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

Erasmus University

Status and phase: Unknown; Phase 4

Conditions: Distress

Treatments: Other: aromatherapy massage

Study type: Interventional

Funder types: Other

Identifiers

NCT00624637

2007-253

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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110 participants in 3 patient groups

A

Other group

Description:

infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively

Treatment:

Other: aromatherapy massage

B

Other group

Description:

infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively

Treatment:

Other: aromatherapy massage

C

No Intervention group

Description:

no intervention, standard postoperative care