Psychological StressPhase 1NCT01176188
A Nursing Intervention to Enhance Child Comfort and Psychological Well-Being During and Following PICU Hospitalization
A Phase 1 study testing Comfort Care in people with Psychological Stress, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Children who become critically ill and require Pediatric Intensive Care Unit (PICU)hospitalization may develop negative psychological outcomes following discharge. This pilot study will test a nursing intervention that seeks to promote child comfort, sleep and psychological well-being during and following PICU… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Comfort Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Jul 2013
- Phase
- Phase 1
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child aged 6-17 admitted to the PICU of one Canadian, university teaching hospital
- Child in age-appropriate grade at school (+- 1 year)
- Child can read and speak English or French
- Parent or primary caregiver willing to participate in the intervention, who can read, speak and write English or French
Who cannot join
- Child diagnosed with a sleep disorder, seizure disorder, hearing disorder, or who has had neurological surgery that precludes sleep measurement
- Child expected to die during their PICU stay
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pediatric Intensive Care Unit, The Montreal Children's Hospital, McGill University Health Centre
Montreal, Quebec, H3H 1P3
About this study
Official title: A Nursing Intervention to Enhance Comfort and Promote Psychological Well-Being in Children During and Following PICU Hospitalization: A Pilot Study
Children who become critically ill and require Pediatric Intensive Care Unit (PICU)hospitalization may develop negative psychological outcomes following discharge. This pilot study will test a nursing intervention that seeks to promote child comfort, sleep and psychological well-being during and following PICU hospitalization.
Study objectives are to:
Read more
- test the feasibility and acceptability of a PICU comfort care intervention that can be administered by nursing staff
- examine the feasibility and acceptability of data collection procedures
- pilot test outcome measures
- determine effect sizes to inform sample size calculation for a future multi-centred randomized controlled trial (RCT).
The intervention will take place in the PICU, and consists of a parental soothing activity followed by a quiet period in which earmuffs are placed over the child's ears to block noise. Children's sleep time and comfort level will be monitored in the PICU, and the investigators will follow them for 3 months post-discharge to examine the effects of the intervention on psychological well-being.
Read the detailed description
Background: Children who become critically ill and require Pediatric Intensive Care Unit (PICU) hospitalization may develop negative psychological outcomes following discharge. Despite this concern, there have been no systematic attempts to intervene with critically ill children to promote well-being, and prevent long term sequelae. The aim of this pilot study is to test the feasibility and acceptability of a PICU nursing intervention that seeks to enhance child comfort and promote sleep quality and duration in the PICU, potentially promoting psychological well-being post-discharge. The intervention is based on principles of Developmental Care, a philosophy of care that includes the child and family, and incorporates intervention strategies to reduce environmental stressors and improve quality of life. In view of the critically ill child's state of physical and emotional vulnerability, and the highly noxious environmental stimuli they are exposed to in the PICU, our proposed intervention has the potential to enhance physiological and psychological stability in this population. We will examine intervention effects on children's quality of sleep and sleep duration in the PICU, psychological distress post-PICU, and on parent anxiety during and following their child's PICU hospitalization.
Objectives: (1) To test the feasibility and acceptability of a PICU comfort care intervention that can be administered by nursing staff; (2) to examine the feasibility and acceptability of data collection procedures; (3) to pilot test outcome measures; and (4) to determine effect sizes to inform sample size calculation for a future multi-centred randomized controlled trial (RCT).
Design: A pilot study will be conducted using RCT design.
Outcomes: Results of this pilot study will provide essential information regarding feasibility of recruitment and randomization, as well as feasibility and acceptability of the developmental care intervention and data collection procedures - all of which will be incorporated into a full-scale RCT. While sample size is insufficient to allow statistical analyses, we will obtain initial estimates regarding changes in sleep duration, sleep fragmentation, and psychological well-being post-intervention.
