Sleep DeprivationNCT02623686
The Effect of an Aromatherapy Intervention on Sleep in the ICU
A study testing Aroma Therapy Massage and Inhalation Patch in people with Sleep Deprivation, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
It is known from the literature that patients in the Intensive Care Unit do not get enough sleep impacting on short and longterm recovery (Tembo \& Parker, 2009; Bihari et al, 2012; Kamdar et al, 2012). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Aroma Therapy Massage and Inhalation Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jan 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any NHS patient with cancer admitted to the CCU during the period of the study
- aged 18 years or over
- who wishes to take part in the study
Who cannot join
- expected length of stay < 4 days
- habitual use of sleep medication more than 3 times per week
- no sleep meds/hypnotics allowed during study period
- no sedation during intervention period (propofol; clonidine; midazolam)
- extensive brain metastases/hypoxic or traumatic brain injury
- sleep apnoea
Show all 12Show fewer
- excessive alcohol consumption >50 units/week (ascertained via notes)
- extensive wound/skin damage that precludes massage (e.g. drug-related bullae/skin desquamation)
- neuromuscular blockade
- any normal massage contraindications including: severe respiratory or hemodynamic instability, GCS <7*, ICP <20* mmHg, no contraindication for changing in body position (including active significant bleeding etc)
- allergies to the use of essential oils, either on the skin or inhaled, precluding the use of both of the study blends
- allergy to base (grapeseed) oil
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, London, SW3 6JJ
Natalie Pattison, Surrey, 020735281711154, Natalie.Pattison@rmh.nhs.uk
Amyn A Lalji, +447746133379, amyn.lalji@rmh.nhs.uk
About this study
Official title: What is the Effect of an Aromatherapy Intervention on Sleep in the ICU? An Exploratory Study
It is known from the literature that patients in the Intensive Care Unit do not get enough sleep impacting on short and longterm recovery (Tembo \& Parker, 2009; Bihari et al, 2012; Kamdar et al, 2012). The use of non-pharmacological interventions such as massage with essential oils is supported by the literature as being useful in encouraging sleep (Richards et al, 2003; Matthews, 2011). Over 30% of cancer patients are accessing complementary therapies such as these (Rees et al, 2000; Lewith et al, 2002). We propose investigating whether aromatherapy massage and the use of essential oils in the form of an Inhalation Patch (Bioesse TM) prove to be a useful intervention for improving patient sleep whilst on the critical care unit.
Read the detailed description
A search of the literature shows that patients in the ICU specifically do not get enough sleep. The causes for this are multifactorial and include nursing and medical procedures, pain, discomfort, anxiety, stress, mechanical ventilation, the ICU environment including noise and light, pharmacological agents and severity of underlying disease (Tembo \& Parker, 2009; Bihari et al, 2012; Kamdar et al, 2012). Sleep disruption, along with inability to communicate and limitations on visiting, were rated as stressors by ICU patients (Nelson et al, 2001). The effects of poor sleep are deleterious, impacting on patients' recovery both within the ICU (Tembo \& Parker, 2009; Bihari et al, 2012) and subsequently after discharge (Kamdar et al 2012). Measurements on mechanically ventilated patients receiving continuous intravenous sedation showed disturbed Circadian timing, lack of REM sleep and absent EEG features of the alternation of wake and sleep states, suggesting that these patients may be continuously sleep deprived which could exacerbate their condition and compromise their recovery (Gehlbach et al, 2012). There is a preponderance of evidence suggesting that sedation practices may impact a range of adverse outcomes; novel strategies to combat patient symptomatology through non-pharmacologic means are to be encouraged (Millelsen \& Schweickert, 2013).Furthermore, the positive effect on anxiety of therapeutic touch using massage on ICU patients has been demonstrated previously in two RCTs (Henricson et al, 2008; Lindgren et al, 2013).The use of non-pharmacological strategies to encourage sleep is suggested by a number of authors (Gosselink et al, 008; Matthews, 2011; Kamdar et al, 2012). Richards (1998) found back massage useful for promoting sleep in critically ill older men; Nerbass et al (2010) found massage improved sleep post coronary artery bypass graft surgery;Soden et al (2004) found sleep scores of palliative care patients with cancer significantly improved with aromatherapy massage and massage alone, despite the fact that the massage interventions were given in the morning. Sleepdisruption can be exacerbated by factors such as pain, anxiety and stress (Kamdar et al, 2012). Massage may influence sleep partly because of its effects on these symptoms; a review by Ernst (2009) concluded that massage may help with symptom control including the reduction of anxiety and pain in cancer palliation and supportive care.Stringer et al (2008) found a single session of massage for isolated hematology patients undergoing intensive chemotherapy brought a significant reduction in cortisol with an accompanying improvement in psychological well-being.
- Conditions
- Sleep Deprivation
- Being tested
- Aroma Therapy Massage and Inhalation Patch
- Keywords
- Sleep, ICU, Massage Therapy, Inhalation Patch
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aroma Therapy Massage and Inhalation PatchOther
| Study group | Role | What they receive |
|---|---|---|
| Aroma group | Experimental | * two massages delivered within a two day period
* the patient will choose the essential oils used from blend A and blend B (if no choice is made, therapist will choose blend A and B alternately). One drop of the essential oil blend will be added to 5 mls of grapeseed base oil.
