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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05808088
Other study ID # HGO1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2023
Est. completion date March 15, 2024

Study information

Verified date March 2023
Source University of Aarhus
Contact Helle Olesen
Phone +45 78420835
Email helgoe@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date March 15, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Randers Regional Hospital Randers

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep duration Via actigraphy sleep duration is measured in minutes Actigraphy will be worn 2 weeks
Primary Sleep quality Sleep quality is data from actigraphy Actigraphy will be worn 2 weeks
Secondary State Anxiety State-Trait Anxiety Score State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14
Secondary Trait Anxiety State-Trait Anxiety Score Trait Anxiety Score are measured at Baseline (inclusion).
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