Does Massage With or Without Aromatherapy Reduce Infant's Distress?
NCT ID: NCT00624637
Last Updated: 2008-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
110 participants
INTERVENTIONAL
2008-01-31
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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A
infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively
aromatherapy massage
Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only
B
infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively
aromatherapy massage
Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only
C
no intervention, standard postoperative care
No interventions assigned to this group
Interventions
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aromatherapy massage
Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Eczema or other skin disorders
* Nut allergy
6 Months
3 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Erasmus MC-Sophia Children's Hospital
Principal Investigators
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Dick Tibboel, prof, MD
Role: STUDY_DIRECTOR
Erasmus MC-Sophia
Locations
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Pediatric Surgical Intensive Care, Erasmus MC-Sophia
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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References
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de Jong M, Lucas C, Bredero H, van Adrichem L, Tibboel D, van Dijk M. Does postoperative 'M' technique massage with or without mandarin oil reduce infants' distress after major craniofacial surgery? J Adv Nurs. 2012 Aug;68(8):1748-57. doi: 10.1111/j.1365-2648.2011.05861.x. Epub 2011 Nov 3.
Other Identifiers
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2007-253
Identifier Type: -
Identifier Source: org_study_id