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The Effect of an Aromatherapy Intervention on Sleep in the ICU

Primary Purpose

Sleep Deprivation

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Aroma Therapy Massage and Inhalation Patch
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Deprivation focused on measuring Sleep, ICU, Massage Therapy, Inhalation Patch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aroma group

Control Group

Arm Description

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.

Normal Care

Outcomes

Primary Outcome Measures

• Differences in RCSQ patient scores

Secondary Outcome Measures

• Difference in BIS scores

Full Information

First Posted
December 3, 2015
Last Updated
December 7, 2015
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02623686
Brief Title
The Effect of an Aromatherapy Intervention on Sleep in the ICU
Official Title
What is the Effect of an Aromatherapy Intervention on Sleep in the ICU? An Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
Sleep, ICU, Massage Therapy, Inhalation Patch

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aroma group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Normal Care
Intervention Type
Other
Intervention Name(s)
Aroma Therapy Massage and Inhalation Patch
Primary Outcome Measure Information:
Title
• Differences in RCSQ patient scores
Time Frame
24 months
Secondary Outcome Measure Information:
Title
• Difference in BIS scores
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Pattison, Surrey
Phone
020735281711154
Email
Natalie.Pattison@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Amyn A Lalji
Phone
+447746133379
Email
amyn.lalji@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Jeannie Dyer, MSc, BA,
First Name & Middle Initial & Last Name & Degree
Timothy Wigmore
First Name & Middle Initial & Last Name & Degree
Natalie Pattison, DNSc, MSc,

12. IPD Sharing Statement

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The Effect of an Aromatherapy Intervention on Sleep in the ICU

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