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Clinical Trials/NCT05808088
NCT05808088
Recruiting
Not Applicable

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

University of Aarhus1 site in 1 country45 target enrollmentMarch 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parents
Sponsor
University of Aarhus
Enrollment
45
Locations
1
Primary Endpoint
Sleep duration
Status
Recruiting
Last Updated
3 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
March 15, 2023
End Date
March 15, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Sleep duration

Time Frame: Actigraphy will be worn 2 weeks

Via actigraphy sleep duration is measured in minutes

Sleep quality

Time Frame: Actigraphy will be worn 2 weeks

Sleep quality is data from actigraphy

Secondary Outcomes

  • Trait Anxiety(Trait Anxiety Score are measured at Baseline (inclusion).)
  • State Anxiety(State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14)

Study Sites (1)

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