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van CCT (UK)

van CCT (UK)

Does massage with or without essential oils enhance relaxation in hospitalized children with burn injuries in South Africa?

- candidate number14634
- NTR NumberNTR3929
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-mrt-2013
- Secondary IDsWO/13.103 
- Public TitleDoes massage with or without essential oils enhance relaxation in hospitalized children with burn injuries in South Africa?
- Scientific TitleMassage with our without aromatherapy in children with burns: A randomized controlled trial.
- hypothesisWe hypothesize that massage with aromatherapy or massage with carrier oil enhances relaxation whereas no intervention does not. We hypothesize that massage with essential oils is more effective than massage without essential oils.
- Healt Condition(s) or Problem(s) studiedPediatric burn patients, Massage
- Inclusion criteria1. Burns greater 19%, burns of face, hands, feet, genitalia, perineum and major joints, electrical and chemical burns, inhalation injury, circumferential burns;
2. Patients are admitted to the burns unit of the Red Cross War Memorial Children's Hospital in Cape Town.
- Exclusion criteria1. Patients whose parents do not give informed consent for the study and patients > 11 years who are not willing to participate;
2. Patients who are considered not to respond well to massage due to the type of trauma (intentional injury);
3. Burn area too large and not enough unburned or healed skin available;
4. Children being prepared for theatre or just having returned from theatre;
5. Children already sleeping;
6. Older children saying they did not want treatment;
7. Younger children – especially toddlers – who show extreme fear when strangers approach them;
8. Children who have not yet been stabilized.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-apr-2013
- planned closingdate1-okt-2014
- Target number of participants300
- InterventionsTwo massage interventions will be compared to control condition. One includes massage with grapeseed oil only. The other, the aromatherapy massage condition will be performed with essential oils in grape seed oil. Essential oils: a blend of Lavender (Lavendula angustifolia), German Chamomile (Matricaria recutica) and Neroli (Citrus arantium) essential oil.
- Primary outcomeThe primary outcome is the mean difference between before and after massage behavioral scores from videotaped material assessed by a researcher who is blind for treatment allocation.
Assessment instruments:
1. Muscle Tension Inventory: The Muscle Tension Inventory (MTI) has been validated by Tan et al. (2010) in burn patients aged 8 to 71 years of age.(Tan, Yowler et al. 2010) The MTI evaluates muscle tension of each of 8 body areas (forehead, eyes, facial expression, mouth/jaw, head/neck, chest, arms, legs) on a scale from 1 (relaxed) to 5 (tense) giving a total score between 8 to 40;
2. Behavioral Relaxation Scale: The Behavioral Relaxation Scale (BRS) has been validated in adults and children (Schilling and Poppen 1983; Raymer and Poppen 1985; Norton, Holm et al. 1997). It consists of a description of 10 postures or behaviors characteristic of a fully relaxed person: 1) breathing – scored as relaxed if less than the baseline rate; 2) quiet – no vocalizations; 3) body – no movement of the trunk; 4) head in midline; 5) eyes – closed with smooth eyelids; 6) jaw – lips parted in center; 7) throat – no movement; 8) shoulders – sloped and even, no movement; 9) hands – curled in ‘claw like’ position; 10) feet – pointed away from each other forming an approximate 90° angle. The total score ranges from 0 (totally relaxed) to 50 (totally not relaxed) with lower scores indicating greater relaxation;
3. COMFORT behavior scale: The COMFORT behavior scale (van Dijk, de Boer et al. 2000; Ista, van Dijk et al. 2005) has been validated in children between 0-to-3 years of age. It consists of six items: 1. Alertness; 2. Calmness; 3. Respiratory response (for ventilated children) or Crying (for spontaneously breathing children); 4. Body movements; 5. Facial tension; and 6. Muscle tone. Each item has five response alternatives rated 1 to 5 representing the different intensities of the behavior in question. Summating the six ratings leads to a total score, theoretically ranging from 6 to 30.
- Secondary outcomeThe secondary outcome will be change in oxygen saturation and heart rate between before and after massage/control condition. A handheld pediatric Pulse Oximeter (Clinical Guard®, OctiveTech 300AH) will be used to record heart rate and oxygen saturation.
- TimepointsAssessments will be performed during 2 minutes before massage/control condition and 2 minutes after massage. Each child will be assessed across 5 massage/control sessions across 2 weeks.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Nederlandse Brandwondenstichting
- Funding
(Source(s) of Monetary or Material Support)
Dutch Burn Society
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD30-mrt-2013 - 15-jan-2016

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