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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00624637
Acronym
aromatherapy
Enrollment
110
Registered
2008-02-27
Start date
2008-01-31
Completion date
2009-12-31
Last updated
2008-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distress

Keywords

aromatherapy, massage, comfort, postoperative, infants, craniofacial surgery

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.

Interventions

Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only

Sponsors

Erasmus Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 3 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
level of COMFORT with videotaped COMFORT behavior scalefirst 24 hours postoperative

Secondary

MeasureTime frame
COMFORT behavior bedside and Visual Analogue Scale distress, change in Heart Rate, change in Mean Arterial Pressure, amount of required sedatives/opioidsfirst 24 hours postoperative

Countries

Netherlands

Contacts

Primary ContactMarjan de Jong, RN
m.dejong.3@erasmusmc.nl4636151
Backup ContactMonique van Dijk, Dr
m.vandijk.3@erasmusmc.nl4636066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026