Effects of Aromatherapy on Childbirth

Labor Pain Clinical Trial

Official title:

Effects of Aromatherapy on Childbirth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01051726
• Other study ID #: 10018
• Status: Recruiting
• Phase: Phase 2
• First received: January 15, 2010
• Last updated: January 15, 2013
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: January 2013
• Source: University of Nottingham
• Contact: Dawn-Marie Walker, BSc MSc PhD
• Phone: +44 (0)115 82 30511
• Email: dawn-marie.walker[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Labor Pain
• Natural Childbirth
• Parturition

Intervention

Other:
• Aromatherapy oil
Oil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil.
• None essential oil
Baby oil

Locations

Country	Name	City	State
United Kingdom	Kings Mill Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether aromatherapy can lower levels of anxiety in women in labour		1 year	No
Secondary	Whether aromatherapy decreases analgesia use in women in labour		1 year	No
Secondary	Whether aromatherapy increases her perceived quality and satisfaction of women in labour		1 year	No