 J o u r n a l P r e -p r o o f a function of a screen with a touch-screen computer to design and build a medical dressing screen for children aged 1-3 77 years who are suffering from a burns on their hand or foot and require dressing changes, aimed to provide 78 recommendations for future research and clinical practice. 79

The single-center randomized controlled trial was conducted in our hospital from January 2019 to September 2019. 83

The study was designed to compare the effect of a specially designed medical dressing screen's intervention with usual 84 care or a touch-screen computer alone during wound dressing changes for children aged 1-3 years who suffering from 85 burns on their hands or feet. 86 87

The sample size was estimated to be 40 subjects for each group with 80% power, an alpha value of 0.05, and an 89 attrition rate of 10% and Cohen's d = 0.59 (medium effect size). 14 Following the children parents' agreement to 90 participate, they were thoroughly screened for eligibility by the main researcher. Children between 1 and 3 years old 91 with burns on their hands or feet who came to our department for treatment were selected for tiral. Burns were 92 limited to a single hand or foot, with the burnt area <5 % total body surface area (TBSA) and a burned depth of second-93 or third-degree. Children were excluded if (1) had a confirmed past of cognition or psychological disorders, (2) had an 94 abnormal neurogenesis or abnormal cutaneous sensation, (3) previous burn injuries. A flow diagram of the study is 95 shown in Figure 2 . 96 J o u r n a l P r e -p r o o f a 6 the purpose and method of the study, children's parents were informed about the right to withdraw from the study at 103 any time with no penalties or sanctions. All data collection and management procedures took into account the 104 participants' right to privacy and confidentiality. The authors confirm that all ongoing and related trials for this 105 intervention are registered. 106 107

A total of 137 children were initial included in this study, as 5 children who did not meet the inclusion criteria and 12 109 parents refused to participate in the clinical experiment, 120 children were finally included in this study. Written 110 informed consent was obtained from each parent after providing a detailed introduction of the study, but we did not 111 provide a detailed explanation of the differences in intervention among groups. After obtaining informed consent, the 112 children were randomly divided into 3 equal-sized groups according to the use of our permutation block design, which 113 was created by a computer random number generator with a balanced randomized of 1:1:1, and the sample size of 114 each group was 40. 115 116

Interventions 118

For all groups,information was gathered from the parents about their child's daily interests and hobbies, including 119 types and names of music, animation, videos, situational dialogues or electronic games. Additionally, the demographic 120 and clinical characteristics of children were also recorded via a brief interview. The nurse also introduced actions of J o u r n a l P r e -p r o o f a On the initial day, a routine dressing change (T1) was performed (including all children were treated with the same 128 oral narcotics (tramadol) based on weight (Kg), and all the periods were administered by the same anesthesiologist. 129

However, different methods were used at T2-T4 as follows. For the computer group (N=40), in addition routine dressing changes as usual, a touch-screen computer was used 134 during dressing changes (parents guided the child to watch the programme content on the touch-screen computer 135 according to child's daily interests and hobbies which were prepared in advance.). 136

137 For the medical screen group (N=40), in addition routine dressing changes, the medical screen combined with the 138 touch-screen computer was used for children during the dressing changes. Before dressing changes, the medical 139 dressing screen for burns was moved to the location of the dressing treatment. The universal wheel on the lower part 140 of the screen was locked to firmly fix the screen so that its location could completely cover the wound therapist. The 141 touch-screen computer was installed and powered on to play the content that was prepared for children in advance. 142

The wound therapist entered the dressing room ahead of time to prepare. Then, the nurse informed the parents to 143 take their child into the dressing room (only the parents and the child were allowed to enter the dressing area and to 144 seat on the adjustable seat.). Then, the parents guided the child to watch the programme content on the touch-screen 145 computer according to child's daily interests and hobbies which were prepared in advance. When the child's attention locking capability are at the bottom of the screen, and the screen appearance is designed with an animation pattern. 159

The screen is equipped with a height adjustable seat. Additionally, in order to facilitate wound dressing, the screen is 160 also equipped with 3 windowsfor the right upper limb, the left upper limb and the lower limbs so that wounds can be 161 conveniently exposed for dressing. 162

The conditions of all groups should be matched as closely as possible to control for confounding variables and 164 minimal-to-no interruptions occurred. To reduce rater bias, dressing changes were performed by the same skilled 165 wound therapist according to the specific wound type in the same treatment room. In addition, the medical screen for 166 burns was disinfected after each dressing change. Any complications and adverse effects related to intervention were 167 also recorded. In addition, wound therapist's satisfaction score (pain levels) was also evaluated by the VNS, from 0-11 scores, the 187 higher the satisfaction, the higher the score. 188

