Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05NS16
Study information
Scientific title
Comfortable Babies and Comforting Parents: A randomised controlled trial
Acronym
CBCP
Study hypothesis
Parents of Neonatal Intensive Care Unit (NICU) infants who receive an intervention to increase parental involvement in infant comfort care will have less NICU-related stress (primary outcome) compared to parents who do not receive the intervention
Ethics approval
Institute of Child Health/Great Ormond Street Hospital Research Ethics Committee approved on: 1st November 2006, ref: 06/Q0508/114
Study design
Multisite randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request patient information sheet
Condition
NICU-related stress for parents
Intervention
Intervention and Control Group Activities
1. As part of usual care, parents in both the intervention and control groups received a detailed booklet with generic information about NICU care (Parent Information Guide, published by Bliss, London, UK)
2. Parents in the intervention group received an additional booklet that provided evidence-based information about pain and comforting infants in the NICU setting. The Comforting Your Baby in Intensive Care booklet contains information in lay language on the following 5 topics:
2.1. How acute pain occurs and how it may affect infants
2.2. How infant pain is assessed and managed in the NICU
2.3. The important role parents can play in providing infant comfort
2.4. Specific instructions on comforting techniques for parents to use with their infants (e.g. skin-to-skin holding or non-nutritive sucking during heel puncture)
2.5. Advice on how parents can work in partnership with NICU staff to achieve optimal infant comfort
3. Intervention group parents also received 2 visits (approximately 45 minutes) from a research nurse to show them how to apply the comforting techniques described in the booklet. Parents were encouraged to ask nurses caring for their baby if they require further instruction.
4. Parents in the control group also received 2 visits (approximately 45 minutes) from a research nurse to listen to what parents had to say about their NICU experience (attention placebo)
A four hospital multisite restricted allocation was used, with the four NICU's match-paired and randomly assigned to the intervention or control conditions.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Parent Stressor Scale: NICU (PSS:NICU) (Miles, 1998)- A measure of NICU-related stress, 47-item self-report scale.
1.1. Scores range 1-5, for each item
0 = not applicable
higher mean score indicate higher overall stress
1.2. Subscale scores in 4 dimensions:
Infant appearance
Parental role alteration
NICU environment
Staff communication
Secondary outcome measures
1. Parent Attitudes about Infant Nociception (PAIN) (Franck, 2004)-A measure of parental views about infant pain and its treatment, 38-item self-report scale. Consists of scale, forced choice and free-text response items to describe parents: perceptions and concerns about infant pain and pain treatment; actual and desired level of involvement in infant pain assessment and comfort; satisfaction with staff management of infant comfort.
2. Self-Efficacy in Infant Care (SICS) (Froman, 1989)-A measure of perceived confidence and competency in infant caregiving, 40-item self-report scale (rated 0-10). Total scores range from 0-100; higher scores indicate increased parental confidence in their knowledge and skills with infant care activities in the domains of: development, diet, health and safety.
3. What Being a Parent of a New Baby is Like Revised (WBPBL-R) (Pridham, 1989)- A measure of perceptions of parental role attainment and caregiving performance, 25-item self-report scale. Scores range from 1-9 for each item; higher mean scores indicate more positive perceptions of themselves as parents and of the parenting experience, with subscale scores in 3 dimensions: evaluation (how well parent is meeting own expectations of parenting), centrality (how much the infants care and health on the parents mind) and life change (impact of infant on parents life).
4. Frequency of pain assessment documentation by nurses- Chart audit of the nursing notes. Coded as 0=no notation of pain assessments performed, 1=intermittent pain assessment documentation (by notation or pain scale), 2 = frequent pain documentation (3 or more days).
Overall trial start date
20/10/2006
Overall trial end date
01/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All parents of infants admitted to the NICUs who were over 16 years of age
2. All parents who could read and speak English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
1. Parents with documented psychological or psychiatric conditions
2. Parents of those infants expected to be transferred to another hospital within 10 days of admission
Recruitment start date
20/10/2006
Recruitment end date
01/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Family Health Care Nursing
San Francisco, CA
94143
United States of America
Funders
Funder type
Charity
Funder name
BLISS - The premature baby charity (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21859919
Publication citations
-
Results
Franck LS, Oulton K, Nderitu S, Lim M, Fang S, Kaiser A, Parent involvement in pain management for NICU infants: a randomized controlled trial., Pediatrics, 2011, 128, 3, 510-518, doi: 10.1542/peds.2011-0272.