A non-traditional complex intervention for the treatment of paediatric sleep problems.

A non-traditional complex intervention for the treatment of paediatric sleep problems. - Paediatric sleep problems; a different approach.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52044

Enrollment

Registered

2021-04-15

Start date

2021-06-09

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Ontwikkelingsstoornissen van het jonge kind self regulation sleep problems

Interventions

Stage 1: Complex intervention of paediatric sleep problems, a combination of two or more intervention types

herbal treatment, massage interventions, sensory information interventions, parental counselling and dietary advise. Stage 2: Experimental group: complex intervention of paediatric sleep problems Co

Eligibility

Age

No minimum to 11 Years

Inclusion criteria

Inclusion criteria: Children aged 6-36 months. Sleep problems; according to the ICSD-3, Insomnia type behavioural; specified to sleep onset, sleep maintenance or a combination of both. One or more signs of dysregulation (crying, unwilling to eat and sleep and inability to state regulation).

Exclusion criteria

Exclusion criteria: Other diagnostic sleep categories according to the ICSD-3 Earlier diagnosed comorbidity provoking sleep problems (e.g. pain, trauma, itch, cancer) Genetic syndrome Prematurity (

Design outcomes

Primary

Measure	Time frame
Outcome variables The feasibility study Stage 1: The feasibility of methods and instruments The possible dropout of participants and reason, if given Preferred treatment outcomes by parents/ caregivers The feasibility of the use of the TIDieR guideline by health professionals and possible reasons for not completing all questions The number of included participants per week and its origin of referral	—

Measure

Time frame

Outcome variables The feasibility study Stage 1: The feasibility of methods and instruments The possible dropout of participants and reason, if given Preferred treatment outcomes by parents/ caregivers The feasibility of the use of the TIDieR guideline by health professionals and possible reasons for not completing all questions The number of included participants per week and its origin of referral

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026