Effects of Aromatherapy on Childbirth

January 15, 2013 updated by: University of Nottingham

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

We will gather primary data, e.g. if she's been in labour before and her awareness of complementary medicine. We will also conduct the Spielberger State-Trait Anxiety Inventory with her, and provide her with the oil and swab if she is in groups 1 or 2 with instructions to keep the swab with the oil on it near to her. She can also put more oil on the swab as she requires.

Postnatally, data will be collected from her notes regarding pain relief used, duration of labour, augmentation of labour, and any other medical interventions of note. We will also complete the anxiety scale with her once more. Before her discharge we ask the mother for any comments regarding her experience of the labour. The results from all three cohorts will then be compared. There will also be opportunity for the midwife to make any comments regarding his/her perception of the participant's labour. Finally we will hold a focus group with midwives regarding the practicalities for implementation of aromatherapy in maternity care

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aromatherapy group 1
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
Oil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil.
Placebo Comparator: Control group 2
Participants receive a bottle of non essential oil and a swab.
Other: None essential oil
Baby oil
No Intervention: Control group 3
Standard maternity care to measure baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whether aromatherapy can lower levels of anxiety in women in labour
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Whether aromatherapy decreases analgesia use in women in labour
Time Frame: 1 year
1 year
Whether aromatherapy increases her perceived quality and satisfaction of women in labour
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Dawn-Marie Walker, BSc MSc PhD, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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