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

NCT06048783 | Not Yet Recruiting

• 1 other identifier: 220111005
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychological Disorder; Critical Illness

Keywords

Post traumatic stress disorder; Intensive Care; Critically ill patients; Spiritual Care

Outcome Measures

Primary Outcomes (4)

• Rate of enrollment

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

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

• Attendance Rate

  Proportion of participants who attend all three intervention sessions

  2 weeks

• Follow-up rate

  Proportion of patients who attend all follow-up assessment

  3 and 6 months post ICU discharge

• Intervention Satisfaction Survey

  Satisfaction of the intervened group with the spiritual care will be assessed by a satisfaction survey.

  1-2 weeks and 3 months after the last session

Secondary Outcomes (4)

• Intervention Satisfaction Survey

  1-2 weeks after the last session

• Post traumatic syndrome assessed by the Revised impact event scale (IES-R)

  3 and 6 months post ICU discharge

• Anxiety and depression symptoms assessed by Hospital Anxiety and Depression Scale (HADS)

  3 and 6 months post ICU discharge

• Perceptions of patients, volunteers and research team about the intervention, its components, training and recommendations, and difficulties encountered

  2-3 weeks after the last session

Study Arms (2)

Program of systematic and periodic spiritual accompaniment and care

EXPERIMENTAL

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.

Behavioral: Program of systematic and periodic spiritual accompaniment and care

Standard Care

NO INTERVENTION

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.

Interventions

Program of systematic and periodic spiritual accompaniment and care BEHAVIORAL

Systematic and periodic spiritual accompaniment and care

Program of systematic and periodic spiritual accompaniment and care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who has had at least 72 hours of Invasive Mechanical Ventilation
• Patient currently in ICU
• Glasgow 15 at the moment of the screening

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Related Publications (1)

• Repetto P, Ruiz C, Rojas V, Olivares P, Bakker J, Alegria L. Spiritual care for prevention of psychological disorders in critically ill patients: study protocol of a feasibility randomised controlled pilot trial. BMJ Open. 2025 Apr 3;15(4):e084914. doi: 10.1136/bmjopen-2024-084914.

  PMID: 40180407 DERIVED

MeSH Terms

Conditions

Mental Disorders; Critical Illness; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Paula Repetto, PhD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyla Alegria, MSc

CONTACT

+56223549024; lmalegri@uc.cl

Paula Repetto, PhD

CONTACT

prepetto@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 21, 2023
• Study Start: January 15, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share