RESUMEN
Needle-related procedures can cause pain and fear in children and may lead to avoidance of future medical care. The aim of this study is to investigate whether virtual reality hypnosis (VRH) is non-inferior to medical hypnosis (MH) by a trained healthcare provider in reducing pain in children. This non-inferiority randomized trial was conducted at a teaching hospital in the Netherlands. Children aged 6 to 18 years were randomized to treatment with VRH or MH. The primary outcome was self-reported pain, using the Wong-Baker FACES Scale (WBFS) with the non-inferiority margin defined as a difference of 1.5 points. Secondary outcomes included observer-reported pain (Numeric Rating Scale), fear (scored by children and observers with the Children's Fear Scale), blood pressure, heart rate, treatment satisfaction, and adverse effects. We randomized 138 children to VRH or MH treatment and included 114 children in the analyses (VRH n = 60, MH n = 54). We found non-inferiority for VRH compared to MH on patient-reported pain (mean difference = - 0.17, 95%CI - 1.01;0.66). Secondary outcomes were comparable between VRH and MH groups. Both treatments scored high on patient satisfaction (VRH median = 9.0, MH median = 10.0, p = 0.512). CONCLUSION: VRH may be an effective and safe treatment option besides MH for reducing patient-reported pain in children during a needle-related procedure. VRH was non-inferior to MH in patient-reported fear and both treatments were comparable in terms of patient-reported fear, observer-reported pain and fear, physical distress, and patient satisfaction. TRIAL REGISTRATION: ICTRP https://trialsearch.who.int/ , trial ID NL9385; date registered: 03/04/2021. WHAT IS KNOWN: ⢠Medical hypnosis is effective in reducing procedural distress in children during needle-related procedures. ⢠Virtual reality (VR) is an audiovisual electronic device that guides users into an immersive three-dimensional environment. WHAT IS NEW: ⢠This study shows that VR hypnosis is non-inferior to medical hypnosis in reducing pain and fear in children undergoing a needle-related procedure. ⢠Both VR hypnosis and medical hypnosis were appreciated highly by children to distract them during needle-related procedures.