The Effect of an Aromatherapy Intervention on Sleep in the ICU

Sleep Deprivation Clinical Trial

Official title:

What is the Effect of an Aromatherapy Intervention on Sleep in the ICU? An Exploratory Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02623686
• Other study ID #: CCR 4308
• Status: Not yet recruiting
• Phase: N/A
• First received: December 3, 2015
• Last updated: December 7, 2015
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: December 2015
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Other:
• Aroma Therapy Massage and Inhalation Patch

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Differences in RCSQ patient scores		24 months	No
Secondary	• Difference in BIS scores		24 months	No