ISRCTN ISRCTN47224604
DOI https://doi.org/10.1186/ISRCTN47224604
Secondary identifying numbers 8992
Submission date
10/09/2013
Registration date
10/09/2013
Last edited
27/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr James J Newham
Scientific

5th Floor (Research)
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Email james.newham@ncl.ac.uk

Study information

Study designRandomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCan Antenatal yoga Lower Maternal Anxiety (CALMA): a randomised controlled trial
Study acronymCALMA
Study objectivesPregnant 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(s)North West 9 Research Ethics Committee - Greater Manchester West,14/07/2010, ref: 10/H1014/43
Health condition(s) or problem(s) studiedTopic: Mental Health Research Network, Reproductive Health and Childbirth; Subtopic: Anxiety, Reproductive Health and Childbirth (all Subtopics); Disease: Anxiety, General Obstetrics/Midwifery
InterventionTreatment-as-usual

Standard care; Yoga, 8-week relaxation-based intervention

Follow-Up Length: 2 months

Study Entry : Single Randomisation only
Intervention typeBehavioural
Primary outcome measureWijma Delivery Expectancy Questionnaire; Timepoint(s): pre and post intervention
Secondary outcome measures1. Edinburgh Postnatal Depression Scale; Timepoint(s): pre and post intervention
2. State trait Anxiety Inventory; Timepoint(s): pre and post intervention
Overall study start date01/12/2010
Completion date27/05/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit40 Years
SexFemale
Target number of participantsPlanned Sample Size: 72; UK Sample Size: 72; Description: Randomised to Intervention = 36Randomised to Control = 36
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2010
Date of final enrolment27/05/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St. Mary's Hospital
Manchester
M13 9WL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Guild Lodge
Whittingham
Manchester
M13 9PL
England
United Kingdom

Website http://www.manchester.ac.uk/
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Charity

Manchester Statistical Society (UK)

No information available

Tommy's (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2014 Yes No