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

NCT ID: NCT05808088

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-03-15

Brief Summary

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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

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Conditions

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Parents Sleep Infant, Premature Hypnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

One group receives the intervention at inclusion, the other group is a control group, but crosses over to intervention halfway through the study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 1, sound-files from inclusion

Group Type EXPERIMENTAL

Hypnotherapeutic sound-files

Intervention Type OTHER

The participants have access to hypnotherapeutic sound files which they can use as the please.

Group 2, sound-files after 7 days

Group Type ACTIVE_COMPARATOR

Hypnotherapeutic sound-files

Intervention Type OTHER

The participants have access to hypnotherapeutic sound files which they can use as the please.

Interventions

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Hypnotherapeutic sound-files

The participants have access to hypnotherapeutic sound files which they can use as the please.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helle Olesen

Role: PRINCIPAL_INVESTIGATOR

Randers Regional Hospital

Locations

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Randers Regional Hospital

Randers, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Helle Olesen

Role: CONTACT

+45 78420835

Facility Contacts

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Helle Olesen

Role: primary

+45 78420835

Other Identifiers

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HGO1

Identifier Type: -

Identifier Source: org_study_id

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