Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Linda Franck


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Comfortable Babies and Comforting Parents: A randomised controlled trial



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request patient information sheet


NICU-related stress for parents


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



Not Applicable

Drug names

Primary outcome measures

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 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 trial start date


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information


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

Sponsor details

30 Guilford Street
United Kingdom

Sponsor type




Funder type


Funder name

BLISS - The premature baby charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Results - basic reporting

Publication summary

1. 2011 results in

Publication citations

  1. 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.

Additional files

Editorial Notes