The Effect of Hypnotherapeutic Sound-files on the Sleep of Parents in the Neonatal Unit.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05808088

Enrollment

Registered

2023-04-11

Start date

2023-03-15

Completion date

2024-03-15

Last updated

2023-04-11

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

Conditions

Hypnosis, Infant, Premature, Parents, Sleep

Brief summary

The goal of this randomised study is to learn about, the effect of hypnotherapeutic sound-files on the sleep of parents of infants in the neonatal unit. The main questions it aims to answer are: * Can hypnotherapeutic sound-files make parents of infants in the neonatal unit sleep longer and better? * Does hypnotherapeutic sound-files effect the state anxiety score of parents of infants in the neonatal unit? Participants will have access to sound-files and: * wear actigraphy sleep registration * complete state-trait anxiety score

Interventions

OTHERHypnotherapeutic sound-files

The participants have access to hypnotherapeutic sound files which they can use as the please.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

One group receives the intervention at inclusion, the other group is a control group, but crosses over to intervention halfway through the study.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Parents of a newborn in the neonatal unit at Randers Regional Hospital

Exclusion criteria

* Age under 18 * Hearing disability to an extend where sound-files cannot be used * Psychotic diagnosis, including schizophrenia and personality disorder * Already using hypnotherapeutic sound-files * The use of sleep medication.

Design outcomes

Primary

Measure	Time frame	Description
Sleep duration	Actigraphy will be worn 2 weeks	Via actigraphy sleep duration is measured in minutes
Sleep quality	Actigraphy will be worn 2 weeks	Sleep quality is data from actigraphy

Secondary

Measure	Time frame	Description
State Anxiety	State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14	State-Trait Anxiety Score
Trait Anxiety	Trait Anxiety Score are measured at Baseline (inclusion).	State-Trait Anxiety Score

Countries

Denmark

Contacts

Primary ContactHelle Olesen

helgoe@rm.dk+45 78420835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026