The evaluation of MBPS during dressing changes was performed by 2 nurses with more than 10 years of experience 190 and 1 doctor with more than 10 years of experience by examining the children's performance in the video during the 191 dressing change (we did not provide a detailed explanation of the differences in intervention among groups). The pain 192 evaluated by parents was evaluated by the accompanying parents after each dressing change immedicately (T1-T4). 193

The wound therapist's satisfaction score was evaluated by the wound therapist after T1-T2 dressing changes. Table 4 shows the overall satisfaction of the wound therapist, there were significant differences between medical 234 screen group and computer groupby intra-group comparison at T1 and T2 (all p<0.001), but no difference at control 235 group (p=0.564). In addition, there was significant differences at the wound therapist score at T2 by inter-group 236 comparison (p <0.001), but no difference at T1 (p=0.13). 237 238   Table 4 . Assessment of the wound therapist score in three groups at T1 and T2. year). As shown in Table 2 , although the conventional analgesics were injected, the pain experience during the 249 dressing change in both groups was very strong. Duo to physicians often prescribe inadequately potent analgesics or 250 inadequate doses of analgesics. The reasons for this are multi-factorial, with the primary concern that the use of drugs 251 may harm children, as a result, the limited control of pain. [17] [18] In addition to being intrinsically very painful, repeated 252 dressing changes can promote anxiety, making subsequent changes even more distressing. 11-12, 18 253 254 Additionally, psychological expressions, such as panic, crying and screaming result from a lack of a sense of safety due 255 to the memory of pain from past treatment when face medical workers. 19 Thus, if patients do not receive effective pain 256 relief, physiological problems may result and negatively affect their perseverance in treatment. 20 Therefore, to reduce 257 children's crying during the procedure, an intervention should be performed to reduce children's memory of pain 258 resulting from the medical staff. 259

As the Table 2 shown, there were significant differences in the scores of pain at T2, T3 and T4 by inter-group 261 comparison (all p <0.001), but no difference at T1 (p=0.499). The findings indicate that with respect to phenomena 262 related to burn dressing changes, the medical screen have a significant influence in comparison with other groups as 263 the Table 2 shown. 264

In addition, it could be observed from the videos that most of the children in the control or computer group started to 266 have expressions including frowning, closing their eyes, limb tensions, crying, screaming and other escaping resistance 267 actions when they entered the dressing room even before the dressing change was performed. On the contrary, most 268 of the children in the medical screen group were immediately guided to watch the programme content played on the 269 computer screen after they entered dressing room thereby the expressions above were reduced. Interestingly, it could 270 be seen that most of children's crying could be reduced in the medical screen group after the parents played many kinds of programmes on the screen for pain intervention when the dressing was uncovered and bound up, except for 272 when the wound was disinfected. in each group at each time point in Figure 3 and the inter-group and intra-group comparisons in Table 2 In our view, the working pressure for medical workers in the burn department is higher than that in other 293 specialties, 23 and the mental stress is mainly from children's degree of cooperation during dressing and the degree of 294 recognition from parents. 24 The application of the medical screen for burn children in this study not only reduced such This study has shown that this method is effective and user-friendly, however, the study results should be interpreted 301 in light of its limitations. In this small sample clinical trial study, the use of a single site may be considered study 302 limitations. Second, as patients are likely to be lost to continued monitoring, this study only assessed the effect of a 303 3-day intervention. Therefore, it is essential that future research for longer periods of time. Third, the lack of blinded 304 assessments by the clinicians should be a limitation (although complete blinding may not be possible). Additionally, 305

perhaps there were differences in pain levels to begin with (as the cause of burn differed slightly, though not 306 significantly), this should be another limitation. Last but not the least, in the early stage of this study, all ages of 307 children were included, and it was found that children aged 1-3 were the most affected, so the age was set at 1-3 years 308 old. In this regard, a large number of studies still need to be further explored. 309

According to the result of the present study, this paper strengthens relevant research, which might open the door to 312 the development of methods that can treat children burn patients in the future and so it stands to reason that the 313 special designed medical screen could have longer term efficacy. Despite the limited number of previous studies 314 investigating this topic 11 , the current results provide further evidence that the special designed medical screen is more 315 effective than touch computer or usual care, suggesting that this will be a powerful and effective complement 316 treatment method for minimizing pain in children burn patients related to dressing changes. Based on the findings of 317 the current study, we recommend the special medical screen can be used as a method of complement due to its 

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MD:mean difference;CI:confidence interval; ‡Kruskal-Wallis test