Effects of Aromatherapy on Childbirth

NCT ID: NCT01051726

Last Updated: 2013-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Parturition Natural Childbirth Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Aromatherapy oil

Intervention Type OTHER

Oil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil.

Control group 2

Participants receive a bottle of non essential oil and a swab.

Group Type PLACEBO_COMPARATOR

None essential oil

Intervention Type OTHER

Baby oil

Control group 3

Standard maternity care to measure baseline.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aromatherapy oil

Oil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil.

Intervention Type OTHER

None essential oil

Baby oil

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dawn-Marie Walker, BSc MSc PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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Kings Mill Hospital

Nottingham, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dawn-Marie Walker, BSc MSc PhD

Role: CONTACT

+44 (0)115 82 30511

Facility Contacts

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dr.dawn marie walker, msc phd

Role: primary

01158230511

dr.kahkashan noor, mbbs

Role: backup

01158230457

Other Identifiers

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10018

Identifier Type: -

Identifier Source: org_study_id

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