Distress Clinical Trial
Official title:
Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial
This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress
Despite extensive use of pharmacological treatments such as sedatives, distress and anxiety
remain a huge problem in patients admitted to the PICU, especially in the 65% under the age
of 3. Parents are anxious about the outcome and feel powerless because they have to transfer
care to doctors and nurses. Those in favor of complementary care, realize at the same time
that there is lack of evidence to support its use in daily practice. On the other hand, many
sedatives used in infants are unlicensed and animal studies even suggest increased risk of
neuroapoptosis using midazolam at an early age.
In a first study we will evaluate the effects of aromatherapy massage or massage compared to
standard care in infants after craniofacial surgery.
The first group receives: aromatherapy massage using a concentration of mandarin essence in
the massage oil, the second group: massage (without essential oils) and the third (control)
group receives standard postoperative care. Massage will be performed in a standardized way
using the ' m' technique® developed by dr. Buckle. Primary outcome is the percentage of
patients with COMFORT behavior score below 17, assessed from videomaterial by a rater blinded
for condition.The intervention will be carried out three hours after return from
surgery.Secondary outcomes are bedside COMFORT behavior scores assessed by the caregiving
nurse and the amount of midazolam used in the first 24 hours postoperative as well as the use
of additional analgesics such as paracetamol and morphine.
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