NCT04457947

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

March 6, 2020

Last Update Submit

July 8, 2020

Conditions

Keywords

aromatherapylavendarginger

Outcome Measures

Primary Outcomes (2)

  • 1. To understand the impact of aromatherapy on wellbeing as measured by the Warwick-Edinburgh mental well-being scale .

    Measures well-being, 14 items with a 5 point likert scale, 1=none of the time and 5=all of the time

    through study completion, an average six months

  • 2. To understand the impact of aromatherapy on perception of caring as measured by the Watson Caritas Patient Score

    Assess patient perspective on compassionate care with a 7 point likert scale, 1= never, 7= always

    through study completion, an average six months

Other Outcomes (3)

  • 3. To understand the impact of aromatherapy on anxiety as measured by Generalized Anxiety Disorder (GAD-7) scale

    through study completion, an average six months

  • 4. To understand the impact of aromatherapy on nausea as measured by VAS for nausea.

    through study completion, an average six months

  • 1. To qualitatively explore the overall experience of patients who have had an aromatherapy intervention

    through study completion, an average six months

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 mothers in labor 20 patients who have undergone surgical operation

You may qualify if:

  • Inpatient Blake 14 and Ellison 7
  • Able to give consent

You may not qualify if:

  • \. Patients who have allergies or sensitivities to essential oils, lavender and ginger 2. Patients with bleeding or clotting disorder 3. Patients who are unable to give informed consent 4. Patients who are younger than 18 years old 5. Patients who are unable to read or write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Brewer BB, Watson J. Evaluation of Authentic Human Caring Professional Practices. J Nurs Adm. 2015 Dec;45(12):622-7. doi: 10.1097/NNA.0000000000000275.

  • Rashidi-Fakari F, Tabatabaeichehr M, Mortazavi H. The effect of aromatherapy by essential oil of orange on anxiety during labor: A randomized clinical trial. Iran J Nurs Midwifery Res. 2015 Nov-Dec;20(6):661-4. doi: 10.4103/1735-9066.170001.

  • Buckle J. Literature review: should nursing take aromatherapy more seriously? Br J Nurs. 2007 Jan 25-Feb 7;16(2):116-20. doi: 10.12968/bjon.2007.16.2.22772.

  • Burns EE, Blamey C, Ersser SJ, Barnetson L, Lloyd AJ. An investigation into the use of aromatherapy in intrapartum midwifery practice. J Altern Complement Med. 2000 Apr;6(2):141-7. doi: 10.1089/acm.2000.6.141.

  • Eisenberg DM, Kaptchuk TJ, Post DE, Hrbek AL, O'Connor BB, Osypiuk K, Wayne PM, Buring JE, Levy DB. Establishing an Integrative Medicine Program Within an Academic Health Center: Essential Considerations. Acad Med. 2016 Sep;91(9):1223-30. doi: 10.1097/ACM.0000000000001173.

Study Officials

  • Amanda B Coakley, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda B. Coakley, PhD

CONTACT

Michelle O'Hara, DNP

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 6, 2020

First Posted

July 7, 2020

Study Start

September 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

July 10, 2020

Record last verified: 2020-07