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

Sponsor
York Teaching Hospitals NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT06056609
Collaborator
University of York (Other)
40
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2
23.6
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Yoga
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
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.
Actual Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Yoga - Intervention Group

The participants in the intervention group (n.20) will obtain access to an eight-week online mother and baby programme. They will be given access to one video per week and asked to complete the session at least once within the week. The participants are also free to repeat the session as many times as they wish. The researchers will record the participants access to the online videos. All participants will be asked to complete a daily activity diary. The participants will be asked to complete pre, intermediate, and post intervention questionnaires relating to maternal mental health, body satisfaction, and their feelings about the mother and infant bond. A subset of participants will also undergo a telephone interview upon completion of the study, which will be subject to qualitative analysis. A short two weekly questionnaire will be sent to all participants for the duration of the study to monitor participant mood and allow for follow up should it be deemed necessary.

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

No Intervention: Control Group

The participants in the control group (n. 20) will follow the usual standard care pathway and will be offered access to the programme at the end of the study.

Outcome Measures

Primary Outcome Measures

  1. Maternal subjective experience of their mental health during and post online yoga programme [8 weeks]

    This is an explorative feasibility study which will expand current knowledge on the links between the participation in an online mother and baby yoga programme, and maternal subjective experience with mental health. Mental health related outcomes will be measured using the Edinburgh Postnatal Scale and the Postpartum Specific Anxiety Scale. Using well-established scales will allow for comparisons with other studies. A short two weekly questionnaire will be sent to all participants for the duration of the study. Many clinical studies have found PANAS to be a reliable and valid tool including a randomised study examining the links between a postpartum yoga intervention and first-time mothers psychological wellbeing.

Secondary Outcome Measures

  1. Maternal subjective feelings and experience towards the body and bond with infant post partum, during and post online yoga programme [8 weeks]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 York & Scarborough Teaching Hospitals NHS Foundation Trust York N. Yorks United Kingdom YO31 8HE

Sponsors and Collaborators

  • York Teaching Hospitals NHS Foundation Trust
  • University of York

Investigators

  • Study Chair: Deborah Phillips, York & Scarborough Teaching Hospitals NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
York Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT06056609
Other Study ID Numbers:
  • 294028YNP
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023