Effects of Aromatherapy on Childbirth

Sponsor
University of Nottingham (Other)
Overall Status
Unknown status
CT.gov ID
NCT01051726
Collaborator
(none)
90
1
3
18
5

Study Details

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
  • Other: Aromatherapy oil
  • Other: None essential oil
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2012
Anticipated Primary Completion Date :
Jul 1, 2013
Anticipated Study Completion Date :
Jul 1, 2013

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 [1 year]

Secondary Outcome Measures

  1. Whether aromatherapy decreases analgesia use in women in labour [1 year]

  2. Whether aromatherapy increases her perceived quality and satisfaction of women in labour [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Kings Mill Hospital Nottingham United Kingdom

Sponsors and Collaborators

  • University of Nottingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01051726
Other Study ID Numbers:
  • 10018
First Posted:
Jan 18, 2010
Last Update Posted:
Jan 16, 2013
Last Verified:
Jan 1, 2013
Keywords provided by University of Nottingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 16, 2013