Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Erasmus Medical Center |
---|---|
Information provided by: | Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT00624637 |
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 IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial |
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
|
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
|
C: No Intervention
no intervention, standard postoperative care
|
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.
Ages Eligible for Study: | 6 Months to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marjan de Jong, RN | 4636151 | m.dejong.3@erasmusmc.nl |
Contact: Monique van Dijk, Dr | 4636066 | m.vandijk.3@erasmusmc.nl |
Netherlands, Zuid Holland | |
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 |
Study Director: | Dick Tibboel, prof, MD | Erasmus MC-Sophia |
Responsible Party: | Erasmus MC-Sophia Children's Hospital ( Dr Monique van Dijk ) |
Study ID Numbers: | 2007-253 |
Study First Received: | February 15, 2008 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00624637 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
aromatherapy massage comfort |
postoperative infants craniofacial surgery |