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Completed

NCT Number: NCT04856332

Study Evaluating the Parent-child Relationship During the Hospitalisation of a Parent in Long-term Protective Isolation

The intensive treatments of certain cancers and haemopathies require the implementation of a protective isolation from external micro-organisms for a period of several weeks. This isolation implies a limitation of visitors and sometimes prohibits access to young children. This raises questions concerning the maintenance of family links, and in particular the parent-child relationship as well as the psychological and emotional isolation of hospitalised patients and the resulting psychological effects.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Lyon Sud, Lyon, France

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About this study

Telepresence robots are increasingly used as a means of remote communications, especially for teleconsultations and/or access to various public services (cultural events, education, etc.). In the context of long-term hospitalisation, they can be used for various purposes, such as access to cultural events, university activities, contact with patient's home and maintenance of family links. Some studies have analyzed the use of these robots and their effects in academic settings or the suitability of their use with elderly populations for continuing care.

To our knowledge, no study has evaluated the interest for the parent-child relationship of the use of a telepresence robot during the hospitalisation in protective isolation for a long period of a patient with young child(ren).

We propose to conduct this observational, multi-center prospective study aiming at evaluating the parent-child relationship following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥ 18
  • Patient with at least one child aged 15 or under
  • Pathology requiring a prolonged hospitalization in protective isolation
  • Consent dated and signed

Exclusion criteria

  • Impaired cognitive functions
  • Performance Status -Eastern Cooperative Oncology Group (PS-ECOG) = 4
  • Difficulties in speaking and understanding French
  • Patient under guardianship or curatorship

Treatment and study plan

Telepresence robot installed at child's home during parent's hospitalisation

Other

Telepresence robot installed at child's home during parent's hospitalisation in long term protective isolation for maintaining parent-child ink (only children aged 15 years or less are concerned)

Primary outcomes

  1. Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation

    Time frame: Through study completion, an average of 3 months

    Observation of communications between the hospitalised patient and his/her chid(children) by a specialist in human and social sciences

  2. Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation

    Time frame: Through study completion, an average of 3 months

    Interview with the hospitalised patient (parent) by a specialist in human and social sciences

Secondary outcomes

  1. Evaluation of the experience linked to the robot availability on the concerned persons (patient, children, person on charge of children)

    Time frame: Through study completion, an average of 3 months

    Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences

  2. Evaluation of patient's satisfaction

    Time frame: Through study completion, an average of 3 months

    Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences

  3. Evaluation of the impact of robot use on patient's coping strategies (adaptation and adjustment to illness and hospitalisation)

    Time frame: Through study completion, an average of 3 months

    Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences

  4. Evaluation of patient's experience of hospitalisation

    Time frame: Through study completion, an average of 3 months

    Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences

  5. Evaluation of the impact of the robot's presence at home on the children and the person in charge of the children during patient's hospitalisation

    Time frame: Through study completion, an average of 3 months

    Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

VIK-e2 - Observational, Multicenter Prospective Study Evaluating Parent-child Relationship with the Setting Up of a Mobile Telepresence Robot for Patients with Children Aged 15 Years or Less and Hospitalised in Long-term Protective Isolation

Acronym: VIK-e2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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