- Conditions
- Psychological Stress
- Being tested
- Comfort Care, Usual care
- Keywords
- Pediatric Intensive Care Unit, Environmental Stressors, Sleep, Psychological Outcomes, Pediatrics
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort CareOther
The intervention will consist of two parts: (1) A 15-20 minute period of parental soothing at the bedside comprised of calming activities which the child and parents are familiar with; (2) A quiet period will follow, in which earmuffs are applied over the child's ears to block auditory stimulation. The intervention will take place twice/24 hours, up to a maximum of 72 hours. Total time of first (daytime) intervention will be 2 hours, and of second (night-time) intervention will be 7 hours.
Usual careOther
Usual nursing care for the child in the Pediatric Intensive Care Unit, including usual parental involvement and usual exposure to unit noise levels.
| Study group | Role | What they receive |
|---|---|---|
| Comfort Care | Experimental | Parental soothing, including tactile and auditory strategies, followed by a quiet period with the application of earmuffs to block auditory stimulation Receives: Other: Comfort Care |
| Usual Care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and feasibility of the comfort intervention
Measured: Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge
Secondary outcomes (5)
Child Distress
Measured: 3 months post-Pediatric Intensive Care Unit discharge
Child Comfort
Measured: During Pediatric Intensive Care Unit stay
Parent Anxiety
Measured: Time 1: During child's Pediatric Intensive Care Unit stay; Time 2: 3 months post-discharge of child
Child Anxiety
Measured: 3 months post-discharge
Child Sleep
Measured: Time 1: During Pediatric Intensive Care Unit stay; Time 2: Hospital Ward; Time 3: 3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Réseau de recherche portant sur les interventions en sciences infirmières du Québec (RRISIQ), Canadian Nurses Foundation (CNF)
- Responsible party
- Principal investigator, Dr. Janet Rennick, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Janet E Rennick, MSN, PhD, Principal investigator, Montreal Children's Hospital, McGill University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176188
- Sponsor's protocol ID
- 09-069-PED
- Status last verified
- Sep 2015
- First submitted
- 4 Aug 2010
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rennick JE, Stremler R, Horwood L, Aita M, Lavoie T, Majnemer A, Antonacci M, Knox A, Constantin E. A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music. Pediatr Crit Care Med. 2018 Jul;19(7):e358-e366. doi: 10.1097/PCC.0000000000001556.
PubMed 29659416
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nursing Intervention to Enhance Comfort and Promote Psychological Well-Being in Children During and Following PICU Hospitalization: A Pilot Study
- ClinicalTrials.gov ID
- NCT01176188
- Acronym / sponsor ID
- 09-069-PED
- Conditions
- Psychological Stress
- Keywords
- Pediatric Intensive Care Unit, Environmental Stressors, Sleep, Psychological Outcomes, Pediatrics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Réseau de recherche portant sur les interventions en sciences infirmières du Québec (RRISIQ), Canadian Nurses Foundation (CNF)
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Aug 2010 (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.
Children who become critically ill and require Pediatric Intensive Care Unit (PICU)hospitalization may develop negative psychological outcomes following discharge. This pilot study will test a nursing intervention that seeks to promote child comfort, sleep and psychological well-being during and following PICU hospitalization.
Study objectives are to:
- test the feasibility and acceptability of a PICU comfort care intervention that can be administered by nursing staff
- examine the feasibility and acceptability of data collection procedures
- pilot test outcome measures
- determine effect sizes to inform sample size calculation for a future multi-centred randomized controlled trial (RCT).
The intervention will take place in the PICU, and consists of a parental soothing activity followed by a quiet period in which earmuffs are placed over the child's ears to block noise. Children's sleep time and comfort level will be monitored in the PICU, and the investigators will follow them for 3 months post-discharge to examine the effects of the intervention on psychological well-being.
