Text Size
Trial record 3 of 5 for:    Open Studies | "Delivery, Obstetric"
Previous Study | Return to List | Next Study

Effects of Aromatherapy on Childbirth

This study is currently recruiting participants.
Verified January 2013 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01051726
First received: January 15, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Parturition
Natural Childbirth
Labor Pain
 Other: Aromatherapy oil
Other: None essential oil
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
Official Title: Effects of Aromatherapy on Childbirth

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Whether aromatherapy can lower levels of anxiety in women in labour [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Whether aromatherapy decreases analgesia use in women in labour [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Whether aromatherapy increases her perceived quality and satisfaction of women in labour [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01051726     History of Changes
Other Study ID Numbers: 10018
Study First Received: January 15, 2010
Last Updated: January 15, 2013
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on May 19, 2013