Plain English Summary
Background and study aims
Anxiety while pregnant is associated with poorer outcomes for both the mother and the fetus. We are carrying out a study to assess the immediate and long-term effects of attending sessions of antenatal yoga on subjective and physiological measures of anxiety. This study will answer the following questions: Do women who attend yoga while pregnant show less anxiety than women who receive standard care? What effect does a single session of yoga have on self-reported anxiety symptoms and stress hormone levels? Is any single-session effect consistent after repeated sessions?
Who can participate?
Eligible pregnant women must be over 18 years old with their first pregnancy lasting beyond 13 weeks.
What does the study involve?
Participants are randomly allocated to either the yoga group or the control group. The yoga group women will attend our yoga programme. The control group women are asked not to attend our yoga sessions during their pregnancy (but may attend other yoga classes). Regardless of which group participants are placed in, we would like them to complete a postal questionnaire at baseline and once the yoga group have completed the 8-week course of yoga. Participants allocated to the yoga group will be asked to complete a brief questionnaire and to provide a saliva sample both before and after the class at the first and final sessions of the 8-week programme. This will allow us to measure your level of the stress hormone cortisol and subjective reports of anxiety.
What are the possible benefits and risks of participating?
If allocated to the yoga group, participants will benefit from free yoga sessions. Participants in the control group will be given the opportunity to answer questions on how they feel about their pregnancy. In the initial small study, many reported this opportunity to describe their pregnancy anonymously as therapeutic. There will be no physical risk in taking part in the study. Chewing on the cotton bud to provide the saliva sample may taste peculiar, but will not cause any physical harm or discomfort. Participants do not have to answer any questions in the questionnaire packs which they find difficult to answer.
Where is the study run from?
This study has been set up by the University of Manchester, UK.
When is the study starting and how long is it expected to run for?
Recruitment for this study started at the end of 2010 and recruitment was completed in May 2011.
Who is funding the study?
Funding has been provided by Tommy's, the baby charity.
Who is the main contact?
Dr James Newham
james.newham@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr James J Newham
ORCID ID
Contact details
5th Floor (Research)
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
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james.newham@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8992
Study information
Scientific title
Can Antenatal yoga Lower Maternal Anxiety (CALMA): a randomised controlled trial
Acronym
CALMA
Study hypothesis
Pregnant women in the second or third trimester will be approached by midwives or sonographers regarding whether they would be interested in taking part in a randomised controlled trial. Those who consent to take part will be randomised to either an 8-week course of antenatal yoga or treatment as usual. Participants in both groups will complete questionnaires assessing mood both before and after the intervention period to determine whether antenatal yoga has within-group reductions in maternal anxiety that significantly differ from those who receive standard care.
More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=8992
Ethics approval
North West 9 Research Ethics Committee - Greater Manchester West,14/07/2010, ref: 10/H1014/43
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Mental Health Research Network, Reproductive Health and Childbirth; Subtopic: Anxiety, Reproductive Health and Childbirth (all Subtopics); Disease: Anxiety, General Obstetrics/Midwifery
Intervention
Treatment-as-usual
Standard care; Yoga, 8-week relaxation-based intervention
Follow-Up Length: 2 months
Study Entry : Single Randomisation only
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Wijma Delivery Expectancy Questionnaire; Timepoint(s): pre and post intervention
Secondary outcome measures
1. Edinburgh Postnatal Depression Scale; Timepoint(s): pre and post intervention
2. State trait Anxiety Inventory; Timepoint(s): pre and post intervention
Overall trial start date
01/12/2010
Overall trial end date
27/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pregnant women between 18-40 years of age
2. With their first pregnancy lasting beyond 13 weeks, in the first 6 months of pregnancy (<26 weeks gestation)
3. Who can speak and understand English fluently
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 72; UK Sample Size: 72; Description: Randomised to Intervention = 36Randomised to Control = 36
Participant exclusion criteria
1. Participants will be excluded if they are on any prescription medication other than pregnancy supplements
2. Are expecting multiple pregnancies (e.g. twins)
3. Are already attending antenatal yoga classes
4. Expecting a child with any abnormality
5. Are surrogate mothers or are planning to put their child up for adoption
6. Have pre-existing diabetes or have any heart or kidney disease. After consulting yoga instructors (who allowed us to recruit from their yoga classes in the pilot study we ran), no exclusion criteria for attending antenatal yoga was stipulated
Recruitment start date
01/12/2010
Recruitment end date
27/05/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St. Mary's Hospital
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Guild Lodge
Whittingham
Manchester
M13 9PL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Manchester Statistical Society (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Tommy's (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24788589