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Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients

Primary Purpose

Psychological Disorder, Critical Illness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Program of systematic and periodic spiritual accompaniment and care
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychological Disorder focused on measuring Post traumatic stress disorder, Intensive Care, Critically ill patients, Spiritual Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient who has had at least 72 hours of Invasive Mechanical Ventilation Patient currently in ICU Glasgow 15 at the moment of the screening Exclusion Criteria: Patient who required mechanical ventilation in another episode of hospitalization in the 2 months before screening. Patients with primary neurological or neurosurgical disease. Presence of mental or intellectual disability prior to hospitalization or communication/language barriers. Pre-existing comorbidity with a life expectancy not exceeding 6 months (eg, metastatic cancer). Readmission to the ICU (patients can only be included if they are on their first ICU admission of the present hospitalization). No fixed address for follow-up. Patients with moderate to severe visual or hearing impairment. Early limitation of therapeutic effort.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Program of systematic and periodic spiritual accompaniment and care

    Standard Care

    Arm Description

    A minimum of 3 sessions of spiritual accompaniment by trained volunteers, considering a 1:1 ratio (patient:companion). The topics that will be proposed during the sessions are: sense of suffering, uncertainty, death, life after life, ideas about healing, forgiveness and guilt, etc. In addition, the spiritual needs of the participants will be explored through an instrument specially designed for this purpose and culturally adapted in Chile (FICA). The spiritual accompaniment sessions will be implemented preferably at a distance, using zoom or video call.

    It correspond to spiritual care currently offered by the hospital. This consists of the possibility of being assisted by a Catholic priest or being contacted by pastors from Protestant churches.

    Outcomes

    Primary Outcome Measures

    Rate of enrollment
    Proportion of eligible patients that are consented and enrolled in the trial
    Attendance Rate
    Proportion of participants who attend all three intervention sessions
    Follow-up rate
    Proportion of patients who attend all follow-up assessment
    Intervention Satisfaction Survey
    Satisfaction of the intervened group with the spiritual care will be assessed by a satisfaction survey.

    Secondary Outcome Measures

    Intervention Satisfaction Survey
    Volunteer satisfaction with the spiritual care and accompaniment intervention will be assessed by a satisfaction survey.
    Post traumatic syndrome assessed by the Revised impact event scale (IES-R)
    The post traumatic syndrome will be evaluated thanks to the chilean version of the Revised impact event scale (IES-R) giving a score going from 0 to 88. This scale has a score from 0 to 88, defining a post-traumatic stress disorder with a score higher than 43.
    Anxiety and depression symptoms assessed by Hospital Anxiety and Depression Scale (HADS)
    The HADS is a 14-item(1 - 4 points) measure designed to assess anxiety and depression symptoms in medical patients. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores higher than 11 on either scale indicate a definitive case.
    Perceptions of patients, volunteers and research team about the intervention, its components, training and recommendations, and difficulties encountered
    At the end of the study, three focus group will be held with the participants, volunteers and the research team. In the focus group, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Thematic analysis method will be used in the evaluation of the data.

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Pontificia Universidad Catolica de Chile
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06048783
    Brief Title
    Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients
    Official Title
    Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    August 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pontificia Universidad Catolica de Chile

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Studies in hospitalized patients have shown that a large percentage of them consider religion or spirituality to be an important factor in enabling them to cope with a serious illness. Studies conducted in the ICU, have shown that spiritual care from a chaplain/priest is associated with increased satisfaction in family members of critically ill patients, however, the focus has traditionally been on offering support to family members and not to patients. Interventions for critically ill patients have mostly been implemented by chaplains or a member of the health care team, primarily nurses. Although these studies show promising results in terms of quality of life, they mostly reflect the perspective of the health teams and not that of the patients, they are not evaluated with standardized instruments and, in general, they are not standardized strategies. Given that this will be one of the first studies with patients who received care in the ICU, it is proposed to conduct a pilot and feasibility study to gather lessons to implement a larger study. Studies of this type place greater emphasis on evaluating the feasibility of implementing the intervention and therefore this study will seek to: (1) evaluate the feasibility of implementing the intervention in a hospital setting, including participant recruitment procedures; (2) evaluate how the intervention, format and manner of implementation is received by participants; (3) preliminarily evaluate the impact on psychological symptomatology associated with PICS at the end of the intervention, at 3 and 6 months post-intervention. Showing the impact of spiritual care on health outcomes of individuals, through studies such as this one, may contribute to a paradigm shift from a biomedical perspective to a holistic view of ICU patients. Although the technological and advanced life support offered by the ICU is essential for critical patients, but survival of a severe disease without a good quality of life makes it necessary to seek strategies to improve this problem, which undoubtedly requires a comprehensive approach to the person, through medical-physiological care and spiritual care.
    Detailed Description
    Many patients who survive a critical illness suffer physical, psychological and cognitive problems, negatively impacting their quality of life, which has been termed Post-ICU Syndrome (PICS). Some studies have reported a residual effect several months after discharge from the ICU, affecting people's quality of life and functionality. Among the psychological symptoms of PICS are described symptoms of depression, anxiety and post-traumatic stress disorder (PTSD). It is estimated that at least 50% of ICU survivors will present psychological symptoms of PICS at discharge and other studies report that a quarter of survivors present PTSD symptoms one year after discharge from the ICU. Spirituality should be an essential element of health care, as it is part of the essence of being human. International accreditation associations and scientific societies suggest incorporating spiritual care into the usual standards of care. Studies of hospitalized patients have shown that a large percentage of patients consider religion or spirituality to be an important factor in enabling them to cope with serious illness. And although previous studies have shown that chaplain/priest care is associated with increased satisfaction in family members of critically ill patients, the focus has traditionally been on offering support to family members and not to patients. However, there is a growing recognition of the need for a comprehensive approach in health care to provide spiritual support to ICU patients that is evaluated and contributes to improving the quality of life of these individuals. On the other hand, showing the impact of spiritual care on health outcomes of individuals, through studies such as this one, can contribute to a paradigm shift from a biomedical perspective to a holistic view of ICU patients. The technological and advanced life support offered by the ICU is essential for critically ill patients, but the survival of a severe disease without a good quality of life makes it necessary to seek strategies to improve this problem, which undoubtedly requires a comprehensive approach to the person, through medical-physiological care and spiritual care. The proposed design aims to evaluate the feasibility of implementing a spiritual accompaniment intervention for patients who received care in the ICU, and to begin to implement it during hospitalization. This will provide information regarding the feasibility of implementing an intervention of this type in this context, offering it during hospitalization and its remote implementation process, once the patient is discharged. Considering that these studies work with small samples, it is not necessary to estimate the sample calculation. However, in order to obtain some preliminary results of the effect of the intervention, a sample of 15 people per group will be recruited and followed up until 6 months after discharge, which will allow us to evaluate changes over time in PICS symptoms. It is proposed that the intervention will begin during hospitalization, so that it will have a preventive nature and help mitigate the impact of ICU hospitalization on the development of mental health symptoms in patients. Participants will be randomly assigned to groups and will be evaluated considering intention to treat. On the other hand, gathering the perspective of volunteers, patients and research support team will provide us with inputs to improve the intervention and the best way to implement it.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychological Disorder, Critical Illness
    Keywords
    Post traumatic stress disorder, Intensive Care, Critically ill patients, Spiritual Care

