Effects of live-performed music therapy, kangaroo care and combination therapy on stress, comfort and bonding in parents of extremely preterm infants

Conditions: parental bonding
Parental stress
10028920
10016214

Registration Number: NL-OMON56802

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 116

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: Difference in cortisol levels before and after all three<br /><br>interventions</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>(A) Difference in Oxytocin levels before and after all three interventions<br /><br>(B) Difference in STAI-6 outcomes before and after all three interventions<br /><br>(C) Difference in PBQ outcomes at inclusion and after 3 weeks<br /><br>(D) Difference in PSS-NICU outcomes at inclusion and after 3 weeks<br /><br>(E) Difference in 10-point numeric rating scale for stress before and after all<br /><br>three interventions<br /><br>(F) Difference between scores of mothers and fathers</p><br>