Clinical trial NCT06056609: Mother and Baby Yoga Study - Early Postnatal Yoga and Mental Health
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Depression, Postpartum
Anxiety
Lead sponsor: York Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of York
First posted: 2023-09-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal subjective experience of their mental health during and post online yoga programme
timeFrame: 8 weeks
measure: Maternal subjective experience of their mental health during and post online yoga
timeFrame: 8 weeks
Secondary outcomes:
measure: Maternal subjective feelings and experience towards the body and bond with infant post partum, during and post online yoga programme
timeFrame: 8 weeks
Other outcomes:
Locations:
city: York
country: United Kingdom
facility: York & Scarborough Teaching Hospitals NHS Foundation Trust
state: N. Yorks
Study officials:
affiliation: York & Scarborough Teaching Hospitals NHS Foundation Trust
name: Deborah Phillips
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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citation: MacDonald C. Mother and baby yoga is good for you. Pract Midwife. 2013 May;16(5):14, 16, 18.
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.
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.
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.
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.