Effects of Aromatherapy on Childbirth
Primary Purpose
Parturition, Natural Childbirth, Labor Pain
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Aromatherapy oil
None essential oil
Sponsored by
About this trial
This is an interventional health services research trial for Parturition focused on measuring aromatherapy, childbirth, Obstetrics, Labour, Complementary Medicine, delivery, obstetric
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.
Sites / Locations
- Kings Mill HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Aromatherapy group 1
Control group 2
Control group 3
Arm Description
Participants will be given essential oil consisting of (Peppermint, Lavender, Clary Sage and Frankincense) together with a swab to put the oil on.
Participants receive a bottle of non essential oil and a swab.
Standard maternity care to measure baseline.
Outcomes
Primary Outcome Measures
Whether aromatherapy can lower levels of anxiety in women in labour
Secondary Outcome Measures
Whether aromatherapy decreases analgesia use in women in labour
Whether aromatherapy increases her perceived quality and satisfaction of women in labour
Full Information
NCT ID
NCT01051726
First Posted
January 15, 2010
Last Updated
January 15, 2013
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT01051726
Brief Title
Effects of Aromatherapy on Childbirth
Official Title
Effects of Aromatherapy on Childbirth
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Aromatherapy oils (e.g. clary sage, peppermint, lavender, frankincense)
Non-essential oil (baby oil)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parturition, Natural Childbirth, Labor Pain
Keywords
aromatherapy, childbirth, Obstetrics, Labour, Complementary Medicine, delivery, obstetric
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aromatherapy group 1
Arm Type
Experimental
Arm Description
Participants will be given essential oil consisting of (Peppermint, Lavender, Clary Sage and Frankincense) together with a swab to put the oil on.
Arm Title
Control group 2
Arm Type
Placebo Comparator
Arm Description
Participants receive a bottle of non essential oil and a swab.
Arm Title
Control group 3
Arm Type
No Intervention
Arm Description
Standard maternity care to measure baseline.
Intervention Type
Other
Intervention Name(s)
Aromatherapy oil
Intervention Description
Oil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil.
Intervention Type
Other
Intervention Name(s)
None essential oil
Intervention Description
Baby oil
Primary Outcome Measure Information:
Title
Whether aromatherapy can lower levels of anxiety in women in labour
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Whether aromatherapy decreases analgesia use in women in labour
Time Frame
1 year
Title
Whether aromatherapy increases her perceived quality and satisfaction of women in labour
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn-Marie Walker, BSc MSc PhD
Phone
+44 (0)115 82 30511
Email
dawn-marie.walker@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn-Marie Walker, BSc MSc PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings Mill Hospital
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dr.dawn marie walker, msc phd
Phone
01158230511
Email
dawn-marie.walker@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
dr.kahkashan noor, mbbs
Phone
01158230457
Email
mcxkn@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
dr.dawn marie walker, msc phd
12. IPD Sharing Statement
Learn more about this trial
Effects of Aromatherapy on Childbirth
We'll reach out to this number within 24 hrs