Clinical trial NCT00624637: Does Massage With or Without Aromatherapy Reduce Infant's Distress?
Official title: Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Distress
Keywords: aromatherapy
massage
comfort
postoperative
infants
craniofacial surgery
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2008-02-27
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery

Exclusion Criteria:

* Neurological impairment
* Eczema or other skin disorders
* Nut allergy

Primary outcomes:
measure: level of COMFORT with videotaped COMFORT behavior scale
timeFrame: first 24 hours postoperative
Secondary outcomes:
measure: COMFORT behavior bedside and Visual Analogue Scale distress, change in Heart Rate, change in Mean Arterial Pressure, amount of required sedatives/opioids
timeFrame: first 24 hours postoperative
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Pediatric Surgical Intensive Care, Erasmus MC-Sophia
state: Zuid Holland
Study officials:
affiliation: Erasmus MC-Sophia
name: Dick Tibboel, prof, MD
role: STUDY_DIRECTOR
References:
citation: de Jong M, Lucas C, Bredero H, van Adrichem L, Tibboel D, van Dijk M. Does postoperative 'M' technique massage with or without mandarin oil reduce infants' distress after major craniofacial surgery? J Adv Nurs. 2012 Aug;68(8):1748-57. doi: 10.1111/j.1365-2648.2011.05861.x. Epub 2011 Nov 3.