VOICE Study in China 'Towards a Partnership Between Parents of Very Premature Infants and Healthcare Professionals'

Summary

Background: Admission to a Neonatal Intensive Care Unit (NICU) is associated with significant levels of parental stress and anxiety. Parents are often uncertain to perform care giving activities and might feel uncertain to fulfill the desirable parental role during NICU admission. Furthermore, transition of the NICU to another unit or hospital is stressful for parents often related to poor information and communication. A VOICE program is developed aiming to increase the empowerment of parents, to improve partnership between parents of very premature infants and healthcare professionals.

Aim: To conduct a feasibility RCT study to evaluate the implementation and the effect of the VOICE program on parental stress and anxiety in the NICU.

Methods:

Design is a feasibility RCT to test the procedures, compliance, determine sample size, estimating recruitment and retention, and to get first insight in the effects of the VOICE program on the outcome measures.

VOICE will be implemented as a structured empowerment and partnership program for parents from admission of the infant to the NICU till the first visit to the out-patient clinic. The program exists of five structured and focused meetings, following the acronym VOICE (Values, Opportunities, Integration, Control and Evaluation). These interdisciplinary meetings with parents aim to increase the involvement of parents in the care and decision making of participants' infant in the NICU. The primary outcome measures will be parental stress and anxiety measured by the Chinese version of the Hospital Anxiety and Depression scale (HADS) and the Edinburgh Postnatal Depression Scale (Chinese version). The secondary outcome measures will be parent satisfaction with care measured by the Empowerment of Parents in the Intensive Care (EMPATHIC-30) scale, length-of-stay in the NICU, hours of parental visitation and activities, compliance of NICU staff to the VOICE program.

An embedded qualitative study will be designed to explore the experiences of parents and NICU staff about the implemented VOICE program. Individual interviews with parents and focus groups sessions with NICU staff will be conduction. This will help to identify methodological issues such as recruitment and retention and any enablers and barriers to the intervention which may impede the future RCT.

Conditions

• Emotional Stress
• Parents
• Family Separation
• Neonatal Intensive Care
• Parents Support
• Family Centered Care
• Infant ALL

Interventions

BEHAVIORAL

VOICE care

I phase:build a relationship with parents and where the Values of the parents and NICU staff is shared. II phase: discuss with the parents the Opportunities the parents can have to be more involved in the care of their baby. III phase: Integration of the involvement of the parents in the care of their baby. The experiences of parents need to be shared with the NICU staff. Any raising issue about the involvement of care by the parents can be discussed and see if improvement is needed. IV phase:Control of the knowledge about the care of their baby before going home and if the parents have any issues which need to be arranged before discharge. V phase:Evaluation. During this conversation the overall experiences of the parents will be discussed and if there are any further questions related to the care of their baby at home will be explored and discussed.

Sponsors & Collaborators

• Hunan Children's Hospital

  lead OTHER_GOV

Principal Investigators

• Xiao-ming Peng · Hunan Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2022-11-30

Completion

2023-01-31