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

April 10, 2023 updated by: University of Aarhus

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Helle Olesen
  • Phone Number: +45 78420835
  • Email: helgoe@rm.dk

Study Locations

  • Denmark
      • Randers, Denmark, 8930
        • Recruiting
        • Randers Regional Hospital
        • Contact:
          • Helle Olesen
          • Phone Number: +45 78420835
          • Email: helgoe@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep duration
Time Frame: Actigraphy will be worn 2 weeks
Via actigraphy sleep duration is measured in minutes
Actigraphy will be worn 2 weeks
Sleep quality
Time Frame: Actigraphy will be worn 2 weeks
Sleep quality is data from actigraphy
Actigraphy will be worn 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Anxiety
Time Frame: State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14
State-Trait Anxiety Score
State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14
Trait Anxiety
Time Frame: Trait Anxiety Score are measured at Baseline (inclusion).
State-Trait Anxiety Score
Trait Anxiety Score are measured at Baseline (inclusion).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Helle Olesen, Randers Regional Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Anticipated)

March 15, 2024

Study Completion (Anticipated)

March 15, 2024

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HGO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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