The aim of this study is to investigate the effects of Kangaroo care (KC), live-performed music therapy (LPMT), and combination therapy (CT) on salivary cortisol (SC) and salivary oxytocin (OT) responses in parents of preterm infants, as well as on…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Family issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: Difference in cortisol levels before and after all three
interventions
Secondary outcome
Secondary endpoints:
(A) Difference in Oxytocin levels before and after all three interventions
(B) Difference in STAI-6 outcomes before and after all three interventions
(C) Difference in PBQ outcomes at inclusion and after 3 weeks
(D) Difference in PSS-NICU outcomes at inclusion and after 3 weeks
(E) Difference in 10-point numeric rating scale for stress before and after all
three interventions
(F) Difference between scores of mothers and fathers
Background summary
Preterm birth is a major public health concern, affecting approximately 10% of
births worldwide. Preterm infants are at a significantly high risk of
experiencing a wide range of complications and developmental problems. Parents
of preterm infants also face a range of challenges, including parental stress,
postnatal bonding difficulties and increased anxiety levels. Live-performed
music therapy (LPMT), kangaroo care (KC), and music therapy during kangaroo
care (CT) are commonly used interventions to improve neonatal and parental
wellbeing. However, limited research exists on the comparative effects of these
interventions on postnatal bonding and anxiety in parents of preterm infants,
and on the underlying hormonal mechanisms that may be involved, such as
salivary cortisol (SC) and salivary oxytocin (OT) responses. Understanding the
differences in these interventions on mothers and fathers can also be
important, given the potential gender differences in the experience of
parenting preterm infants.
Study objective
The aim of this study is to investigate the effects of Kangaroo care (KC),
live-performed music therapy (LPMT), and combination therapy (CT) on salivary
cortisol (SC) and salivary oxytocin (OT) responses in parents of preterm
infants, as well as on postnatal bonding and anxiety. The study aims to
determine whether the effects of these interventions differ between mothers and
fathers of preterm infants. The findings of this research can provide important
insights into effective interventions to improve parental outcomes and bonding
with preterm infants.
Study design
The study will include 58 parent-infant triads. This cohort will consist of
preterm infants with a gestational age of <30 weeks or a birthweight <1000g and
their parents. Parent-infant dyads (either mother-infant dyads or father-infant
dyads) will function as their own controls. We will measure stress responses
and parental interactive behaviours by analysing salivary cortisol (SC) and
salivary oxytocin (OT) levels. These levels will be measured before and after
each intervention, which include LPMT, KC and CT. Short-term stress will be
evaluated through a 10-point numeric rating scale for stress and Parental
Stressor Scale: Neonatal Intensive Care Unit (PSS-NICU), whereas parent-infant
bonding will be measured using a Postpartum Bonding Questionnaire (PBQ) at
inclusion and 3 weeks later. To assess parental anxiety, we will use the
State-Trait Anxiety Inventory - 6 (STAI-6), a shortened version of the STAI,
before and after each therapy intervention. Both LPMT and KC are standard care
interventions in the Neonatal Intensive Care Unit (NICU) of the Beatrix
Children's Hospital.
Intervention
Infants will receive live-performed music therapy by a licenced music therapist
for three to four sessions per week. In the Beatrix Children's Hospital this
is considered standard care. Each session of LPMT will last maximal 30 minutes,
in which 10 to 20 minutes of actual music will be provided. In the sessions,
the music therapist will tailor the contents of the music therapy for each
individual infant. The music therapist will collaborate with parents in
constructing the programme for the sessions. Parents will be actively involved
in the sessions, to stimulate their role as caregiver and empower them.
Kangaroo Care (KC) is a method of caring for preterm infants that involves
skin-to-skin contact between the parent and infant. KC is typically initiated
as soon as possible after birth and can be provided for extended periods,
depending on the infant's condition and the parent's availability. KC is also
considered standard care and is provided at least once a day to preterm infants
admitted to the Neonatal intensive care unit of the Beatrix Children's
Hospital. For extremely preterm infants, KC is an essential part of care as it
is beneficial for the infant's development and growth. During KC, the infant is
placed on the parent's chest, with the infant's head facing the parent's breast
or shoulder. The infant is then covered with a blanket to maintain warmth and
comfort.
LPMT and KC can also be provided simultaneously. The combination therapy of
LPMT and KC involves the use of music therapy interventions while the infant is
undergoing KC. During KC, the infant is placed skin-to-skin on the parent's
chest, and the music therapist provides live music interventions tailored to
the infant's needs. The music therapist may use techniques such as singing,
playing instruments, and gentle vocalizations to promote relaxation and comfort
in both the parent and infant.
Study burden and risks
Data for this study cannot be obtained in another population, as the intention
is to study the effects of live-music, kangaroo care and a combination of these
therapies in parents of extremely preterm infants and its effects on stress,
anxiety and bonding. All interventions are already part of standard care in our
NICU environment, so there is no extra burden for the preterm born infants that
are included in this study. As this intervention may be stress-reducing and
improve bonding for parents as well, it is worthwhile to investigate this.
Understanding the effects on parents is an important aspect of this study, as
family-centered care is a crucial factor in our healthcare system. Although
parents are required to complete questionnaires and provide salivary samples
before and after therapy, participating in the study entails only a minimal and
non-invasive burden. Parents of preterm infants will be provided with all
necessary information and are free to make their own informed decision on
whether or not to participate in this research.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- Mother and father of an infant with a gestational age below 30 weeks and/or
birth weight below 1000 grams
- Parents must both be able to attend at least 1 live-performed music therapy
session, 1 kangaroo-care session and 1 session where the therapies are combined
- Parents >18 years of age
- Written informed consent from parent(s)
Exclusion criteria
- Inability of the parents to understand/speak Dutch
- Prior history of depression either one of the parents (A history of a
diagnosis of depression in parents is a significant predictor of either
maternal or paternal postpartum depression and may influence oxytocin levels)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL85374.042.23 |