Does Massage With or Without Aromatherapy Reduce Infant's Distress? (aromatherapy)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- level of COMFORT with videotaped COMFORT behavior scale [ Time Frame: first 24 hours postoperative ] [ Designated as safety issue: No ]
- 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:
|
|
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:
|
|
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 |
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| Contact: Marjan de Jong, RN | 4636151 | m.dejong.3@erasmusmc.nl |
| Contact: Monique van Dijk, Dr | 4636066 | m.vandijk.3@erasmusmc.nl |
| 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 | |
| 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 May 21, 2013