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Program of systematic and periodic spiritual accompaniment and care
    Arm Type
    Experimental
    Arm Description
    A minimum of 3 sessions of spiritual accompaniment by trained volunteers, considering a 1:1 ratio (patient:companion). The topics that will be proposed during the sessions are: sense of suffering, uncertainty, death, life after life, ideas about healing, forgiveness and guilt, etc. In addition, the spiritual needs of the participants will be explored through an instrument specially designed for this purpose and culturally adapted in Chile (FICA). The spiritual accompaniment sessions will be implemented preferably at a distance, using zoom or video call.
    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    It correspond to spiritual care currently offered by the hospital. This consists of the possibility of being assisted by a Catholic priest or being contacted by pastors from Protestant churches.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Program of systematic and periodic spiritual accompaniment and care
    Intervention Description
    Systematic and periodic spiritual accompaniment and care
    Primary Outcome Measure Information:
    Title
    Rate of enrollment
    Description
    Proportion of eligible patients that are consented and enrolled in the trial
    Time Frame
    From recruitment to enrollment (i.e. up to 120 days)
    Title
    Attendance Rate
    Description
    Proportion of participants who attend all three intervention sessions
    Time Frame
    2 weeks
    Title
    Follow-up rate
    Description
    Proportion of patients who attend all follow-up assessment
    Time Frame
    3 and 6 months post ICU discharge
    Title
    Intervention Satisfaction Survey
    Description
    Satisfaction of the intervened group with the spiritual care will be assessed by a satisfaction survey.
    Time Frame
    1-2 weeks and 3 months after the last session
    Secondary Outcome Measure Information:
    Title
    Intervention Satisfaction Survey
    Description
    Volunteer satisfaction with the spiritual care and accompaniment intervention will be assessed by a satisfaction survey.
    Time Frame
    1-2 weeks after the last session
    Title
    Post traumatic syndrome assessed by the Revised impact event scale (IES-R)
    Description
    The post traumatic syndrome will be evaluated thanks to the chilean version of the Revised impact event scale (IES-R) giving a score going from 0 to 88. This scale has a score from 0 to 88, defining a post-traumatic stress disorder with a score higher than 43.
    Time Frame
    3 and 6 months post ICU discharge
    Title
    Anxiety and depression symptoms assessed by Hospital Anxiety and Depression Scale (HADS)
    Description
    The HADS is a 14-item(1 - 4 points) measure designed to assess anxiety and depression symptoms in medical patients. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores higher than 11 on either scale indicate a definitive case.
    Time Frame
    3 and 6 months post ICU discharge
    Title
    Perceptions of patients, volunteers and research team about the intervention, its components, training and recommendations, and difficulties encountered
    Description
    At the end of the study, three focus group will be held with the participants, volunteers and the research team. In the focus group, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Thematic analysis method will be used in the evaluation of the data.
    Time Frame
    2-3 weeks after the last session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient who has had at least 72 hours of Invasive Mechanical Ventilation Patient currently in ICU Glasgow 15 at the moment of the screening Exclusion Criteria: Patient who required mechanical ventilation in another episode of hospitalization in the 2 months before screening. Patients with primary neurological or neurosurgical disease. Presence of mental or intellectual disability prior to hospitalization or communication/language barriers. Pre-existing comorbidity with a life expectancy not exceeding 6 months (eg, metastatic cancer). Readmission to the ICU (patients can only be included if they are on their first ICU admission of the present hospitalization). No fixed address for follow-up. Patients with moderate to severe visual or hearing impairment. Early limitation of therapeutic effort.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leyla Alegria, MSc
    Phone
    +56223549024
    Email
    lmalegri@uc.cl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paula Repetto, PhD
    Email
    prepetto@uc.cl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paula Repetto, PhD
    Organizational Affiliation
    Pontificia Universidad Catolica de Chile
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients

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