Detailed description
Background: Children who become critically ill and require Pediatric Intensive Care Unit (PICU) hospitalization may develop negative psychological outcomes following discharge. Despite this concern, there have been no systematic attempts to intervene with critically ill children to promote well-being, and prevent long term sequelae. The aim of this pilot study is to test the feasibility and acceptability of a PICU nursing intervention that seeks to enhance child comfort and promote sleep quality and duration in the PICU, potentially promoting psychological well-being post-discharge. The intervention is based on principles of Developmental Care, a philosophy of care that includes the child and family, and incorporates intervention strategies to reduce environmental stressors and improve quality of life. In view of the critically ill child's state of physical and emotional vulnerability, and the highly noxious environmental stimuli they are exposed to in the PICU, our proposed intervention has the potential to enhance physiological and psychological stability in this population. We will examine intervention effects on children's quality of sleep and sleep duration in the PICU, psychological distress post-PICU, and on parent anxiety during and following their child's PICU hospitalization.
Objectives: (1) To test the feasibility and acceptability of a PICU comfort care intervention that can be administered by nursing staff; (2) to examine the feasibility and acceptability of data collection procedures; (3) to pilot test outcome measures; and (4) to determine effect sizes to inform sample size calculation for a future multi-centred randomized controlled trial (RCT).
Design: A pilot study will be conducted using RCT design.
Outcomes: Results of this pilot study will provide essential information regarding feasibility of recruitment and randomization, as well as feasibility and acceptability of the developmental care intervention and data collection procedures - all of which will be incorporated into a full-scale RCT. While sample size is insufficient to allow statistical analyses, we will obtain initial estimates regarding changes in sleep duration, sleep fragmentation, and psychological well-being post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comfort Care | Experimental | Other: Comfort CareParental soothing, including tactile and auditory strategies, followed by a quiet period with the application of earmuffs to block auditory stimulation |
| Usual Care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child aged 6-17 admitted to the PICU of one Canadian, university teaching hospital
- Child in age-appropriate grade at school (+- 1 year)
- Child can read and speak English or French
- Parent or primary caregiver willing to participate in the intervention, who can read, speak and write English or French
Key exclusion criteria (2 listed)
- Child diagnosed with a sleep disorder, seizure disorder, hearing disorder, or who has had neurological surgery that precludes sleep measurement
- Child expected to die during their PICU stay
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 |
|---|---|---|
| Comfort CareThe intervention will consist of two parts: (1) A 15-20 minute period of parental soothing at the bedside comprised of calming activities which the child and parents are familiar with; (2) A quiet period will follow, in which earmuffs are applied over the child's ears to block auditory stimulation. The intervention will take place twice/24 hours, up to a maximum of 72 hours. Total time of first (daytime) intervention will be 2 hours, and of second (night-time) intervention will be 7 hours. | Other | Comfort Care |
| Usual careUsual nursing care for the child in the Pediatric Intensive Care Unit, including usual parental involvement and usual exposure to unit noise levels. | Other | Usual Care |
Primary outcome
Acceptability and feasibility of the comfort intervention
Time frame: Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge
5 secondary outcomes
Child Distress
Time frame: 3 months post-Pediatric Intensive Care Unit discharge
Child Comfort
Time frame: During Pediatric Intensive Care Unit stay
Parent Anxiety
Time frame: Time 1: During child's Pediatric Intensive Care Unit stay; Time 2: 3 months post-discharge of child
Child Anxiety
Time frame: 3 months post-discharge
Child Sleep
Time frame: Time 1: During Pediatric Intensive Care Unit stay; Time 2: Hospital Ward; Time 3: 3 months post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
- Derived from this study: PubMed 29659416Rennick JE, Stremler R, Horwood L, Aita M, Lavoie T, Majnemer A, Antonacci M, Knox A, Constantin E. A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music. Pediatr Crit Care Med. 2018 Jul;19(7):e358-e366. doi: 10.1097/PCC.0000000000001556.
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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.
Janet E Rennick, MSN, PhD principal investigator
Montreal Children's Hospital, McGill University Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comfort Care in people with Psychological Stress, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 25 Sep 2015. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability and feasibility of the comfort intervention (time frame: Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge). 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 NCT01176188, which also lists 1 linked publication.
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 25 Sep 2015.