NCT01051726

Brief Summary

Aromatherapy is a form of complementary medicine that uses scented materials known as essential oils for the purpose of affecting a person's health or mood. Although aromatherapy has been used in childbirth for centuries, there are no high-quality studies examining whether the treatment works. Methodology We would like to see if aromatherapy affects a woman's experience of childbirth by lowering associated anxiety and pain. Consenting participants will be randomly allocated to one of these groups:

  1. 1.Aromatherapy oils (e.g. clary sage, peppermint, lavender, frankincense)
  2. 2.Non-essential oil (baby oil)
  3. 3.Standard maternity care

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

January 15, 2010

Last Update Submit

January 15, 2013

Conditions

ParturitionNatural ChildbirthLabor Pain

Keywords

aromatherapychildbirthObstetricsLabourComplementary Medicinedelivery, obstetric

Outcome Measures

Primary Outcomes (1)

  • Whether aromatherapy can lower levels of anxiety in women in labour

    1 year

Secondary Outcomes (2)

  • Whether aromatherapy decreases analgesia use in women in labour

    1 year

  • Whether aromatherapy increases her perceived quality and satisfaction of women in labour

    1 year

Study Arms (3)

Aromatherapy group 1

EXPERIMENTAL

Participants will be given essential oil consisting of (Peppermint, Lavender, Clary Sage and Frankincense) together with a swab to put the oil on.

Other: Aromatherapy oil

Control group 2

PLACEBO COMPARATOR

Participants receive a bottle of non essential oil and a swab.

Other: None essential oil

Control group 3

NO INTERVENTION

Standard maternity care to measure baseline.

Interventions

Aromatherapy oilOTHER

Oil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil.

Aromatherapy group 1
None essential oilOTHER

Baby oil

Control group 2

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • women in labour and expecting a normal delivery,
  • aged \> 16 who are able to make informed consent;
  • singleton pregnancy;
  • spontaneous or induced labour onset;
  • prior to elective or emergency caesarean section.

You may not qualify if:

  • preterm labour;
  • pool births;
  • scheduled caesarean section.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kings Mill Hospital

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dawn-Marie Walker, BSc MSc PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn-Marie Walker, BSc MSc PhD

CONTACT

+44 (0)115 82 30511dawn-marie.walker@nottingham.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

January 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

GB(1)