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

Primary Purpose

Mental Health Issue, Depression, Postpartum, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Yoga
Sponsored by
York Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Health Issue

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • York & Scarborough Teaching Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Yoga - Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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

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).

Full Information

First Posted
September 5, 2023
Last Updated
September 20, 2023
Sponsor
York Teaching Hospitals NHS Foundation Trust
Collaborators
University of York
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1. Study Identification

Unique Protocol Identification Number
NCT06056609
Brief Title
Mother and Baby Yoga Study - Early Postnatal Yoga and Mental Health
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
York Teaching Hospitals NHS Foundation Trust
Collaborators
University of York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: Identify possible links between participation a in programme of mother and baby yoga and maternal subjective experience with mental health Verify whether mother and baby yoga can influence mothers feelings about the bond with their baby 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Depression, Postpartum, Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga - Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
An 8 week online mother and baby yoga programme to include daily diary completion and questionnaires at designated study timepoints
Primary Outcome Measure Information:
Title
Maternal subjective experience of their mental health during and post online yoga programme
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Maternal subjective feelings and experience towards the body and bond with infant post partum, during and post online yoga programme
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All eligible participants must be assigned female at birth
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Phillips
Phone
07464491875
Email
deborah.phillips23@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Mia Porteous
Phone
01904725129
Email
mia.porteous2@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Phillips
Organizational Affiliation
York & Scarborough Teaching Hospitals NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
York & Scarborough Teaching Hospitals NHS Foundation Trust
City
York
State/Province
N. Yorks
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Phillips
Phone
07464491875
Email
deborah.phillips23@nhs.net
First Name & Middle Initial & Last Name & Degree
Mia Porteous
Phone
01904725129
Email
mia.porteous2@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32419558
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.
Results Reference
background
PubMed Identifier
16673041
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.
Results Reference
background
PubMed Identifier
8856422
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.
Results Reference
background
PubMed Identifier
22818031
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.
Results Reference
background
PubMed Identifier
27571782
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.
Results Reference
background
PubMed Identifier
25535930
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.
Results Reference
background
PubMed Identifier
23789249
Citation
MacDonald C. Mother and baby yoga is good for you. Pract Midwife. 2013 May;16(5):14, 16, 18.
Results Reference
background
PubMed Identifier
25896571
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.
Results Reference
background
PubMed Identifier
28129548
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.
Results Reference
background
PubMed Identifier
21969408
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.
Results Reference
background
PubMed Identifier
3397865
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.
Results Reference
background
Links:
URL
https://www.bestbeginnings.org.uk
Description
London: Best Beginnings [updated 2020 August 06, cited 2020 August 06];
URL
https://www.npeu.ox.ac.uk
Description
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
URL
https://www.england.nhs.uk/mental-health/taskforce/imp
Description
NHS England, Improvement NHS, for Mental Health NCC, Others. Implementing the Mental Health Forward View. London: NHS England [Internet] 2017
URL
https://www.nice.org.uk/guidance/qs37
Description
National Institute for Health and Care Excellence (NICE). Postnatal care. Quality standard (QS37). London: NICE. [updated: 01 2015 June, cited 2020 August];
URL
https://youtu.be/ZtVVHRzYy4A
Description
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
URL
https://www.rcpsych.ac.uk/mental-health/treatments-and-wellbeing/perinatal-care-and-covid-19
Description
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]
URL
https://www.unicef.org.uk/babyfriendly/wp-content/uploads/sites/2/2018/04/happybaby_leaflet_web.pdf
Description
The Baby Friendly Initiative. Building a Happy Baby A Guide for Parents [Internet]; London: UNICEF UK [updated 2019 March, cited 2020 August].

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

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