Comfortable Babies and Comforting Parents

ISRCTN ISRCTN87094922
DOI https://doi.org/10.1186/ISRCTN87094922
Secondary identifying numbers 05NS16
Submission date
10/02/2011
Registration date
22/02/2011
Last edited
25/04/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Linda Franck
Scientific

Family Health Care Nursing
School of Nursing, Box 0606
2 Koret Way
San Francisco, CA
94143
United States of America

Study information

Study designMultisite randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request patient information sheet
Scientific titleComfortable Babies and Comforting Parents: A randomised controlled trial
Study acronymCBCP
Study objectivesParents 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(s)Institute of Child Health/Great Ormond Street Hospital Research Ethics Committee approved on: 1st November 2006, ref: 06/Q0508/114
Health condition(s) or problem(s) studiedNICU-related stress for parents
InterventionIntervention 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 typeOther
Primary outcome measure1. 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 measures1. 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 infant’s care and health on the parent’s mind) and life change (impact of infant on parent’s 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 study start date20/10/2006
Completion date01/08/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants160
Key inclusion criteria1. All parents of infants admitted to the NICUs who were over 16 years of age
2. All parents who could read and speak English
Key exclusion criteria1. Parents with documented psychological or psychiatric conditions
2. Parents of those infants expected to be transferred to another hospital within 10 days of admission
Date of first enrolment20/10/2006
Date of final enrolment01/08/2009

Locations

Countries of recruitment

  • United Kingdom
  • United States of America

Study participating centre

Family Health Care Nursing
San Francisco, CA
94143
United States of America

Sponsor information

University College London (UCL) Institute of Child Health (UK)
University/education

30 Guilford Street
London
WC1N 1EH
England
United Kingdom

ROR logo https://ror.org/02jx3x895

Funders

Funder type

Charity

BLISS - The premature baby charity (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2011 Yes No
BMC - Part of Springer Nature Springer Nature