Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of an Aromatherapy Intervention on Sleep in the ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623686
Recruitment Status : Unknown
Verified December 2015 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Sleep Deprivation Other: Aroma Therapy Massage and Inhalation Patch Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: What is the Effect of an Aromatherapy Intervention on Sleep in the ICU? An Exploratory Study
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Aroma group
  • 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.
Other: Aroma Therapy Massage and Inhalation Patch
No Intervention: Control Group
Normal Care



Primary Outcome Measures :
  1. • Differences in RCSQ patient scores [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. • Difference in BIS scores [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623686


Locations
Layout table for location information
United Kingdom
The Royal Marsden NHS Foundation Trust Not yet recruiting
London, United Kingdom, SW3 6JJ
Contact: Natalie Pattison, Surrey    020735281711154    Natalie.Pattison@rmh.nhs.uk   
Contact: Amyn A Lalji    +447746133379    amyn.lalji@rmh.nhs.uk   
Sub-Investigator: Jeannie Dyer, MSc, BA,         
Sub-Investigator: Timothy Wigmore         
Principal Investigator: Natalie Pattison, DNSc, MSc,         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust

Layout table for additonal information
Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02623686     History of Changes
Other Study ID Numbers: CCR 4308
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Keywords provided by Royal Marsden NHS Foundation Trust:
Sleep
ICU
Massage Therapy
Inhalation Patch
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders