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

Phase 4

• Conditions: Distress
• Interventions: Other: aromatherapy massage

• Registration Number: NCT00624637
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2008-02
• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-25
• Last Update Submitted: 2008-02-25
• Study First Posted: 2008-02-27
• Last Update Posted: 2008-02-27
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A	aromatherapy massage	infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively
B	aromatherapy massage	infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively

Primary Outcome Measures

Name	Time	Method
level of COMFORT with videotaped COMFORT behavior scale	first 24 hours postoperative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pediatric Surgical Intensive Care, Erasmus MC-Sophia; 🇳🇱 Rotterdam, Zuid Holland, Netherlands