* an Inhalation Patch with the same blend of oils as used in the massage will be left by the therapist for use on each of the two nights following the aromatherapy massage intervention. Its use will be explained to the patient and to the member of nursing staff. The Inhalation Patch will be applied to the patient's upper chest when it is time to sleep at approximately 11 pm and will be removed the following morning at approximately 6 am. Receives: Other: Aroma Therapy Massage and Inhalation Patch |
| Control Group | No intervention | Normal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Differences in RCSQ patient scores
Measured: 24 months
Secondary outcomes (1)
• Difference in BIS scores
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623686
- Sponsor's protocol ID
- CCR 4308
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of an Aromatherapy Intervention on Sleep in the ICU? An Exploratory Study
- ClinicalTrials.gov ID
- NCT02623686
- Acronym / sponsor ID
- CCR 4308
- Conditions
- Sleep Deprivation
- Keywords
- Sleep, ICU, Massage Therapy, Inhalation Patch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 8 Dec 2015 (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.
It is known from the literature that patients in the Intensive Care Unit do not get enough sleep impacting on short and longterm recovery (Tembo \& Parker, 2009; Bihari et al, 2012; Kamdar et al, 2012). The use of non-pharmacological interventions such as massage with essential oils is supported by the literature as being useful in encouraging sleep (Richards et al, 2003; Matthews, 2011). Over 30% of cancer patients are accessing complementary therapies such as these (Rees et al, 2000; Lewith et al, 2002). We propose investigating whether aromatherapy massage and the use of essential oils in the form of an Inhalation Patch (Bioesse TM) prove to be a useful intervention for improving patient sleep whilst on the critical care unit.
Detailed description
A search of the literature shows that patients in the ICU specifically do not get enough sleep. The causes for this are multifactorial and include nursing and medical procedures, pain, discomfort, anxiety, stress, mechanical ventilation, the ICU environment including noise and light, pharmacological agents and severity of underlying disease (Tembo \& Parker, 2009; Bihari et al, 2012; Kamdar et al, 2012). Sleep disruption, along with inability to communicate and limitations on visiting, were rated as stressors by ICU patients (Nelson et al, 2001). The effects of poor sleep are deleterious, impacting on patients' recovery both within the ICU (Tembo \& Parker, 2009; Bihari et al, 2012) and subsequently after discharge (Kamdar et al 2012). Measurements on mechanically ventilated patients receiving continuous intravenous sedation showed disturbed Circadian timing, lack of REM sleep and absent EEG features of the alternation of wake and sleep states, suggesting that these patients may be continuously sleep deprived which could exacerbate their condition and compromise their recovery (Gehlbach et al, 2012). There is a preponderance of evidence suggesting that sedation practices may impact a range of adverse outcomes; novel strategies to combat patient symptomatology through non-pharmacologic means are to be encouraged (Millelsen \& Schweickert, 2013).Furthermore, the positive effect on anxiety of therapeutic touch using massage on ICU patients has been demonstrated previously in two RCTs (Henricson et al, 2008; Lindgren et al, 2013).The use of non-pharmacological strategies to encourage sleep is suggested by a number of authors (Gosselink et al, 008; Matthews, 2011; Kamdar et al, 2012). Richards (1998) found back massage useful for promoting sleep in critically ill older men; Nerbass et al (2010) found massage improved sleep post coronary artery bypass graft surgery;Soden et al (2004) found sleep scores of palliative care patients with cancer significantly improved with aromatherapy massage and massage alone, despite the fact that the massage interventions were given in the morning. Sleepdisruption can be exacerbated by factors such as pain, anxiety and stress (Kamdar et al, 2012). Massage may influence sleep partly because of its effects on these symptoms; a review by Ernst (2009) concluded that massage may help with symptom control including the reduction of anxiety and pain in cancer palliation and supportive care.Stringer et al (2008) found a single session of massage for isolated hematology patients undergoing intensive chemotherapy brought a significant reduction in cortisol with an accompanying improvement in psychological well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aroma group | Experimental | Other: Aroma Therapy Massage and Inhalation Patch* two massages delivered within a two day period * the patient will choose the essential oils used from blend A and blend B (if no choice is made, therapist will choose blend A and B alternately). One drop of the essential oil blend will be added to 5 mls of grapeseed base oil. * an Inhalation Patch with the same blend of oils as used in the massage will be left by the therapist for use on each of the two nights following the aromatherapy massage intervention. Its use will be explained to the patient and to the member of nursing staff. The Inhalation Patch will be applied to the patient's upper chest when it is time to sleep at approximately 11 pm and will be removed the following morning at approximately 6 am. |
| Control Group | No intervention | –Normal Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- any NHS patient with cancer admitted to the CCU during the period of the study
- aged 18 years or over
- who wishes to take part in the study
Key exclusion criteria (12 listed)
- expected length of stay < 4 days
- habitual use of sleep medication more than 3 times per week
- no sleep meds/hypnotics allowed during study period
- no sedation during intervention period (propofol; clonidine; midazolam)
- extensive brain metastases/hypoxic or traumatic brain injury
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 |
|---|---|---|
| Aroma Therapy Massage and Inhalation Patch | Other | Aroma group |
Primary outcome
• Differences in RCSQ patient scores
Time frame: 24 months
1 secondary outcome
• Difference in BIS scores
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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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.
The Royal Marsden NHS Foundation Trust
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aroma Therapy Massage and Inhalation Patch in people with Sleep Deprivation, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 12 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 8 Dec 2015. 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 United Kingdom. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Differences in RCSQ patient scores (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.