ParentsNCT05808088
The Effect of Hypnotherapeutic Sound-files on the Sleep of Parents in the Neonatal Unit.
A study testing Hypnotherapeutic sound-files in people with Parents and Sleep, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parents, Sleep, Infant, Premature
- What is being tested?
- Hypnotherapeutic sound-files
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents of a newborn in the neonatal unit at Randers Regional Hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Randers Regional Hospital
Randers, 8930
Helle Olesen, +45 78420835, helgoe@rm.dk
About this study
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
- Being tested
- Hypnotherapeutic sound-files
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotherapeutic sound-filesOther
The participants have access to hypnotherapeutic sound files which they can use as the please.
| Study group | Role | What they receive |
|---|---|---|
| Group 1, sound-files from inclusion | Experimental | Not described Receives: Other: Hypnotherapeutic sound-files |
| Group 2, sound-files after 7 days | Active comparator | Not described Receives: Other: Hypnotherapeutic sound-files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration
Via actigraphy sleep duration is measured in minutes
Measured: Actigraphy will be worn 2 weeks
Sleep quality
Sleep quality is data from actigraphy
Measured: Actigraphy will be worn 2 weeks
Secondary outcomes (2)
State Anxiety
State-Trait Anxiety Score
Measured: State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14
Trait Anxiety
State-Trait Anxiety Score
Measured: Trait Anxiety Score are measured at Baseline (inclusion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start15 Mar 2023
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helle Olesen, Principal investigator, Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808088
- Sponsor's protocol ID
- HGO1
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypnotherapeutic Sound-files on the Sleep of Parents in the Neonatal Unit.
- ClinicalTrials.gov ID
- NCT05808088
- Acronym / sponsor ID
- HGO1
- Conditions
- Parents, Sleep, Infant, Premature, Hypnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1, sound-files from inclusion | Experimental | Other: Hypnotherapeutic sound-files |
| Group 2, sound-files after 7 days | Active comparator | Other: Hypnotherapeutic sound-files |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of a newborn in the neonatal unit at Randers Regional Hospital
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnotherapeutic sound-filesThe participants have access to hypnotherapeutic sound files which they can use as the please. | Other | Group 1, sound-files from inclusion, Group 2, sound-files after 7 days |
Primary outcome
Sleep duration
Time frame: Actigraphy will be worn 2 weeks
Via actigraphy sleep duration is measured in minutes
Sleep quality
Time frame: Actigraphy will be worn 2 weeks
Sleep quality is data from actigraphy
2 secondary outcomes
State Anxiety
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle Olesen principal investigator
Randers Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapeutic sound-files in people with Parents and Sleep, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helle Olesen (+45 78420835, helgoe@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration (time frame: Actigraphy will be worn 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.