Breastfeeding
Conditions
Keywords
breast feeding, music therapy, maternal welfare, infant, newborn
Brief summary
The purpose of this study is to evaluate the impact of music therapy on breastfeeding rates among mothers of premature newborns. Hypothesis: Music therapy applied to mothers of premature newborns increases the rates of maternal breastfeeding at the time of the infant hospital discharge and at follow-up visits.
Detailed description
Music therapy has been shown to have positive effects in several areas such as mental health, special education, rehabilitation and social development. Its use as a means to facilitate communication and expression of emotional contents was shown to be able to promote relief of anxiety, fears and tensions. However, in the maternal and child health area there are still few studies demonstrating the contribution of this therapy in the promotion of health and no study evaluating specifically the impact of this intervention on the rates of breastfeeding in mothers of premature newborns.
Interventions
BEHAVIORALMusic therapy
Music therapy sessions systematically offered to all mothers in the intervention group, three times a week, not mandatory, conducted by two music therapists in an appropriate room, during 60 minutes.
Sponsors
Maternidade Escola da UFRJ
Instituto de Puericultura e Pediatria Martagão Gesteira
Universidade Federal do Rio de Janeiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Mothers of premature newborns, with birth weight ≤ 1750 g that have reached clinical stability defined by the medical staff. * To have signed an informed consent to participate in the study.
Exclusion criteria
* Mothers that are HIV (Human Immunodeficiency Virus) positive. * Mothers of neonates with clinical problems that impaired breast suction (encephalopathy with serious hypotonus, oro-facial anomalies, and heart problems). * Mothers with severe hearing deficiencies. Exit Criteria: * Mothers whose neonates died during the hospital stay. * Mothers who, for any reason, had three or less music therapy sessions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Breastfeeding at Infant Discharge | At the time of the infant hospital discharge | Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula). |
| Maternal Breastfeeding 7-15 Days After Discharge | At the first follow-up visit (7-15 days after discharge) | Maternal breastfeeding means: exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Breastfeeding at 30 Days After Discharge | At 30 days after the infant hospital discharge | Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula). |
| Maternal Breastfeeding at 60 Days After Discharge | At 60 days after the infant hospital discharge | Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula). |
Countries
Brazil
Participant flow
Recruitment details
Recruitment period: 03/01/2004 to 07/31/2007. Mothers of LBW newborns (≤ 1750g) that have reached clinical stability and signed an informed consent.
Pre-assignment details
Eligible mothers: 190. Excluded: 89 (26 because their neonates fullfiled one of the exclusion criteria, 18 because their newborns died before being considered in clinical stability, 11 because they did not agree to participate and 34 because they could not be accessed during the newborn hospital stay, most for receiving early hospital discharge).
Participants by arm
| Arm | Count |
|---|---|
| Control | 50 |
| Music Therapy | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 3 newborns died; 1 mother quit the study | 4 | 0 |
| Overall Study | less than 3 music therapy sessions | 0 | 3 |
Baseline characteristics
| Characteristic | Music Therapy | Control | Total |
|---|---|---|---|
| Age, Customized 12-20 years | 13 participants | 13 participants | 26 participants |
| Age, Customized 21-30 years | 27 participants | 22 participants | 49 participants |
| Age, Customized 31-40 years | 9 participants | 12 participants | 21 participants |
| Age, Customized > 40 years | 2 participants | 3 participants | 5 participants |
| Region of Enrollment Brazil | 51 participants | 50 participants | 101 participants |
| Sex: Female, Male Female | 51 Participants | 50 Participants | 101 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 51 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 |
Outcome results
Primary
Maternal Breastfeeding 7-15 Days After Discharge
Maternal breastfeeding means: exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).
Time frame: At the first follow-up visit (7-15 days after discharge)
Population: Analysis was by intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Maternal Breastfeeding 7-15 Days After Discharge | 32 participants |
| Music Therapy | Maternal Breastfeeding 7-15 Days After Discharge | 42 participants |
Comparison: Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the first follow-up visit and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.p-value: 0.0395% CI: [1.01, 1.57]Chi-squared
Primary
Maternal Breastfeeding at Infant Discharge
Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).
Time frame: At the time of the infant hospital discharge
Population: Analysis by intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Maternal Breastfeeding at Infant Discharge | 33 participants |
| Music Therapy | Maternal Breastfeeding at Infant Discharge | 42 participants |
Comparison: Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the infant hospital discharge and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.p-value: 0.0695% CI: [0.99, 1.51]Chi-squared
Secondary
Maternal Breastfeeding at 30 Days After Discharge
Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).
Time frame: At 30 days after the infant hospital discharge
Population: Analysis by intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Maternal Breastfeeding at 30 Days After Discharge | 30 participants |
| Music Therapy | Maternal Breastfeeding at 30 Days After Discharge | 38 participants |
p-value: 0.1395% CI: [0.73, 5.66]Chi-squared
Secondary
Maternal Breastfeeding at 60 Days After Discharge
Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).
Time frame: At 60 days after the infant hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Maternal Breastfeeding at 60 Days After Discharge | 27 participants |
| Music Therapy | Maternal Breastfeeding at 60 Days After Discharge | 36 participants |
p-value: 0.0995% CI: [0.95, 1.71]Chi-squared