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Completed

NCT Number: NCT03995095

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

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.

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Key information

Conditions

Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat de València

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be 18 or more years of age.
  • Being in advanced or terminal disease phase (following World Health Organization criteria).
  • To have preserved cognitive capacity.
  • 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.

Treatment and study plan

Therapeutic interview: kibo protocol

Other

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

Primary outcomes

  1. Change in the dimension of spirituality (PRE and POST measures)

    Time frame: Baseline up to 4 weeks

    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).

Secondary outcomes

  1. Change in resilience (PRE and POST measures)

    Time frame: Baseline up to 4 weeks

    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).

  2. Change in demoralization (PRE and POST measures)

    Time frame: Baseline up to 4 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Sociedad Española de Cuidados Paliativos SECPAL

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 21, 2019
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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