Does Massage With or Without Aromatherapy Reduce Infant's Distress?

Study Overview
=================
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.

Official Title
-----------------
Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial

Conditions
-----------------
Distress

Intervention / Treatment
-----------------
* Other: aromatherapy massage


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively | Other: aromatherapy massage<br>* Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only<br>* Other names: B - massage;|
| Other: B<br>infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively | Other: aromatherapy massage<br>* Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only<br>* Other names: B - massage;|
| No Intervention: C<br>no intervention, standard postoperative care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of COMFORT with videotaped COMFORT behavior scale |  | first 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMFORT behavior bedside and Visual Analogue Scale distress, change in Heart Rate, change in Mean Arterial Pressure, amount of required sedatives/opioids |  | first 24 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
massage, aromatherapy, comfort, postoperative, infants, craniofacial surgery