Parents Clinical Trial
— VOICEOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | January 31, 2023 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hunan Children's Hospital |
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Postnatal Depression | 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) | |
Secondary | Parent satisfaction | 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) | |
Secondary | Length-of-stay in the NICU | The length-of-stay in the NICU will be collected. | Measure time point: After invervention(4 weeks after discharge) | |
Secondary | Hours of parental daily visitation and their activities | The number of hours of parental visitation and their activities will be collected. | Daily during intervention | |
Secondary | Weight gain during hospitalization | Weight at admission and weight at discharge will be collected. | T1 = at admission ,T2 = at discharge |
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