Introduction
Many children feel anxious when they need to undergo a medical examination or intervention. In particular, needle related procedures cause anxiety and fear in children [
1‐
6]. This leads to more pain and emotional distress [
2‐
6]. Failure to adequately manage pain and anxiety may have immediate negative consequences such as unsuccessful medical procedures and lack of cooperation from a child, leading to increased procedural time and adverse physiological reactions [
3,
4,
6]. More far-reaching effects are increased pain perception, diminished analgesic effectiveness with subsequent procedures, and avoidance of medical care, which may persist into adulthood [
4,
6]. Besides negatively impacting the child, significant child pain and anxiety during needle procedures can be highly distressing and challenging for parents and healthcare providers as well [
7,
8].
In adults, the use of communication techniques based on hypnosis can be used to reduce pain and anxiety [
9,
10]. These methods are based on establishing instant rapport, avoiding negative suggestions and reframing using a script or guided imagination. These techniques can be integrated in everyday patient interaction and as a supplement on procedural sedation or perioperative care [
9‐
11]. Non-pharmacological psychological interventions for pain have also been investigated in children in the review of Birnie [
2]. Distraction, breathing, hypnosis and combined cognitive and behavioral strategies can reduce pain and distress during needle procedures. The results of this review, however, should be interpreted with caution due to lack of blinding of patients and of outcome assessors [
2]. To further examine the effects of communication techniques on procedural pain and comfort in children, more research is warranted.
Children experience medical procedures within the context of their family [
12]. This means that a child’s coping strategy and its expectations are related to that of its parents [
12]. So, when examining the effects of an intervention on pain and distress of the child, it is of importance to also assess the parent experience of this intervention (e.g., by measuring proxy pain, and self-reported and observed anxiety). Several studies have addressed the influence of parental anxiety on the child’s pain experience [
13‐
16]. For example, one of the studies showed that parent (pre)procedural anxiety increases the child’s anxiety during the procedure which ultimately caused more child’s pain [
13]. Therefore, in this study we will investigate the influence of parental anxiety on the child’s pain experience.
This study assesses the effects of therapeutic communication (TC) versus standard communication (SC). TC is based on Comfort Talk
®, the LAURS of hypnotic communication and the ''Lived in Imagination'' Technique in an outpatient setting [
9‐
11,
17,
18]. The objective of this study is to examine whether patient-centric TC positively affects children’s comfort during venipuncture. The primary outcome of this study is self-reported pain by children. Secondary outcomes are observed pain (child and parent), anxiety (child and parent), satisfaction (child, parents and medical personnel) and procedural time. Also, a mediation analysis will be conducted to investigate whether parents’ anxiety increases children’s pain through children’s anxiety. Finally, a subgroup analysis will be performed to investigate if TC is effective in neurodivergent children (e.g., with attention-deficit-hyperactivity-disorder (ADHD) or with autism spectrum disorder (ASD). This, to gain more insight in this topic as a considerable amount of children in our tertiary hospital is neurodivergent and there is lack of empiric evidence on patient comfort and venipuncture in these patients [
19].
Discussion
The objective of this study was to examine whether patient-centric TC positively affects children’s comfort during venipuncture. Comfort is defined as a ''transient and dynamic state characterized by ease from pain, emotional and physical distress and an emerging sense of positivity, safety, strength and acceptance of one’s situation that is underpinned and sustained by feeling valued, cared for, confident and accepting treatment. Patients seek to be as comfortable as they can be, under the circumstances of their healthcare interaction'' [
26]. When assessing patient’s experience during interventional procedures the word comfort avoids the nocebo effect of the word pain. Unfortunately comfort scores correlate only moderately with pain scores [
27]. Pain intensity and distress are considered primary outcomes for evaluating psychological interventions for needle-related procedures in children [
2]. Pain and fear are positively associated with each other. Fear can increase the pain experience and fear can increase during acute pain [
28]. The interdependence of these two variables made it difficult to decide which primary outcome should be defined. Because of the familiarity and routine measurement of pain scores in children in our hospital, we choose pain intensity as primary outcome measure.
No difference in self-reported pain was found between the SC and the TC group. For the secondary outcomes, however, scores significantly improved for anxiety, time in the room and satisfaction of the medical personnel. For the third research question, namely whether parental anxiety influences the child’s pain via the child’s anxiety, no mediation effect was found. For the fourth research question, we found that TC had the same effect on anxiety as in non-neurodivergent children.
The absence of significant self-reported pain results may be attributed to the overall low pain scores (95% CI [1.1, 2.4]), and these low pain scores did not indicate clinically relevant pain according to the optimal cut points for the FPS-R [
29]. The low pain scores are probably the result of the use of EMLA which is an effective local anesthetic for pediatric venipuncture pain [
30,
31]. This was implemented as standard procedure prior to venipuncture in our hospital. Literature varies on the effect of therapeutic communication/distraction techniques on pain, because these studies are difficult to compare as they differ in the use of EMLA, distraction technique, patient population and pain scores during venipuncture [
10,
32‐
34].
All anxiety scores for the child (scored by child 8 years or older), parent and medical personnel) were lower in the TC group than in the SC group. The parents also scored lower self-reported NRS anxiety scores when TC was used. NRS anxiety for the parent scored by the medical personnel did not differ significantly between groups. Moreover, this study investigated the influence of parental anxiety on the relationship between the child’s anxiety and pain experience. No mediation effects were found (parental procedural anxiety on child pain via child anxiety) in both groups. This is in contrast with the study results of Bearden et al. (2012) where a mediation effect was found of preprocedural anxiety and procedural pain of the child, which in turn heightened the child’s pain [
13]. This, again, may be due to the lack of higher pain scores in the current study. For satisfaction, this study found higher satisfaction for medical personnel in the TC group. We hypothesize that this higher satisfaction of the medical personnel was explained by more communication tools of the personnel to deal with anxious patients and their parents, which resulted in less delay and less stressful situations. Furthermore the personnel mentioned a better team climate and improved interaction between care givers themselves. However not investigated thoroughly in our study, this improved job satisfaction and better team climate was also described in other studies [
11,
35]. The shorter procedural time and no need for other resources makes this communication technique very suitable for application in the outpatient clinic and at the emergency department.
Finally, because a large proportion of patient undergoing venipuncture is neurodivergent (28.6% in our sample), and because of the limited research conducted on this topic, we performed a subgroup analysis to find out if TC was also effective in the neurodivergent children (e.g., with ASD or ADHD) in our study. The results showed similar effects in anxiety reduction for neurodivergent children as non-neurodivergent children. However, this result must be interpreted with caution, as this analysis was exploratory and the sample of the subgroup analysis was relatively small (n = 30).
One of the strengths of this study was that when examining comfort during venipuncture, this study captured the multi-faceted context of this procedure. Different outcomes were measured (e.g., pain, anxiety, and satisfaction) from different perspectives (children, parents and medical personnel) thereby adopting an overall integrative approach. Moreover, this study aimed to contribute to the scarce literature of venipuncture comfort for neurodivergent children. However, adopting this integrative approach induces bias. Given the large amount of outcome measures, the likelihood of incorrectly rejecting a null hypothesis (i.e., making a Type I error) increases [
36]. Furthermore, we recommend more emphasis on (neuro)divergent groups in future research, especially for children with ASD as these children often show higher levels of anxiety [
19,
37‐
39].
To conclude, our study found that with just a small change in communication style, the comfort of the child during venipuncture improves. This was mainly reflected by reduced anxiety scores and shorter procedural times, making the use of TC during venipuncture promising for the outpatient setting.
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