DistressPhase 4aromatherapyNCT00624637
Does Massage With or Without Aromatherapy Reduce Infant's Distress?
A Phase 4 study testing aromatherapy massage in people with Distress, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Distress
- What is being tested?
- aromatherapy massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery
Who cannot join
- Neurological impairment
- Eczema or other skin disorders
- Nut allergy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Pediatric Surgical Intensive Care, Erasmus MC-Sophia
Rotterdam, South Holland, 3000 CB
Marjan de Jong, RN
Monique van Dijk, Dr
About this study
Official title: Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial
This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress
Read the 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.
- Conditions
- Distress
- Being tested
- aromatherapy massage
- Keywords
- aromatherapy, massage, comfort, postoperative, infants, craniofacial surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapy massageOther
Also called A - aromatherapy massage, B - massage
Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only
| Study group | Role | What they receive |
|---|---|---|
| A | Other | infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively Receives: Other: aromatherapy massage |
| B | Other | infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively Receives: Other: aromatherapy massage |
| C | No intervention | no intervention, standard postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of COMFORT with videotaped COMFORT behavior scale
Measured: first 24 hours postoperative
Secondary outcomes (1)
COMFORT behavior bedside and Visual Analogue Scale distress, change in Heart Rate, change in Mean Arterial Pressure, amount of required sedatives/opioids
Measured: first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DistressStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Dick Tibboel, prof, MD, Study director, Erasmus MC-Sophia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624637
- Sponsor's protocol ID
- 2007-253
- Acronym
- aromatherapy
- Status last verified
- Feb 2008
- First submitted
- 15 Feb 2008
- Last updated
- 27 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22050553
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00624637
- Acronym / sponsor ID
- aromatherapy / 2007-253
- Conditions
- Distress
- Keywords
- aromatherapy, massage, comfort, postoperative, infants, craniofacial surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Other | Other: aromatherapy massageinfants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively |
| B | Other | Other: aromatherapy massageinfants after craniofacial surgery receive one massage with carrier oil three hours postoperatively |
| C | No intervention | –no intervention, standard postoperative care |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery
Key exclusion criteria (3 listed)
- Neurological impairment
- Eczema or other skin disorders
- Nut allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aromatherapy massageAlso: A - aromatherapy massage, B - massageTen minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only | Other | A, B |
Primary outcome
level of COMFORT with videotaped COMFORT behavior scale
Time frame: first 24 hours postoperative
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2008.
- Derived from this study: PubMed 22050553de 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dick Tibboel, prof, MD study director
Erasmus MC-Sophia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aromatherapy massage in people with Distress, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marjan de Jong, RN (4636151, m.dejong.3@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of COMFORT with videotaped COMFORT behavior scale (time frame: first 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00624637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2008.