Musical intervention for extremely preterm infants during NICU stay: a feasibility pilot study

Musical intervention for extremely preterm infants during NICU stay: a feasibility pilot study - Live-music for preterm infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48523

Enrollment

Registered

2019-07-30

Start date

2019-08-08

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Interventions

A music therapist will provide the infants with three weeks of live-music, including two sessions per week. Each session of live-music (two times a week) will last maximal 30 minutes, in which 10 to

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Extremely preterm children (gestational age

Exclusion criteria

Exclusion criteria: Inability of the parents to understand/speak Dutch

Design outcomes

Primary

Measure	Time frame
For the current protocol we define the concept of feasibility as follows: (a) Drop-out of children is lower than 20% (b) The sessions are not increasing stress for the child (c) Participant rate of parents is >50% (d) >50% of parents evaluate the intervention as positive (e) >50% of caregivers evaluate the intervention as positive A drop-out regards children that are not stable enough to participate in the sessions. This stability is determined by the treating physician and nurses. Before, during and after each session, the music therapist will rate the COMFORT-neo score of a child. These scores will be used to determine whether the sessions are stressful for a child. During each session the heart rate, blood pressure, respiration rate and oxygen saturation will be registered. In the second week of therapy, General Movements (GMs) will be filmed before and in the 2 hours after a session. Before the study period, after 3 weeks and after 6 weeks, GMs will also be filmed, a stool sample will be collected and parents will fill in a State and Trait Anxiety Inventory (STAI) and Beck's Depression Inventory. At three months of age, all children will again be videotaped to study Fidgety Movements (FMs).	—

Measure

Time frame

For the current protocol we define the concept of feasibility as follows: (a) Drop-out of children is lower than 20% (b) The sessions are not increasing stress for the child (c) Participant rate of parents is >50% (d) >50% of parents evaluate the intervention as positive (e) >50% of caregivers evaluate the intervention as positive A drop-out regards children that are not stable enough to participate in the sessions. This stability is determined by the treating physician and nurses. Before, during and after each session, the music therapist will rate the COMFORT-neo score of a child. These scores will be used to determine whether the sessions are stressful for a child. During each session the heart rate, blood pressure, respiration rate and oxygen saturation will be registered. In the second week of therapy, General Movements (GMs) will be filmed before and in the 2 hours after a session. Before the study period, after 3 weeks and after 6 weeks, GMs will also be filmed, a stool sample will be collected and parents will fill in a State and Trait Anxiety Inventory (STAI) and Beck's Depression Inventory. At three months of age, all children will again be videotaped to study Fidgety Movements (FMs).

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)