Feasibility Study of a Music and Social Support Intervention for Postnatal Mothers/Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-16

Study Completion Date

2024-04-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research study aims to assess the feasibility of conducting a full scale trial of Mamas in Harmony, a group music and social support class delivered by a professional musician for mothers and their babies. Classes for Mamas in Harmony run for 1 hour each week for 8 weeks at a community venue with 10-12 mothers and babies in each class.

The aim of this study is to conduct a pilot randomised controlled trial and process evaluation to assess recruitment rate, retention rate, adherence rate to the study protocol, attendance rate for the intervention, completion rate of outcome measurement tools, acceptability of the intervention, and barriers/facilitators for study participation and intervention delivery.

This feasibility study aims to recruit 60 mothers and babies. Forty will be randomly allocated to the intervention group of Mamas in Harmony and receive standard postnatal care and twenty will receive standard postnatal care only, as the control group.

All mothers will be asked to complete study questionnaires at three time points over a 6 month period to assess their mental health and wellbeing and bonding with their baby.

Mothers will also be asked if they wish to share their opinions and experiences about the research study and Mamas in Harmony classes (if they were allocated to that group) in an interview, to provide their thoughts, whether anything made it easy/difficult for them to participate and whether they have any suggestions on how to improve the study procedure.

The musician will also be asked for their experiences on the barriers and facilitators of intervention delivery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Music on Fear of Childbirth and Outcome of Delivery

NCT01687907

Fear of Childbirth

UNKNOWN NA

The Effect of Music Therapy Applied to Pregnant Women on Anxiety and Stress

NCT05195307

Music Therapy

COMPLETED NA

The Effect of Music Therapy on Labour Pain, Anxiety, and Analgesia

NCT05149677

Labor Pain

UNKNOWN NA

The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort

NCT06053931

Music Breastfeeding Newborn +1 more

UNKNOWN NA

The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery

NCT01049477

Pregnancy Cesarean Section

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Perinatal mental health problems have the potential to lead to multiple negative outcomes for both mother and child, and mental health in the perinatal period is a current leading public health issue with significant economic burden if untreated. The perinatal period lasts for the duration of pregnancy and for 1 year after the birth of the child. Symptoms of low mood, anxiety, stress, feeling isolated, and difficulties with mother-infant attachment are frequently experienced by both antenatal and postnatal mothers. It is reported that anxiety is often overlooked in the perinatal period, with limited research carried out in relation to perinatal anxiety compared to depression, with little knowledge around epidemiology or effectiveness of interventions for perinatal mental health conditions other than postnatal depression (PND). This is despite associations found between maternal anxiety and adverse outcomes for the child.

Studies investigating the effect of poor postnatal mental health have found an adverse impact on mother-infant attachment, bonding, self-regulation and empathy. Consequently, mothers find it difficult to engage with their infants both emotionally and behaviourally resulting in reducing their physical contact.

Regular screening for perinatal depression and anxiety disorders by health professionals is recommended in the UK by National Institute for Health and Care Excellence (NICE) guidelines from the first contact with the mother, throughout pregnancy and the postnatal period using assessment tools. However, postnatal mental health problems often go unidentified, undiagnosed, and untreated for many women or they do not meet the eligibility threshold for specialist mental health services after the birth of their baby.

Current pharmacological treatment options offered by health professionals involved in the care of mothers often have potential for side effects and low uptake and adherence, especially for breastfeeding mothers. Psychotherapy has presented challenges of mixed results, and short-lived improvements. Consequently there has been an increase in interest in non-pharmacological interventions, such as arts in health programmes.

Strong evidence supports the arts in improving wellbeing and quality of life among adults. Arts in health activities are wide ranging and, in particular, include performing arts, such as music. The gap that remains in current literature is an arts in health based group intervention for mother-infant dyads, supporting the reduction in symptoms of anxiety and stress, promoting social support and targeting an improvement in the mother-infant relationship.

