ParturitionPhase 2NCT01051726
Effects of Aromatherapy on Childbirth
A Phase 2 study testing Aromatherapy oil and None essential oil in people with Parturition and Natural Childbirth, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parturition, Natural Childbirth, Labor Pain
- What is being tested?
- Aromatherapy oil and None essential oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- preterm labour;
- pool births;
- scheduled caesarean section.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Kings Mill Hospital
Nottingham
dr.dawn marie walker, msc phd, 01158230511, dawn-marie.walker@nottingham.ac.uk
dr.kahkashan noor, mbbs, 01158230457, mcxkn@nottingham.ac.uk
About this study
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
Read more
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
- Conditions
- Parturition, Natural Childbirth, Labor Pain
- Being tested
- Aromatherapy oil, None essential oil
- Keywords
- aromatherapy, childbirth, Obstetrics, Labour, Complementary Medicine, delivery, obstetric
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy oilOther
Oil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil.
None essential oilOther
Baby oil
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy group 1 | Experimental | Participants will be given essential oil consisting of (Peppermint, Lavender, Clary Sage and Frankincense) together with a swab to put the oil on. Receives: Other: Aromatherapy oil |
| Control group 2 | Placebo comparator | Participants receive a bottle of non essential oil and a swab. Receives: Other: None essential oil |
| Control group 3 | No intervention | Standard maternity care to measure baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether aromatherapy can lower levels of anxiety in women in labour
Measured: 1 year
Secondary outcomes (2)
Whether aromatherapy decreases analgesia use in women in labour
Measured: 1 year
Whether aromatherapy increases her perceived quality and satisfaction of women in labour
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startJan 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturitionStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn-Marie Walker, BSc MSc PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051726
- Sponsor's protocol ID
- 10018
- Status last verified
- Jan 2013
- First submitted
- 15 Jan 2010
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aromatherapy on Childbirth
- ClinicalTrials.gov ID
- NCT01051726
- Acronym / sponsor ID
- 10018
- Conditions
- Parturition, Natural Childbirth, Labor Pain
- Keywords
- aromatherapy, childbirth, Obstetrics, Labour, Complementary Medicine, delivery, obstetric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy group 1 | Experimental | Other: Aromatherapy oilParticipants will be given essential oil consisting of (Peppermint, Lavender, Clary Sage and Frankincense) together with a swab to put the oil on. |
| Control group 2 | Placebo comparator | Other: None essential oilParticipants receive a bottle of non essential oil and a swab. |
| Control group 3 | No intervention | –Standard maternity care to measure baseline. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- preterm labour;
- pool births;
- scheduled caesarean section.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy oilOil consists of Clary Sage, Peppermint, Lavender and Frankincense with drops of each mixed into a carrier oil. | Other | Aromatherapy group 1 |
| None essential oilBaby oil | Other | Control group 2 |
Primary outcome
Whether aromatherapy can lower levels of anxiety in women in labour
Time frame: 1 year
2 secondary outcomes
Whether aromatherapy decreases analgesia use in women in labour
Time frame: 1 year
Whether aromatherapy increases her perceived quality and satisfaction of women in labour
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn-Marie Walker, BSc MSc PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aromatherapy oil and None essential oil in people with Parturition and Natural Childbirth, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dawn-Marie Walker, BSc MSc PhD (+44 (0)115 82 30511, dawn-marie.walker@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether aromatherapy can lower levels of anxiety in women in labour (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.