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Comfortable Babies and Comforting Parents

Comfortable Babies and Comforting Parents: A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87094922
Enrollment
160
Registered
2011-02-22
Start date
2006-10-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NICU-related stress for parents Pregnancy and Childbirth NICU-related stress for parents

Interventions

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 In

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026