This study will seek to explore the feasibility and the potential benefit of a new mother-infant group intervention, Mamas in Harmony, that combines group music classes with social support using a pilot randomised controlled trial and process evaluation.

Sixty mother-infant dyads aim to be recruited via social media, including Facebook and Twitter, and recruitment posters on communal/public facing noticeboards. Local Women's and Community Centres, community mother and baby classes, social support organisations and SureStart Children's Centres (Department for Education funded) will be asked to display posters/flyers. Following informed consent and baseline data collection, mothers will be randomly allocated using a 2:1 ratio to the intervention or control group. Mamas in Harmony sessions will be delivered by a professional musician/choir leader in a community venue face to face in groups of 10-12 mother-infant dyads, for 1 hour each week for 8 weeks along with their usual postnatal care from health and social care services. The control group receive usual postnatal care only.

All mothers will be invited to complete questionnaires at baseline (prior to randomisation), 3 months and 6 months post-randomisation either online or posted in paper format to assess completion rates of measurement tools for anxiety, depression, perceived stress, parenting confidence, perceived social support, mother-infant attachment, health related quality of life and service and resource use.

Study registers will be used to assess recruitment rate, retention rate, adherence to the study protocol and attendance rate for the intervention.

Evaluation forms will be administered to the intervention group in week 8 and semi structured interviews completed online with a subset of 8 mothers from intervention and control groups at the end of the study to establish acceptability, and maternal satisfaction with the intervention and/or research study, as applicable. Semi structured interview/s will be conducted with the intervention facilitator/s to allow an understanding of the facilitators' perspectives of barriers and facilitators for intervention delivery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mamas in Harmony (and usual care)

Mamas in Harmony is a 1 hour face to face intervention for mothers and their infants, delivered in groups of 10-12 mother-infant dyads, every week for 8 weeks. Mothers and infants also receive usual postnatal care from health and social care services.

Group Type EXPERIMENTAL

Mamas in Harmony

Intervention Type BEHAVIORAL

Mothers attend 8x 1 hour weekly classes with their infant. Classes take place in a community venue. Mothers sit with their infant on the floor in circle formation on cushioned mats. Group singing facilitated for 40 minutes by the intervention facilitator, a professional musician/choir leader. A mix of songs are introduced that are easy to learn without the need for lyric sheets. Mothers will be encouraged to sing along. Mothers will be encouraged to interact with their infant through various sensory stimuli involving touch, sound and visual. The end of each singing session involves a short period of quiet time, soothing sounds are provided by the intervention facilitator using voice and instruments. 20 minutes of facilitated social support will follow and mothers will be provided with refreshments. Mothers will be encouraged to interact with other mothers to promote social connection.

Control (usual care only)

Mothers and infants receive usual postnatal care from health and social care services.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mamas in Harmony

Mothers attend 8x 1 hour weekly classes with their infant. Classes take place in a community venue. Mothers sit with their infant on the floor in circle formation on cushioned mats. Group singing facilitated for 40 minutes by the intervention facilitator, a professional musician/choir leader. A mix of songs are introduced that are easy to learn without the need for lyric sheets. Mothers will be encouraged to sing along. Mothers will be encouraged to interact with their infant through various sensory stimuli involving touch, sound and visual. The end of each singing session involves a short period of quiet time, soothing sounds are provided by the intervention facilitator using voice and instruments. 20 minutes of facilitated social support will follow and mothers will be provided with refreshments. Mothers will be encouraged to interact with other mothers to promote social connection.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Mothers who have a baby aged ≥14 days to ≤4 months at time of consent.
* Able and willing to provide consent identified by having a satisfactory understanding of English and comprehension of the participant information sheet and consent form.

Exclusion Criteria

* Mothers who have given birth in the last 14 days.
* Infants \>4 months at time of consent.
* Identified as not having satisfactory understanding of English and comprehension of the participant information sheet and consent form.
* Mothers who have received a diagnosis of, or being treated for, severe mental illness including Bipolar disorder, Psychoses or Schizophrenia within the past 6 months (discovered through self-report at time of eligibility screening).

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes