We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Aromatherapy on Childbirth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01051726
Recruitment Status : Unknown
Verified January 2013 by University of Nottingham.
Recruitment status was:  Recruiting
First Posted : January 18, 2010
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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. 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


Condition or disease Intervention/treatment Phase
Parturition Natural Childbirth Labor Pain Other: Aromatherapy oil Other: None essential oil Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Effects of Aromatherapy on Childbirth
Study Start Date : January 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Childbirth
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Whether aromatherapy can lower levels of anxiety in women in labour [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Whether aromatherapy decreases analgesia use in women in labour [ Time Frame: 1 year ]
  2. Whether aromatherapy increases her perceived quality and satisfaction of women in labour [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051726


Contacts
Contact: Dawn-Marie Walker, BSc MSc PhD +44 (0)115 82 30511 dawn-marie.walker@nottingham.ac.uk

Locations
United Kingdom
Kings Mill Hospital Recruiting
Nottingham, United Kingdom
Contact: dr.dawn marie walker, msc phd    01158230511    dawn-marie.walker@nottingham.ac.uk   
Contact: dr.kahkashan noor, mbbs    01158230457    mcxkn@nottingham.ac.uk   
Principal Investigator: dr.dawn marie walker, msc phd         
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Dawn-Marie Walker, BSc MSc PhD University of Nottingham
More Information

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01051726     History of Changes
Other Study ID Numbers: 10018
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by University of Nottingham:
aromatherapy
childbirth
Obstetrics
Labour
Complementary Medicine
delivery, obstetric

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms