Mother and Baby Yoga Study - Early Postnatal Yoga and Mental Health (MABY)

September 20, 2023 updated by: York Teaching Hospitals NHS Foundation Trust

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal subjective experience of their mental health during and post online yoga programme
Time Frame: 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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal subjective feelings and experience towards the body and bond with infant post partum, during and post online yoga programme
Time Frame: 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).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

York Teaching Hospitals NHS Foundation Trust

Collaborators

University of York

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 294028YNP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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