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

May 19, 2022 updated by: Hunan Children's Hospital

VOICE: Values, Opportunities, Integration, Control and Evaluation: Towards a Partnership Between Parents of Very Premature Infants and Healthcare Professionals in China

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND AND RATIONAL Preterm birth and admission at the Neonatal Intensive Care Unit (NICU) can be stressful and traumatic events both for parents and infants.

Infants born very premature are usually admitted to a NICU. A multidisciplinary dedicated team takes care of these infants and parents. Admission to a NICU is essential if the infant requires additional life support for their vital functions after birth. NICU admission is associated with high rates of impaired development of the infants, and parents or families often experience significant disruption, stress and anxiety during NICU admission and beyond.

Depending the diagnostic criteria, 6.8-16.5% of the mothers suffers of post-partum depression. Elevated stress levels and depressive symptoms are present upon NICU admission. Besides the normal stress of parenthood, parental distress is related to different factors such as physical and emotional isolation from the infant, a lack of control, adapting the idea of having a sick infant and the stress of the NICU environment.

During admission, support of nurses and doctors is important; when perception of nursing support is decreasing, mothers' depressive symptoms are increasing. Stress is known to negatively influence the parent-child relationship. Schappin concluded that stress decreases by better quality of care and stress in parents of premature infants is higher in comparison with term infants. Counseling parents in taking care of their infants is therefore very important.

The quality of care in the first weeks has a impact on parental stress. For optimal development of the infant, parents need to be involved in the total care process at the NICU. Creating an environment, both physical and emotional, in which involvement of parents is crucial in the care for their infant, increases outcome and decreases parental stress. In addition, maternal visits are positive associated with decreased length-of-stay and rates of behavioral and emotional problems. The main predictors of lower maternal NICU visitation were the number of potential traumatic events, maternal anxiety and number of children at home.

A program was developed called VOICE: Values, Opportunities, Integration, Control and Evaluation. The program exists of 5 structured meetings in congruence with the acronym VOICE: structural interdisciplinary meetings with parents to inform and communicate with parents and to support them in decision-making and care of their infant. The aim of this VOICE program is to decrease the level of parental stress in parents. To increase the parental involvement in decision-making and care, investigators aim to implement the VOICE program and test its feasibility and impact on parents.

AIM AND OBJECTIVES The aim of the feasibility RCT is to evaluate the implementation and the effect of the VOICE program on parental stress and anxiety in the NICU.

Specifically, the objectives are:

  1. To determine the feasibility of delivering the VOICE program intervention to parents of infants GA <32 weeks admitted to the NICU A feasibility study will be conducted to collect process, resource, management and scientific data to inform the design of a larger multi-center RCT. The proposed outcome measures will be related to stress, anxiety, parent satisfaction, NICU length-of-stay, hours of parental visitation and their activities, compliance of NICU staff to the VOICE program.
  2. To explore the implementation of the VOICE program intervention with parents and healthcare professionals.

A qualitative study will explore experiences of parents who will be participating in the feasibility study and the NICU staff carrying out the intervention. This will provide information on methodological issues such as recruitment/retention, and enablers/barriers of the intervention.

METHODS Design Design of the study is a feasibility study. Since the VOICE program is a complex intervention, the MRC-framework for developing and testing complex interventions will be followed. The process from development through to implementation of a complex intervention may take a wide range of different forms.

In the developmental phase, the VOICE intervention was developed from the available evidence and experts in this field, including parents. All involved healthcare professionals have been trained. After the developmental phase, the current 'step' in this MRC framework is the feasibility and piloting phase. The study will be a mixed-method study. Specifically, the feasibility study will be conducted with RCT design and an embedded qualitative design.

Setting The NICU of the Hunan Children's Hospital is a tertiary neonatal center providing high quality care and treatment. Infants above 24 weeks gestational age (GA) are admitted and treated in this NICU. More than 5000 newborns are admitted annually. Of these infants, around 350 are born very premature, with a GA <32 weeks. These very premature infants need long-term intensive care treatment with a mean length-of-stay of 35 days. The NICU has meanwhile implemented successfully family-centered care and parent are allowed to visit their infants and become more involved in the care.

