The aim of this study was to examine whether therapeutic communication improves children's comfort during venipuncture compared to standard communication. This study was registered in the Dutch trial register (NL8221), December 10, 2019. This single-blinded interventional study was carried out in an outpatient clinic of a tertiary hospital. Inclusion criteria were age between 5 and 18 years, use of topical anesthesia (EMLA) and sufficient understanding of the Dutch language. 105 children were included, 51 assigned to the standard communication group (SC group) and 54 patients to the therapeutic communication group (TC group). The primary outcome measure was self-reported pain based on the Faces Pain Scale Revised (FPS-R). Secondary outcome measures were observed pain (numeric rating scale (NRS)), self-reported/observed anxiety in child and parent (NRS), self-reported satisfaction in child, parent and medical personnel (NRS), and procedural time. No difference was found for self-reported pain. Self-reported and observed anxiety (by parents and medical personnel) was lower in the TC group (p-values ranged from p = 0.005 to p = 0.048). Procedural time was lower in the TC group (p = 0.011). Satisfaction level of medical personnel was higher in the TC group (p = 0.014).   Conclusion: TC during venipuncture did not result in lower self-reported pain. However, secondary outcomes (observed pain, anxiety and procedural time) were significantly improved in the TC group. What is Known: • Medical procedures, especially needle related procedures, cause anxiety and fear in children and adults. • In adults communication techniques based on hypnosis are effective in reducing pain and anxiety during medical procedures. What is New: • Our study found that with a small change in communication technique (called therapeutic communication or TC), the comfort of children during venipuncture improves. • This improved comfort was mainly reflected by reduced anxiety scores and shorter procedural time. This makes TC suitable for the outpatient setting.

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