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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808088
• Other study ID #: HGO1
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hypnosis
• Infant, Premature
• Parents
• Sleep

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).