Massage has no observable effect on distress in children with burns: A randomized, observer-blinded trial

Importance In a previous observational study we found that massage therapy reduced anxiety and stress in pediatric burn patients. We aimed to test this effect in a randomized controlled trial. Objective To determine whether (1) aromatherapy massage can provide relaxation to hospitalized children with burns; (2) massage with aromatherapy oil is more effective than without; and (3) massage sessions are more effective when repeated. Design, setting, and participants Randomized controlled clinical trial with 3 arms conducted in a burns unit from April 2013 to December 2014 in Cape Town, South Africa. Interventions Massage with carrier oil, massage with aromatherapy oil, and standard nursing care only. Main outcomes and measures Scores on the Muscle Tension Inventory (MTI) and Behavioral Relaxation Scale (BRS) to assess level of relaxation. Scores on the COMFORT behaviour scale and Numeric Rating Scale Distress to assess level of distress. Secondary outcomes were heart rate and oxygen saturation levels. Linear mixed models were used to determine the effect of condition and session number (1 to a maximum of 5 sessions per child) correcting for baseline outcomes of COMFORT behaviour scores and heart rates after sessions. Secondary analyses included the addition of sex, age, and total body surface area (TBSA) burned as covariates. Results We included 284 children aged 5 weeks to 13 years with TBSA burned between 10 and 45%. Two-thirds (65.5%) were under the age of 3 years. Mixed model analyses revealed no significant difference in reduction of COMFORT behavior scores (p=0.18), or heart rates (p=0.18) between the three study arms. These outcomes were also not associated with the session number (p=0.92 and p=0.13, respectively). Level of relaxation could not be reliably assessed with the MTI and BRS because 119 patients (41.9%) had bandages covering the larger part of the face, and in 40.1% of cases the child was not in the required position. Conclusion and relevance Massage therapy with or without essential oil was not effective in reducing distress behavior or heart rate in hospitalized children with burns. Evaluating the effectiveness of massage in terms of relaxation proved difficult in young children. Trial registration The Netherlands National Trial Registry: NRT3929.