Sleep QualityNeo-SIPaSNCT03004677
Effect of Skin-to-skin Contact on Interaction and Parents' Sleep
A study testing Continuous skin-to-skin contact in people with Sleep Quality and Communication, run by Linkoeping University at 3 sites in Sweden.
Trial summary
This study evaluates the effect of a late intervention of continuous skin-to-skin contact (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the intervention and the other half will receive standard care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Quality, Communication, Stress Reaction
- What is being tested?
- Continuous skin-to-skin contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesSweden
- Study dates
- Jan 2017to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents staying at the NICU with a single preterm infant born <33 weeks of gestation
- The family should have been transferred to family-room from intensive care
- Swedish speaking parents
Who cannot join
- Infants with major congenital malformation,
- Infants with intraventricular hemorrhage grade III-IV
- Infants with chromosome defect that could affect the infant´s ability to interact.
- Parents with sleeping disorder
- Parents with psychiatric problem or drug use.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
University Hospital
Linköping
University hospital Örebro
Örebro
Uppsala University Hospital
Uppsala
About this study
This study evaluates the effect of a late intervention of continuous skin-to-skin contact (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the intervention and the other half will receive standard care.
Read the detailed description
The intervention is based on a method developed to facilitate closeness and human touch between parents and preterm infants in neonatal intensive care. Continuous skin-to-skin contact (SSC) means, in this study, that the late preterm infant is cared for skin-to-skin on the parents' chest, instead of in a heating-bed, 24 hours a day. The parents will take turns to care for the infant in SSC.
- Conditions
- Sleep Quality, Communication, Stress Reaction
- Being tested
- Continuous skin-to-skin contact, Standard Care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Communication, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous skin-to-skin contactBehavioural
Infants will rest in skin-to-skin contact on parents' chest 24 hours a day alternating between the parents. The parents will note who provides the SSC and if and for how long they are off SSC for any reason.
Standard CareOther
Infants will receive regular care in the NICU. Parents may practice SSC if they like. Parents will note if, with whom, and for how long they provide SSC.
| Study group | Role | What they receive |
|---|---|---|
| Continuous skin-to-skin contact | Experimental | Infants assigned to SSC will rest skin-to-skin on parents' chest 24 hours a day for four days alternating between the parents. Receives: Behavioral: Continuous skin-to-skin contact |
| Standard Care | Active comparator | Infants and parents will receive standard care provided in the NICU Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
sleep diary every day for five days
Measured: Day 1 to 5
Secondary outcomes (5)
Mood
Mood Adjective Checklist (MACL)
Measured: day 2 to 5
Bonding
Mother to Infant Bonding Scale (MIBS)
Measured: Baseline and 1-3 days before planned discharge from the NICU.
Depression
The Edinburgh Postnatal Depression Scale, EPDS
Measured: Baseline and 1-3 days before planned discharge from the NICU.
Anxiety
State Trait Anxiety Inventory, STAI
Measured: Baseline and 1-3 days before planned discharge from the NICU.
Activity
Actigraph every day for five days
Measured: Day 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: To difficult to recruit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Evalotte Morelius, Linkoeping University
- Investigators
- Evalotte Mörelius, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004677
- Sponsor's protocol ID
- Linkoeping University
- Acronym
- Neo-SIPaS
- Status last verified
- Mar 2020
- First submitted
- 10 Dec 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Morelius E, Olsson E, Sahlen Helmer C, Thernstrom Blomqvist Y, Angelhoff C. External barriers for including parents of preterm infants in a randomised clinical trial in the neonatal intensive care unit in Sweden: a descriptive study. BMJ Open. 2020 Dec 4;10(12):e040991. doi: 10.1136/bmjopen-2020-040991.
PubMed 33277288Angelhoff C, Blomqvist YT, Sahlen Helmer C, Olsson E, Shorey S, Frostell A, Morelius E. Effect of skin-to-skin contact on parents' sleep quality, mood, parent-infant interaction and cortisol concentrations in neonatal care units: study protocol of a randomised controlled trial. BMJ Open. 2018 Aug 1;8(7):e021606. doi: 10.1136/bmjopen-2018-021606.
