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

NCT05385198 | Unknown

• 1 other identifier: HN06
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change of Hospital Anxiety and Depression before and after intervention

  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 Outcomes (5)

• Postnatal Depression

  Measure time point: After invervention(4 weeks after discharge)

• Parent satisfaction

  Measure time point: After invervention(4 weeks after discharge)

• Length-of-stay in the NICU

  Measure time point: After invervention(4 weeks after discharge)

• Hours of parental daily visitation and their activities

  Daily during intervention

• Weight gain during hospitalization

  T1 = at admission ,T2 = at discharge

Study Arms (2)

VOICE care

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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.

Interventions

VOICE care BEHAVIORAL

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.

VOICE care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunan Children's Hospital: lead

Related Publications (21)

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  BACKGROUND

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  PMID: 22460771 BACKGROUND

• Latour JM, Hazelzet JA, Duivenvoorden HJ, van Goudoever JB. Perceptions of parents, nurses, and physicians on neonatal intensive care practices. J Pediatr. 2010 Aug;157(2):215-220.e3. doi: 10.1016/j.jpeds.2010.02.009. Epub 2010 Mar 31.

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  BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.

  PMID: 27965879 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Xiao-ming Peng

  Hunan Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zhuang

CONTACT

+86-177-0843-9719; 121427059@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 23, 2022
• Study Start: June 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: January 31, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share