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

NCT05808088 | Unknown

• 1 other identifier: HGO1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Parents; Sleep; Infant, Premature; Hypnosis

Outcome Measures

Primary Outcomes (2)

• Sleep duration

  Via actigraphy sleep duration is measured in minutes

  Actigraphy will be worn 2 weeks

• Sleep quality

  Sleep quality is data from actigraphy

  Actigraphy will be worn 2 weeks

Secondary Outcomes (2)

• State Anxiety

  State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14

• Trait Anxiety

  Trait Anxiety Score are measured at Baseline (inclusion).

Study Arms (2)

Group 1, sound-files from inclusion

EXPERIMENTAL

Other: Hypnotherapeutic sound-files

Group 2, sound-files after 7 days

ACTIVE COMPARATOR

Other: Hypnotherapeutic sound-files

Interventions

Hypnotherapeutic sound-files OTHER

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

Group 1, sound-files from inclusion; Group 2, sound-files after 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents of a newborn in the neonatal unit at Randers Regional Hospital

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Randers Regional Hospital

Randers, 8930, Denmark

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Helle Olesen

  Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helle Olesen

CONTACT

+45 78420835; helgoe@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group receives the intervention at inclusion, the other group is a control group, but crosses over to intervention halfway through the study.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 11, 2023
• Study Start: March 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)