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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively |
|
| B | Other | infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively |
|
| C | No Intervention | no intervention, standard postoperative care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aromatherapy massage | Other | Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only |
|
| Measure | Description | Time Frame |
|---|---|---|
| level of COMFORT with videotaped COMFORT behavior scale | first 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| COMFORT behavior bedside and Visual Analogue Scale distress, change in Heart Rate, change in Mean Arterial Pressure, amount of required sedatives/opioids | first 24 hours postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marjan de Jong, RN | Contact | 4636151 | m.dejong.3@erasmusmc.nl | |
| Monique van Dijk, Dr | Contact | 4636066 | m.vandijk.3@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Dick Tibboel, prof, MD | Erasmus MC-Sophia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Surgical Intensive Care, Erasmus MC-Sophia | Recruiting | Rotterdam | South Holland | 3000 CB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22050553 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 4, 2012 | |
| Reset | Apr 2, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 4, 2012 | Apr 2, 2012 |
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