Sample size As this is a feasibility study the sample size has been determined pragmatically to address the study objectives. Investigators aim to include parents (father and/or mother) of 30 infants in the intervention group and parents of 30 infants in the standard care group.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parents of infants born < 32 weeks GA
  • Parents of infants admitted to NICU within 7days after birth
  • Parents speaking and writing Chinese.

Exclusion Criteria:

  • Parent of infants with an expected NICU length-of-stay less than 4 weeks
  • Parents of infants having a major life-threatening congenital anomaly
  • Parents of infants with a critical illness and unlikely to survive
  • Parents with an inability to participate (health, family, social, or language issues that might inhibit their ability to collaborate with the NICU staff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VOICE care

The VOICE conversations contain minimal 5 consecutive conversations with parents. The conversations are not rigid or strictly protocolized but rather focus on issues related to the situation of the admission period of the infant and the conversations should be individualized based on the parent needs. Thus, depending on the situation of the infant and the home situation of the parents.

The content of the VOICE conversations is built up based on the admission pathway of the infant. Every VOICE conversation has its own focus, and these are presented in the 5 VOICE conversation guides. Basically, every VOICE conversation is about the support of parents and infant.

The principles of the VOICE conversations are Values, Opportunities, Integration, Control and Evaluation. The VOICE program focuses on a systematic and planned communications with parents during the NICU admission and follow-up 2-4 weeks after NICU discharge.
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.
No Intervention: Standard care
Standard care is defined as the standard family centered care (FCC) practices currently implemented in the NICU. Parents are allowed to visit the NICU for 3 hours every day and provide basic care to their infant. Standard care involves meetings with the doctors three times a week and the content is mainly directed to the medical condition and treatments of the infant. No other meetings between parents and doctors/nurses exists. The FCC principles implicate that parents and NICU staff work closely together on the NICU. This also involves unscheduled information and communication contact moments where short questions of parents will be addressed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Hospital Anxiety and Depression before and after intervention
Time Frame: Time Frame of measurement : T1 = Baseline pre-intervention (first week of admission) , T2 = After intervention (4 weeks after discharge)
Hospital Anxiety and Depression scale is a 14-item scale measuring hospital anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Each subscale has a score ranging from 0 to 21. Items are rated on a 4-point Likert scale, ranging from 0-3, generating a scale range of 0-42 points, with higher scores representing greater symptom severity. Score of 0-7 indicates normal levels of anxiety and depression; 8-10 indicate borderline abnormal anxiety and depression levels, and 11-21 suggest abnormal levels of anxiety and depression.
Time Frame of measurement : T1 = Baseline pre-intervention (first week of admission) , T2 = After intervention (4 weeks after discharge)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postnatal Depression
Time Frame: Measure time point: After invervention(4 weeks after discharge)
Edinburgh Postnatal Depression Scale usually be completed in less than 5 minutes. Responses are scored 0, 1, 2, or 3 according to increased severity of the symptom. The total score is determined by adding together the scores for each of the 10 items. Cut-off scores ranged from 9 to 13 points and with higher scores representing greater symptom severity.
Measure time point: After invervention(4 weeks after discharge)
Parent satisfaction
Time Frame: Measure time point: After invervention(4 weeks after discharge)
Parent satisfaction measured by the Empowerment of Parents in the Intensive Care (EMPATHIC-30) scale.The EMPATHIC-30 consist of 30 statement measuring parent satisfaction and experience. The scores of the statement are on a scale of 1-6 (from certainly yes to certainly no). Scores are presented in mean and SD values on statement level and domain level. Higher scores represent greater satisfaction.
Measure time point: After invervention(4 weeks after discharge)
Length-of-stay in the NICU
Time Frame: Measure time point: After invervention(4 weeks after discharge)
The length-of-stay in the NICU will be collected.
Measure time point: After invervention(4 weeks after discharge)
Hours of parental daily visitation and their activities
Time Frame: Daily during intervention
The number of hours of parental visitation and their activities will be collected.
Daily during intervention
Weight gain during hospitalization
Time Frame: T1 = at admission ,T2 = at discharge
Weight at admission and weight at discharge will be collected.
T1 = at admission ,T2 = at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Children's Hospital

Investigators

  • Principal Investigator: Xiao-ming Peng, Hunan Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

April 30, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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