Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06048783
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-08-24
Brief Title:
Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Feasibility and Preliminary Effects of a Spiritual Care Strategy on Psychological Disorders in Critically Ill Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 chaplainpriest 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
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 peoples 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 chaplainpriest 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
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 chaplainpriest 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None