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
  Purpose

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


Condition Intervention Phase
Distress
Other: aromatherapy massage
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • level of COMFORT with videotaped COMFORT behavior scale [ Time Frame: first 24 hours postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively
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
B
infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively
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
No Intervention: C
no intervention, standard postoperative care

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.

  Eligibility

Ages Eligible for Study:   6 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624637

Contacts
Contact: Marjan de Jong, RN 4636151 m.dejong.3@erasmusmc.nl
Contact: Monique van Dijk, Dr 4636066 m.vandijk.3@erasmusmc.nl

Locations
Netherlands
Pediatric Surgical Intensive Care, Erasmus MC-Sophia Recruiting
Rotterdam, Zuid Holland, Netherlands, 3000 CB
Principal Investigator: Marjan de Jong, RN         
Sub-Investigator: Monique van Dijk, Dr         
Principal Investigator: Dick Tibboel, Prof, Dr         
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Study Director: Dick Tibboel, prof, MD Erasmus MC-Sophia
  More Information

No publications provided by Erasmus Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Monique van Dijk, Erasmus MC-Sophia Children's Hospital
ClinicalTrials.gov Identifier: NCT00624637     History of Changes
Other Study ID Numbers: 2007-253
Study First Received: February 15, 2008
Last Updated: February 25, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Erasmus Medical Center:
aromatherapy
massage
comfort
postoperative
infants
craniofacial surgery

ClinicalTrials.gov processed this record on October 29, 2014