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Effects of Aromatherapy on Childbirth

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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):
University of Nottingham

Tracking Information
First Submitted Date  ICMJE January 15, 2010
First Posted Date  ICMJE January 18, 2010
Last Update Posted Date January 16, 2013
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
Whether aromatherapy can lower levels of anxiety in women in labour [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
  • Whether aromatherapy decreases analgesia use in women in labour [ Time Frame: 1 year ]
  • Whether aromatherapy increases her perceived quality and satisfaction of women in labour [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Aromatherapy on Childbirth
Official Title  ICMJE Effects of Aromatherapy on Childbirth
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Parturition
  • Natural Childbirth
  • Labor Pain
Intervention  ICMJE
  • Other: Aromatherapy oil
    Oil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil.
  • Other: None essential oil
    Baby oil
Study Arms  ICMJE
  • 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.
    Intervention: Other: Aromatherapy oil
  • Placebo Comparator: Control group 2
    Participants receive a bottle of non essential oil and a swab.
    Intervention: Other: None essential oil
  • No Intervention: Control group 3
    Standard maternity care to measure baseline.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 15, 2010)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01051726
Other Study ID Numbers  ICMJE 10018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dawn-Marie Walker, BSc MSc PhD University of Nottingham
PRS Account University of Nottingham
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP