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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPontificia Universidad Catolica de Chile

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient who has had at least 72 hours of Invasive Mechanical Ventilation

Patient currently in ICU

Glasgow 15 at the moment of the screening

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Program of systematic and periodic spiritual accompaniment and care

    Behavioral

    Systematic and periodic spiritual accompaniment and care

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Program of systematic and periodic spiritual accompaniment and careExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of enrollment

Proportion of eligible patients that are consented and enrolled in the trial

Time frame
From recruitment to enrollment (i.e. up to 120 days)
2

Attendance Rate

Proportion of participants who attend all three intervention sessions

Time frame
2 weeks
3

Follow-up rate

Proportion of patients who attend all follow-up assessment

Time frame
3 and 6 months post ICU discharge
4

Intervention Satisfaction Survey

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 outcomes

1

Intervention Satisfaction Survey

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
2

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.

Time frame
3 and 6 months post ICU discharge
3

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.

Time frame
3 and 6 months post ICU discharge
4

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.

Time frame
2-3 weeks after the last session

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: