VOICE Study in China 'Towards a Partnership Between Parents of Very Premature Infants and Healthcare Professionals'
NCT ID: NCT05385198
Last Updated: 2022-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-06-01
2023-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of a Structured Maternal Voice Program on Premature Infant Responses and Maternal-Infant Attachment in the Neonatal Intensive Care Unit
NCT06839534
NHFOV as Primary Support in Very Preterm Infants With RDS
NCT05141435
Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants
NCT06635473
Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment
NCT04932044
The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants
NCT05503238
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Parents of infants admitted to NICU within 7days after birth
* Parents speaking and writing Chinese.
Exclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hunan Children's Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiao-ming Peng
Role: PRINCIPAL_INVESTIGATOR
Hunan Children's Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Alkozei A, McMahon E, Lahav A. Stress levels and depressive symptoms in NICU mothers in the early postpartum period. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1738-43. doi: 10.3109/14767058.2014.942626. Epub 2014 Jul 30.
Ayers S, Joseph S, McKenzie-McHarg K, Slade P, Wijma K. Post-traumatic stress disorder following childbirth: current issues and recommendations for future research. J Psychosom Obstet Gynaecol. 2008 Dec;29(4):240-50. doi: 10.1080/01674820802034631.
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
Davis L, Edwards H, Mohay H, Wollin J. The impact of very premature birth on the psychological health of mothers. Early Hum Dev. 2003 Aug;73(1-2):61-70. doi: 10.1016/s0378-3782(03)00073-2.
Engelhard IM, van den Hout MA, Schouten EG. Neuroticism and low educational level predict the risk of posttraumatic stress disorder in women after miscarriage or stillbirth. Gen Hosp Psychiatry. 2006 Sep-Oct;28(5):414-7. doi: 10.1016/j.genhosppsych.2006.07.001.
Engelhard IM, van Rij M, Boullart I, Ekhart TH, Spaanderman ME, van den Hout MA, Peeters LL. Posttraumatic stress disorder after pre-eclampsia: an exploratory study. Gen Hosp Psychiatry. 2002 Jul-Aug;24(4):260-4. doi: 10.1016/s0163-8343(02)00189-5.
Gonya J, Martin E, McClead R, Nelin L, Shepherd E. Empowerment programme for parents of extremely premature infants significantly reduced length of stay and readmission rates. Acta Paediatr. 2014 Jul;103(7):727-31. doi: 10.1111/apa.12669.
Greene MM, Rossman B, Patra K, Kratovil A, Khan S, Meier PP. Maternal psychological distress and visitation to the neonatal intensive care unit. Acta Paediatr. 2015 Jul;104(7):e306-13. doi: 10.1111/apa.12975. Epub 2015 Feb 27.
Helder OK, Verweij JC, van Staa A. Transition from neonatal intensive care unit to special care nurseries: experiences of parents and nurses. Pediatr Crit Care Med. 2012 May;13(3):305-11. doi: 10.1097/PCC.0b013e3182257a39.
Jiang S, Warre R, Qiu X, O'Brien K, Lee SK. Parents as practitioners in preterm care. Early Hum Dev. 2014 Nov;90(11):781-5. doi: 10.1016/j.earlhumdev.2014.08.019. Epub 2014 Sep 20.
Koren, P. E., DeChillo, N., & Friesen, B. J. (1992). Measuring empowerment in families whose children have emotional disabilities: A brief questionnaire. Rehabilitation Psychology, 37(4), 305-321.
Latour JM, Duivenvoorden HJ, Hazelzet JA, van Goudoever JB. Development and validation of a neonatal intensive care parent satisfaction instrument. Pediatr Crit Care Med. 2012 Sep;13(5):554-9. doi: 10.1097/PCC.0b013e318238b80a.
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.
Melnyk BM, Feinstein NF. Reducing hospital expenditures with the COPE (Creating Opportunities for Parent Empowerment) program for parents and premature infants: an analysis of direct healthcare neonatal intensive care unit costs and savings. Nurs Adm Q. 2009 Jan-Mar;33(1):32-7. doi: 10.1097/01.NAQ.0000343346.47795.13.
O'Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK. Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia. BMC Pediatr. 2015 Dec 15;15:210. doi: 10.1186/s12887-015-0527-0.
Schappin R, Wijnroks L, Uniken Venema MM, Jongmans MJ. Rethinking stress in parents of preterm infants: a meta-analysis. PLoS One. 2013;8(2):e54992. doi: 10.1371/journal.pone.0054992. Epub 2013 Feb 6.
Stowe ZN, Nemeroff CB. Women at risk for postpartum-onset major depression. Am J Obstet Gynecol. 1995 Aug;173(2):639-45. doi: 10.1016/0002-9378(95)90296-1.
Weis J, Zoffmann V, Egerod I. Improved nurse-parent communication in neonatal intensive care unit: evaluation and adjustment of an implementation strategy. J Clin Nurs. 2014 Dec;23(23-24):3478-89. doi: 10.1111/jocn.12599. Epub 2014 Apr 3.
White T , Matthey S , Boyd K , et al. Postnatal depression and post-traumatic stress after childbirth: Prevalence, course and co-occurrence[J]. Journal of Reproductive & Infant Psychology, 2006, 24(2):107-120.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HN06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.