PubMed 30068615
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skin-to-skin Contact on Interaction and Parents' Sleep
- ClinicalTrials.gov ID
- NCT03004677
- Acronym / sponsor ID
- Neo-SIPaS / Linkoeping University
- Conditions
- Sleep Quality, Communication, Stress Reaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To difficult to recruit.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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.
This study evaluates the effect of a late intervention of continuous skin-to-skin contact (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the intervention and the other half will receive standard care.
Detailed description
The intervention is based on a method developed to facilitate closeness and human touch between parents and preterm infants in neonatal intensive care. Continuous skin-to-skin contact (SSC) means, in this study, that the late preterm infant is cared for skin-to-skin on the parents' chest, instead of in a heating-bed, 24 hours a day. The parents will take turns to care for the infant in SSC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous skin-to-skin contact | Experimental | Behavioral: Continuous skin-to-skin contactInfants assigned to SSC will rest skin-to-skin on parents' chest 24 hours a day for four days alternating between the parents. |
| Standard Care | Active comparator | Other: Standard CareInfants and parents will receive standard care provided in the NICU |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parents staying at the NICU with a single preterm infant born <33 weeks of gestation
- The family should have been transferred to family-room from intensive care
- Swedish speaking parents
Key exclusion criteria (5 listed)
- Infants with major congenital malformation,
- Infants with intraventricular hemorrhage grade III-IV
- Infants with chromosome defect that could affect the infant´s ability to interact.
- Parents with sleeping disorder
- Parents with psychiatric problem or drug use.
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 |
|---|---|---|
| Continuous skin-to-skin contactInfants will rest in skin-to-skin contact on parents' chest 24 hours a day alternating between the parents. The parents will note who provides the SSC and if and for how long they are off SSC for any reason. | Behavioural | Continuous skin-to-skin contact |
| Standard CareInfants will receive regular care in the NICU. Parents may practice SSC if they like. Parents will note if, with whom, and for how long they provide SSC. | Other | Standard Care |
Primary outcome
Sleep quality
Time frame: Day 1 to 5
sleep diary every day for five days
5 secondary outcomes
Mood
Time frame: day 2 to 5
Bonding
Time frame: Baseline and 1-3 days before planned discharge from the NICU.
Depression
Time frame: Baseline and 1-3 days before planned discharge from the NICU.
Anxiety
Time frame: Baseline and 1-3 days before planned discharge from the NICU.
Activity
Time frame: Day 1-5
Results and safety
The study was stopped early (reason given: To difficult to recruit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 33277288Morelius E, Olsson E, Sahlen Helmer C, Thernstrom Blomqvist Y, Angelhoff C. External barriers for including parents of preterm infants in a randomised clinical trial in the neonatal intensive care unit in Sweden: a descriptive study. BMJ Open. 2020 Dec 4;10(12):e040991. doi: 10.1136/bmjopen-2020-040991.
- Derived from this study: PubMed 30068615Angelhoff C, Blomqvist YT, Sahlen Helmer C, Olsson E, Shorey S, Frostell A, Morelius E. Effect of skin-to-skin contact on parents' sleep quality, mood, parent-infant interaction and cortisol concentrations in neonatal care units: study protocol of a randomised controlled trial. BMJ Open. 2018 Aug 1;8(7):e021606. doi: 10.1136/bmjopen-2018-021606.
- Individual participant dataSharing planned: No
Related trials for Sleep Quality
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
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.
Evalotte Mörelius, PhD principal investigator
Linkoeping University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous skin-to-skin contact in people with Sleep Quality and Communication, run by Linkoeping University at 3 sites in Sweden.
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 3 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: stopped early, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
The study was stopped early (reason given: To difficult to recruit.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: Day 1 to 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004677, which also lists 2 linked publications.
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 4 Mar 2020.