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

Not Applicable

Recruiting

• Conditions: Sleep; Infant, Premature; Hypnosis; Parents
• Interventions: Other: Hypnotherapeutic sound-files

• Registration Number: NCT05808088
• Lead Sponsor: University of Aarhus

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-15
• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-04-10
• Last Update Submitted: 2023-04-10
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1, sound-files from inclusion	Hypnotherapeutic sound-files	-
Group 2, sound-files after 7 days	Hypnotherapeutic sound-files	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Randers Regional Hospital; 🇩🇰 Randers, Denmark