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

• Sponsor: University of Aarhus (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05808088
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Parents; Sleep; Infant, Premature; Hypnosis	Other: Hypnotherapeutic sound-files	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.One group receives the intervention at inclusion, the other group is a control group, but crosses over to intervention halfway through the study.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Hypnotherapeutic Sound-files on the Sleep of Parents in the Neonatal Unit.
• Actual Study Start Date: Mar 15, 2023
• Anticipated Primary Completion Date: Mar 15, 2024
• Anticipated Study Completion Date: Mar 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1, sound-files from inclusion	Other: Hypnotherapeutic sound-files; The participants have access to hypnotherapeutic sound files which they can use as the please.
Active Comparator: Group 2, sound-files after 7 days	Other: Hypnotherapeutic sound-files; The participants have access to hypnotherapeutic sound files which they can use as the please.

Outcome Measures

Primary Outcome Measures

1. Sleep duration [Actigraphy will be worn 2 weeks]

   Via actigraphy sleep duration is measured in minutes

2. Sleep quality [Actigraphy will be worn 2 weeks]

   Sleep quality is data from actigraphy

Secondary Outcome Measures

1. State Anxiety [State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14]

   State-Trait Anxiety Score

2. Trait Anxiety [Trait Anxiety Score are measured at Baseline (inclusion).]

   State-Trait Anxiety Score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Randers Regional Hospital	Randers		Denmark	8930

Sponsors and Collaborators

• University of Aarhus

Investigators

• Principal Investigator: Helle Olesen, Randers Regional Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT05808088
• Other Study ID Numbers: HGO1
• First Posted: Apr 11, 2023
• Last Update Posted: Apr 11, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 11, 2023