Impact of Psychoeducation in Quality of Life of Parents With Children With Congenital Heart Defects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-07

Study Completion Date

2020-02-28

Brief Summary

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Congenital heart defects (CHD) are the most common congenital malformations. Despite the progress made in the last decades in diagnosis and treatment, CHD continues to be associated with significant morbidity and mortality. Several studies have shown a reduction in the quality of life (QoL) of parents of children with CHD, which may affect children too. The main research aim is to assess and to understand the impact of a psychoeducational intervention in QoL of parents with newborns with CHD.

We are including parents of inpatient newborns in Neonatal Intensive Care Unit (NICU) of UAG da Mulher e Criança - Centro Hospitalar Universitário de São João (CHUSJ) with the diagnosis of non-syndromic CHD, between March 2019 and February 2020. We also included parents of newborns born at CHUSJ with the diagnosis of non-syndromic CHD, not admited in NICU, between September 2019 and February 2020. The inclusion criteria are: I) parents of newborns (up to 28 days) with the diagnosis of non- syndromic CHD; II) newborns hospitalized in CHUSJ; III) parents aged ≥ 18 years. Parents of newborns with other important co-morbidities associated with CHD and those who do not have good understanding and expression in Portuguese will be excluded.

Parents will be divided in 2 study groups: INTERVENTION group (I) and CONTROL group (C). Group I will receive a psychoeducational intervention in addition to the usual routines of the Service. Group C will receive the usual routines of the Service. The psychoeducational intervention, which consists of 2 sessions lasting 90 minutes each one, will be performed as soon as possible after inclusion in the study. Participants will be evaluated in three moments: M1 beginning of the study; M2 4 weeks after the intervention (I) or after enrollment (C) and M3 16 weeks after intervention/enrollment. The primary outcome will be parental QoL, which will be evaluated through the World Health Organization Quality of Life-Bref (WHOQOL-Bref). The family impact and the perception of positive contributions will be secondary outcomes. These outcome variables will be assessed by the Impact on Family Scale and the Positive Contributions Scale - Kansas Inventory of Parental Perceptions, respectively. A semi-structured interview will be performed after all quantitative data have been collected.

The authors expect to find an increase of QoL and positive contributions and a decrease of family impact in the intervention group comparatively to the control group.

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Detailed Description

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Conditions

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Congenital Heart Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parents will be divided in 2 study groups: INTERVENTION group (I) and CONTROL group (C).

Group I will receive a psychoeducational intervention in addition to the usual routines of the Service. Group C will receive the usual routines of the Service. The intervention will be performed as soon as possible after inclusion in the study.

Participants will be evaluated in 3 moments: M1 beginning of the study; M2 4 weeks after the intervention (I) or after enrollment (C) and M3 16 weeks after intervention/enrollment. The primary outcome will be parental QoL, which will be evaluated through the WHOQOL-Bref. The family impact and the perception of positive contributions will be secondary outcomes. These outcome variables will be assessed by the Impact on Family Scale and the Positive Contributions Scale - Kansas Inventory of Parental Perceptions, respectively. A semi-structured interview will be performed after all quantitative data have been collected.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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INTERVENTION group (I)

Group I will be composed by parents of children with the diagnosis of CHD who will receive a psychoeducational intervention plus usual routines of the Service.

Group Type EXPERIMENTAL

Psychoeducational intervention

Intervention Type BEHAVIORAL

The intervention, prepared by a multidisciplinary team, will consist of two 90 minutes collective sessions (max. 8 families). Sessions will consist of lectures, group discussion and relaxation. The program includes content on the effects of a diagnosis of a congenital anomaly on a child in the parents and in the family, stages of mourning, adaptation process, coping strategies, legislative framework and social protection. This is a non-specific intervention for CHD, where the main focus is the diagnosis of a congenital anomaly.

In second session, written support material will be distributed. Participants will be asked to practice relaxation in the next 4 weeks.

CONTROL group (C)

Group C will be composed by parents of children with the diagnosis of CHD who will receive the usual routines of the Service. After completing the data collection, the possibility of receiving the psychoeducational intervention under study will be offered to this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychoeducational intervention

The intervention, prepared by a multidisciplinary team, will consist of two 90 minutes collective sessions (max. 8 families). Sessions will consist of lectures, group discussion and relaxation. The program includes content on the effects of a diagnosis of a congenital anomaly on a child in the parents and in the family, stages of mourning, adaptation process, coping strategies, legislative framework and social protection. This is a non-specific intervention for CHD, where the main focus is the diagnosis of a congenital anomaly.

In second session, written support material will be distributed. Participants will be asked to practice relaxation in the next 4 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parents of newborns (up to 28 days) with the diagnosis of non-syndromic CHD;
* Newborns hospitalized in CHUSJ;
* Parents aged ≥ 18 years.

Exclusion Criteria

* Parents of newborns with other important comorbidities associated with CHD;
* Parents who do not have good understanding and expression in Portuguese.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marisa Rodrigues, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Investigação em Tecnologias e Serviços de Saúde; Faculdade de Medicina da Universidade do Porto; Centro Hospitalar Universitário de São João

Maria Emília Areias, PhD

Role: STUDY_CHAIR

Instituto Universitário de Ciências da Saúde da Cooperativa do Ensino Superior, Politécnico e Universitário; Unidade de Investigação e Desenvolvimento Cardiovascular do Porto

José Carlos Areias, PhD

Role: STUDY_CHAIR

Faculdade de Medicina da Universidade do Porto; Unidade de Investigação e Desenvolvimento Cardiovascular do Porto

Pedro Pereira Rodrigues, PhD

Role: STUDY_CHAIR

Centro de Investigação em Tecnologias e Serviços de Saúde; Departamento de Medicina da Comunidade Informação e Decisão em Saúde; Faculdade de Medicina da Universidade do Porto

Luís Filipe Azevedo, PhD

Role: STUDY_CHAIR

Centro de Investigação em Tecnologias e Serviços de Saúde; Departamento de Medicina da Comunidade Informação e Decisão em Saúde; Faculdade de Medicina da Universidade do Porto