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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Erasmus Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00624637
First received: February 15, 2008
Last updated: February 25, 2008
Last verified: February 2008

February 15, 2008
February 25, 2008
January 2008
December 2009   (final data collection date for primary outcome measure)
level of COMFORT with videotaped COMFORT behavior scale [ Time Frame: first 24 hours postoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00624637 on ClinicalTrials.gov Archive Site
COMFORT behavior bedside and Visual Analogue Scale distress, change in Heart Rate, change in Mean Arterial Pressure, amount of required sedatives/opioids [ Time Frame: first 24 hours postoperative ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Distress
Other: aromatherapy massage
Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only
Other Names:
  • A - aromatherapy massage
  • B - massage
  • A
    infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively
    Intervention: Other: aromatherapy massage
  • B
    infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively
    Intervention: Other: aromatherapy massage
  • No Intervention: C
    no intervention, standard postoperative care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
6 Months to 3 Years
No
Contact: Marjan de Jong, RN 4636151 m.dejong.3@erasmusmc.nl
Contact: Monique van Dijk, Dr 4636066 m.vandijk.3@erasmusmc.nl
Netherlands
 
NCT00624637
2007-253
No
Dr Monique van Dijk, Erasmus MC-Sophia Children's Hospital
Erasmus Medical Center
Not Provided
Study Director: Dick Tibboel, prof, MD Erasmus MC-Sophia
Erasmus Medical Center
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP