Clinical trial NCT01051726: Effects of Aromatherapy on Childbirth
Official title: Effects of Aromatherapy on Childbirth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parturition
Natural Childbirth
Labor Pain
Keywords: aromatherapy
childbirth
Obstetrics
Labour
Complementary Medicine
delivery, obstetric
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility 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.

Primary outcomes:
measure: Whether aromatherapy can lower levels of anxiety in women in labour
timeFrame: 1 year
Secondary outcomes:
measure: Whether aromatherapy decreases analgesia use in women in labour
timeFrame: 1 year
measure: Whether aromatherapy increases her perceived quality and satisfaction of women in labour
timeFrame: 1 year
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Kings Mill Hospital
Study officials:
affiliation: University of Nottingham
name: Dawn-Marie Walker, BSc MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: