Mother and Baby Yoga Study - Early Postnatal Yoga and Mental Health

Anxiety Clinical Trial

— MABY  

Official title:

Mother and Baby Yoga Study - Investigating the Influence of an Early Postnatal Mother and Baby Yoga Programme on Maternal Mental Health and Relationship With Baby: a Randomised Feasibility Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056609
• Other study ID #: 294028YNP
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: York Teaching Hospitals NHS Foundation Trust
• Contact: Deborah Phillips
• Phone: 07464491875
• Email: deborah.phillips23[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigating the influence of an early postnatal mother and baby yoga programme on maternal mental health and relationship with baby: a randomised feasibility study.

It is thought postnatal mother and baby yoga decreases levels of depression and anxiety and increases subjective experience of maternal-infant bonding. This project will provide the necessary data to determine whether a regular programme would be beneficial to mothers.

The research study is an eight-week online programme incorporating gentle postnatal mother and baby yoga involving women 6-12 weeks following birth (at recruitment/study commencement). The outcome measures include mothers' feelings about their mental health and bond with their baby.

Description:

The intended research is an eight-week online programme incorporating gentle postnatal mother and baby yoga.The project will provide essential pilot data to help determine whether mother and baby yoga would be beneficial if offered as a regular service. To achieve this aim, the following study objectives will be addressed:

1. Identify possible links between participation a in programme of mother and baby yoga and maternal subjective experience with mental health

2. Verify whether mother and baby yoga can influence mothers feelings about the bond with their baby

3. Request feedback from the participants to examine the feasibility of running a similar larger study

The outcome measures include mental health and feelings about bonding. The project will provide essential pilot data to help determine whether parent and baby yoga would be acceptable and beneficial if offered as a regular service. Pregnant women and new mothers have suffered negative mental health impacts of COVID-19. An online course has been designed to mitigate anxieties associated with the pandemic, enabling women to follow the course in their own time within a safe environment.

The mental health of women during and after pregnancy is of major concern to health professionals, families and society. 20% of women develop mental health problems during pregnancy or within a year of giving birth. Mental health is the third largest cause of direct maternal deaths during or within 42 days of pregnancy. Suicide is the leading cause of maternal death within a year of giving birth.

Perinatal mental health problems in the UK cost £8.1 billion per year. The average cost to society of one case of perinatal depression is around £74,000, of which £23,000 relates to the mother and £51,000 relates to the impacts on the child. The cost of mental health to the public sector is five times more than the cost of improving mental health services.

Improving outcomes for women will minimise the negative effects on the infant. NICE add that a woman's ability to provide nurturing depends on her own emotional well-being. The charity Best Beginnings believes that all children regardless of income or background should have the best possible start in life, laying foundations for better future life chances. UNICEF Baby Friendly initiative encourages frequent touch and sensitive communication as this trigger's oxytocin, which facilities babies brain development.

Postnatal mum and baby yoga are two distinct areas of therapy, but work well when practiced together. Current evidence supporting yoga in the perinatal period is limited and mostly focuses on pregnancy. Sheffield and Woods-Giscombé call for more larger studies to validate and extend existing findings that demonstrate the potential of yoga for improving mental health for women and infants.

A systematic review concluded Yoga-based interventions may offer a promising potential intervention for maternal mental health and well-being. However, due to the limited number of studies, and a lack of consistency in study design and measures, more high-quality research is required to establish these effects, assess potential benefits on other aspects of maternal well-being and explore potential benefits for outcomes relating to the infant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18 and above

• 6-12 weeks post birth or 11-12 weeks if birthed by caesarean section

• Uncomplicated postnatal recovery for mother and infant

• Attended postnatal check with and supported to take part in the study by their GP.

• Understand written and/or spoken English

Exclusion Criteria:

• Age 18 and above

• Under 6 weeks post birth or over 12 weeks post birth

• Under 11 weeks or over 12 weeks if birthed by caesarean

• Not attended postnatal check with GP

• Uncontrolled or new medical condition that will increase the risk of unsupervised exercise (cardiac, musculoskeletal, neurological)

• Recent surgical intervention and still in the recovery period

• Uncontrolled or new treatment for depression and/or anxiety

• Currently recovering from a pregnancy or birth related problem that requires health practitioner follow up (medical, surgical, mental health)

• Neonatal complications (prematurity, birth complications, medical/surgical problems, genetic disorders)

• Drug or alcohol dependency

• Multiple birth

• Unable to understand written and/or spoken English

Related Conditions & MeSH terms

• Anxiety
• Depression, Postpartum
• Mental Health Issue

Intervention

Other:
• Yoga
An 8 week online mother and baby yoga programme to include daily diary completion and questionnaires at designated study timepoints

Locations

Country	Name	City	State
United Kingdom	York & Scarborough Teaching Hospitals NHS Foundation Trust	York	N. Yorks

Sponsors (2)

Lead Sponsor	Collaborator
York Teaching Hospitals NHS Foundation Trust	University of York

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4. — View Citation

Cox JL, Chapman G, Murray D, Jones P. Validation of the Edinburgh Postnatal Depression Scale (EPDS) in non-postnatal women. J Affect Disord. 1996 Jul 29;39(3):185-9. doi: 10.1016/0165-0327(96)00008-0. — View Citation

Doran F, Hornibrook J. Women's experiences of participation in a pregnancy and postnatal group incorporating yoga and facilitated group discussion: a qualitative evaluation. Women Birth. 2013 Mar;26(1):82-6. doi: 10.1016/j.wombi.2012.06.001. Epub 2012 Jul 19. — View Citation

Durankus F, Aksu E. Effects of the COVID-19 pandemic on anxiety and depressive symptoms in pregnant women: a preliminary study. J Matern Fetal Neonatal Med. 2022 Jan;35(2):205-211. doi: 10.1080/14767058.2020.1763946. Epub 2020 May 18. — View Citation

Fallon V, Halford JCG, Bennett KM, Harrold JA. The Postpartum Specific Anxiety Scale: development and preliminary validation. Arch Womens Ment Health. 2016 Dec;19(6):1079-1090. doi: 10.1007/s00737-016-0658-9. Epub 2016 Aug 29. — View Citation

Jiang Q, Wu Z, Zhou L, Dunlop J, Chen P. Effects of yoga intervention during pregnancy: a review for current status. Am J Perinatol. 2015 May;32(6):503-14. doi: 10.1055/s-0034-1396701. Epub 2014 Dec 23. — View Citation

MacDonald C. Mother and baby yoga is good for you. Pract Midwife. 2013 May;16(5):14, 16, 18. — View Citation

Sheffield KM, Woods-Giscombe CL. Efficacy, Feasibility, and Acceptability of Perinatal Yoga on Women's Mental Health and Well-Being: A Systematic Literature Review. J Holist Nurs. 2016 Mar;34(1):64-79. doi: 10.1177/0898010115577976. Epub 2015 Apr 20. — View Citation

Timlin D, Simpson EE. A preliminary randomised control trial of the effects of Dru yoga on psychological well-being in Northern Irish first time mothers. Midwifery. 2017 Mar;46:29-36. doi: 10.1016/j.midw.2017.01.005. Epub 2017 Jan 13. — View Citation

Vogel L. Tailored treatment for postpartum depression. CMAJ. 2011 Nov 8;183(16):E1163-4. doi: 10.1503/cmaj.109-4003. Epub 2011 Oct 3. No abstract available. — View Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal subjective experience of their mental health during and post online yoga programme	This is an explorative feasibility study which will expand current knowledge on the link between participation in a mother and baby yoga program & maternal subjective experience with mental health. Mental health related outcomes are measured using the Edinburgh Postnatal Scale (scores of 10 or more are suggestive of depression requiring further evaluation). Using well-established scales allows for comparison with other studies. A short two weekly questionnaire is sent to all participants for the duration of the study. Many studies have found the Positive Affect Negative Affect Scale (scores range from 10 - 50 on both scales with higher scores on the positive affect scale representing higher levels of positive affect, and lower scores on the negative affect scale representing lower levels of negative affect) to be a reliable and valid tool.	8 weeks
Primary	Maternal subjective experience of their mental health during and post online yoga	This is an explorative feasibility study which will expand current knowledge on the link between participation in a mother and baby yoga program & maternal subjective experience with mental health. Mental health related outcomes are measured using the Postpartum Specific Anxiety Scale (a score of >112 requires further evaluation). Using well-established scales allows for comparison with other studies. A short two weekly questionnaire is sent to all participants for the duration of the study. Many studies have found the Positive Affect Negative Affect Scale (scores range from 10 - 50 on both scales with higher scores on the positive affect scale representing higher levels of positive affect, and lower scores on the negative affect scale representing lower levels of negative affect) to be a reliable and valid tool.	8 weeks
Secondary	Maternal subjective feelings and experience towards the body and bond with infant post partum, during and post online yoga programme	Secondary outcome measures include feelings towards the body and mother's bond with infant. Feelings toward the body will be measured by the Postpartum Mind and Body scale (PMB). The PMB is 41-item scale with responses made on a 5-point likert scale (ranging from strongly agree to strongly disagree). Body satisfaction is important during the perinatal period in predicting outcomes such as depression and anxiety. Body satisfaction has also been found to relate to antenatal attachment in pregnant samples. Mother and infant bonding will be measured with the Postpartum Bonding Questionnaire. The PBQ is a 25-item measure of parent infant bonding. Responses are made on a 6-point Likert scale ranging from 0 - 5 (0 = always, 5 = never). The scale consists of four subscales: 1) weakened bonding, 2) rejection and pathological rage, 3) anxiety about the baby/anxiety about caring for the baby, and 4) risk of abuse to the baby (the subscale examining risk of abuse will be omitted from this study).	8 weeks

External Links

•   Knight M, Bunch K, Tuffnell D, Jayakody H, Shakespeare J, Kotnis R et al. Saving Lives, Improving Mothers' Care: Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2014-16
•   London: Best Beginnings [updated 2020 August 06, cited 2020 August 06];
•   National Institute for Health and Care Excellence (NICE). Postnatal care. Quality standard (QS37). London: NICE. [updated: 01 2015 June, cited 2020 August];
•   NHS England, Improvement NHS, for Mental Health NCC, Others. Implementing the Mental Health Forward View. London: NHS England [Internet] 2017
•   Preston, C. & Kirk, E (2020 December 16th). Postnatal Mind and Body. [Webinar Presentation]. Becoming Mothers: Perinatal Mind and Body Research - Postnatal Bodies. University of York UK
•   Royal College of Psychiatrists. COVID-19: Mental health before, during and after pregnancy [Internet]. London: Royal College of Psychiatrists [updated 2020 August 01, cited 2020 August 06]
•   The Baby Friendly Initiative. Building a Happy Baby A Guide for Parents [Internet]; London: UNICEF UK [updated 2019 March, cited 2020 August].