Intervention in Spirituality at the End of Life. The Kibo Protocol

Palliative Care Clinical Trial

Official title:

Intervention in Spirituality at the End of Life. The Kibo Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995095
• Other study ID #: H1447334931417
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: March 31, 2019

Study information

• Verified date: June 2019
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This work aims to study the benefits that the therapeutic interview Kibo in palliative care patients can have for spirituality.

A parallel randomized controlled trial of two groups was performed. Information was collected on 60 palliative care patients during the moments before and after the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. To be 18 or more years of age.

2. Being in advanced or terminal disease phase (following World Health Organization criteria).

3. To have preserved cognitive capacity.

4. To have signed the informed consent.

Exclusion Criteria:

a) Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.

Related Conditions & MeSH terms

• Palliative Care

Intervention

Other:
• Therapeutic interview: kibo protocol
The kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life.

Locations

Country	Name	City	State
Spain	Universitat de València	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Sociedad Española de Cuidados Paliativos SECPAL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the dimension of spirituality (PRE and POST measures)	This variable was assessed with the Spirituality questionnaire from the Spanish Society of Palliative Care (SECPAL). This questionnaire contains 8 items, and it provides scores from 0 to 32, where higher values represent a better outcome.; In order to observe the change in the dimension of spirituality, it was measured at in two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.; Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out.; Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).	Baseline up to 4 weeks
Secondary	Change in resilience (PRE and POST measures)	This variable was assessed with the Brief Resilient Coping Scale (BRCS). This scale contains 4 items, and it provides scores from 4 to 20, where higher values represent a better outcome.; In order to observe the change in the dimension of resilience, it was measured at in two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.; Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out.; Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).	Baseline up to 4 weeks
Secondary	Change in demoralization (PRE and POST measures)	This variable was assessed with the Short Demoralization Scale (SDS). This scale contains 5 items, and it provides scores from 0 to 20, where lower values represent a better outcome.; In order to observe the change in the dimension of demoralization, it was measured at in two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed.; Second measurement: POST. Up to 4 weeks after the first measurement, the second measurement of the same variable was carried out.; Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received usual psychological attention plus attention of spiritual needs following the Kibo protocol (intervention).	Baseline up to 4 weeks