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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00624637
Other study ID # 2007-253
Secondary ID
Status Unknown status
Phase Phase 4
First received February 15, 2008
Last updated February 25, 2008
Start date January 2008
Est. completion date December 2009

Study information

Verified date February 2008
Source Erasmus Medical Center
Contact Marjan de Jong, RN
Phone 4636151
Email m.dejong.3@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 110
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 6 Months to 3 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Pediatric Surgical Intensive Care, Erasmus MC-Sophia Rotterdam Zuid Holland

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary level of COMFORT with videotaped COMFORT behavior scale first 24 hours postoperative
Secondary 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
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