About this trial
The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health.
The main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The study population consisted of parents/caregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of ≤32 weeks and expected hospitalizations of at least three weeks. In the case of a twin pregnancy, the firstborn infant was randomly assigned to one of the intervention groups, while both infants received the same treatment according to the outcome of randomization.
Mother a total score of ≥10 and/or father a total score of ≥7 on the EPDS (Edinburgh Postnatal Depression Scale)
Mother and/or father a total score of ≥8 on the GAD-7 (Generalized Anxiety Disorder Scale)
Disqualifiers
Parents/caregivers with known auditory problems that prevent participation in MT.
Parents/caregivers of premature infants in palliative or end-of-life care, infants with known hearing impairment, or infants in the custody of social services.
Trial design
Parallel
Treatments tested in this trial
Music therapy songwriting
Other interventionSession 1: The goal of the first music therapy session is to know the parents musically and to provide information about song creation. This is achieved by exploring their favorite songs. Options for creating a song (original song or song parody) are presented and possibilities for creating lyrics are discussed. Sessions 2-7: The structure of the song will be created and discussed with the parents. Parents will also be invited to include written messages from other family members in the lyrics if they wish. In each session, the developing welcome song is sung together with the parents, accompanied by the music therapist, who provides vocal or instrumental support. The final sessions (Sessions 8-9) are dedicated to singing the final version of the song with the parents and their infant. Should the parents desire, a final recording of the song will also be made and the digital songbook will be created.
Treatment groups
Trial outcomes
Primary outcomes
Postpartum depression
Postpartum depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS). This scale has values between 0 to 30 points. Higher scores mean a worse outcome.
Secondary outcomes
Anxiety
Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7). Minimum and maximum possible scores of 0 and 21 respectively. Higher scores mean a worse outcome.
Well-being
The Warwick Edinburgh Mental Well-Being Scale (WEMWBS) will be employed to assess well-being. Minimum and maximum possible scores of 14 and 70 respectively. Higher scores mean a better wellbeing.
Resilience
Resilience will be assessed with the Brief Resilience Scale (BRS). Participants respond on a 5-point Likert scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) and giving a range from 6-30. Higher scores mean a better resilience.
Stress
Stress will be assessed with the 10-item Perceived Stress Scale (PSS-10). Answers are then scored on Likert scale from 0 "Never" to 4 "Very often". Higher scores indicate higher levels of perceived stress.
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