Pregnant Women Clinical Trial
Official title:
Exploring an Aromatherapy Intervention in an Acute Care Setting
This study aims to explore how the use of inhaled essential oils impacts the experience of a
laboring and postoperative surgical patient. It is expected that the aromatherapy
intervention will decrease levels of nausea, anxiety, and improve the perception of being
cared for in laboring mothers and patients recovering from surgery. By learning more about
aromatherapy, the investigators may be able to expand the aromatherapy intervention to more
patients in other Massachusetts General Hospital departments.
20 laboring patients will be recruited on admission to the labor and delivery inpatient unit.
They will be invited to participate in this study by nurses caring for them.
20 postoperative surgical patients will be recruited on admission to the surgical inpatient
unit. They will be invited to participate in this study by nurses caring for them
Aromatherapy is a complementary integrative intervention that can be incorporated into
nursing care to optimize health. It is defined as the use of essential oils, obtained from
aromatic plants, for therapeutic properties. Most State Boards of Nursing recognize clinical
aromatherapy as part of holistic nursing. There are benefits of using aromatherapy for
nausea, comfort, wellbeing, perception of care and anxiety which are common symptoms
associated with hospitalized patients.
Hospitalized patients often report a myriad of symptoms and increasingly ask for alternative
ways to manage them. According to the National Center for Complementary and Integrative
Health (NCCIH), a national survey in the United States. Four national surveys report that a
third or more of US adults routinely use complementary and alternative medicine (CAM)
therapies (e.g. chiropractic, massage, yoga, supplements, acupuncture) to treat their
principal medical conditions with total expenditures exceeding $34 billion in 2007. A global
shift in healthcare is moving toward wider acceptance of a philosophical value-guided health
approach that includes a whole-person/whole-system caring healing health perspective .
Complementary therapies have become more widely known and used in western healthcare. The
human consciousness shift toward wellness is allowing models and possibilities of inner
healing and emotional and mental health.
Despite widespread use and acceptance of complementary therapies in community settings, there
is some resistance to implementing such strategies in the acute care setting. There are no
reports of randomized clinical trials supporting such interventions in acute care settings.
Some evidence exists to support some complementary and integrative interventions.
One intervention that is cost effective and non-invasive is aromatherapy. While research
indicates that the use of aromatherapy has been effective in managing nausea, anxiety, and
discomfort, there are limited rigorous studies supporting its use in the acute care setting.
More work is needed to understand if aromatherapy is a feasible intervention to implement in
the acute care setting. Further research is needed to explore which essential oils are most
effective for symptom management in patients in the acute care setting.
Two groups of patients that commonly report anxiety, discomfort and nausea are postoperative
surgical patients and laboring obstetric patients. This study will explore the use of
aromatherapy as an intervention used by nurses to assist laboring obstetric patients and
postoperative elective surgical patients manage symptoms of nausea, anxiety, and discomfort.
Aromatherapy will serve as an adjunct and not as a replacement for standard routine care.
For many women, having a baby provides their first experience as a patient in a hospital
setting. Many women are hesitant to utilize pharmacological methods to decrease pain,
anxiety, and nausea associated with their labor experience due to fear of harming their baby.
As such, women increasingly turn to complementary therapies such as aromatherapy as a means
of retaining control over their childbirth experience. Odor has a direct pathway to the
limbic part of the brain, in particular to the amygdala that governs fear. Familiar smells
such as lavender may be calming and soothing at stressful times such as during childbirth.
Surgery is another stressful time for patients.
Much of the limited research on aromatherapy is two decades old. A British evaluative study
of 8,058 mothers delivering in a large teaching hospital between 1990 and 1998 indicated that
lavender aromatherapy relieved feelings of anxiety and fear (61%), pain (6%), improved
contractions (6%), reduced feelings of nausea and vomiting (14%) and improved general
well-being (7%). Lavender, frankincense and rose were found to relieve anxiety in labor.
There is some evidence that aromatherapy has been successfully used by midwives to reduce the
level of anxiety during the antepartum period. In a clinical randomized trial of 100 women in
labor, the level of anxiety of women in both the intervention (P=0.03) and control (P=0.003)
groups after the intervention was reduced after the intervention. Findings from these studies
also indicate that there were minimal to no side effects.
Post-operative nausea and vomiting (PONV) continue to be a major cause of patient
dissatisfaction affecting hospitalized patients. Although conventional approaches can be very
effective in managing PONV, some patients are intolerant of drug side effects or decline use
the medications. There is some evidence that inhalation of lavender, ginger, peppermint and
other oils are alternative techniques that have been used successfully with postoperative
patients in helping to manage discomfort and nausea. It is suggested that aromatherapy can be
tried before conventional techniques in managing nausea and vomiting and used alongside it in
a complementary manner.
This quasi experimental mixed method study will utilize a convenience sample and a pre- and
post-study design study to determine the feasibility of implementing an aromatherapy
intervention on two acute care units.
Primary outcomes for this study include anxiety, nausea, perception of caring and well-being.
In addition, an open-ended qualitative inquiry will be used to further explore the experience
including potential positive and negative outcomes.
This study will be conducted on two acute care inpatient care areas: labor delivery unit with
healthy pregnant women and on a general adult surgical unit with persons having elective
surgery. Twenty patients will be recruited from the surgical unit and thirty from the
obstetrical unit.
Study Procedure Using inclusion/exclusion outlined criteria below, all patients meeting
inclusion criteria will be introduced to the aromatherapy intervention by the nurse research
assistant who is caring for them. Potential participants will be asked if they wish to enroll
in the study during their hospitalization. If they express interest, patients will be given
information regarding the investigation and the informed consent form to read. The Principal
Investigator (PI) will be notified. The nurse research assistant will answer any questions of
the potential participant and if the patient agrees to enroll in the study, the nurse
research assistant will obtain a written informed consent. Once enrolled, demographic
variables will be collected and the following measures will be obtained before the
aromatherapy intervention and immediately after the intervention.
1. Vital signs including blood pressure, pulse and level of respirations
2. Generalized Anxiety Disorder (GAD-7) scale
3. Visual Analog Scale (VAS) for nausea
4. Watson Caritas Patient Score
5. Warwick-Edinburgh mental well-being scale (WEMWBS)
The day after the inhaled essential oil is administered, a different member of the study team
will ask the patient open-ended questions about their experience with aromatherapy.
Aromatherapy intervention
- Lavender inhaled essential oil will be used for perceived caring, wellbeing and reported
anxiety in all patients
- Ginger essential oil will be used for patients who report nausea.
- A certified study clinician will administer the inhaled essential oil during labor or
during the postoperative recovery period.
Patients on the labor and delivery inpatient unit (Blake 14) and post-operative surgical
inpatient unit (Ellison 7) will be offered aromatherapy as an alternative treatment for
nausea and anxiety in labor and during the post-operative surgical recovery period.
Aromatherapy is an integrative, nonpharmacological intervention that will be explored as a
treatment of nausea, vomiting, anxiety, and comfort in labor and post-operative surgical
recovery.
On admission, the patient will be asked to list their allergies. If the patient has allergies
to study aromatherapy oils, then the patient will be excluded from the study. If the patient
appears to develop an allergic reaction or any other adverse reaction to an administered
essential oil, the use of aromatherapy in this patient will be discontinued immediately and
the patient will be removed from the study.
All patients on Labor & Delivery and on Ellison 7 will be asked if they wish to participate
in this investigation. Patients must be at least 18 years of age and able to provide informed
consent.
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