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A MEDITATION PROGRAM IN HIGH-BURDEN INFORMAL CAREGIVERS

Primary Purpose

Caregivers Burnout

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Meditation.
Scientific descriptions about meditation.
Sponsored by
Consuelo Lourdes Díaz Rodríguez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caregivers Burnout

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • People who care for a dependent family member or close relative and live with him/her in the same home for at least two years with a caregiver burden of more than 55 points in Zarit Burden Scale.

Exclusion Criteria:

  • People that have previous experience in mind body practices or cardiovascular diseases.

Sites / Locations

  • Lourdes Díaz Rodríguez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Meditation program

Scientific descriptions about meditation

Arm Description

The experimental group participated in the Meditation program during one month, eight sessions with a total of sixteen hours.

The control group received scientific descriptions about meditation.

Outcomes

Primary Outcome Measures

Change from Baseline in Happiness on the Lima happiness questionnaire after 1 month
Lima happiness questionnaire: Validated self-administered questionnaire consisting of 27 items, integrated into 4 subscales (Positive sense of life, Satisfaction with life, Personal fulfillment and Joy of life), which refer to the level of happiness or satisfaction that the person has with respect to his life. The respondent may be: (1) Strongly agree, (2) Agree, (3) Neither agree nor disagree, (4) Disagree or (5) Strongly disagree, with any question that arises. According to the total score there are 5 levels of happiness: from 27-87: very low happiness, 88-95: low, 96-110: medium, 111-118: high, 119-135: very high.
Change from Baseline in Anxiety and Depression on the Hospital Anxiety and Depression Scale (HADS) after 1 month
Validated self-administered instrument for outpatients that advises on the possible presence of anxiety and depression in any non-psychiatric medical consultation. Describe how the patient feels affective and emotionally during the last week. It has 14 items, 7 for each subscale with a scale similar to four points (from 0 to 3). Lower scores reflect better outcomes.
Change from Baseline in Heart rate and Heart rate variability after 1 month
We measured short-term HRV using an accepted method in order to assess the cardiovascular balance (Kappussami 2020). We asked participants to lie in a supine position for 10 min of rest with normal breathing (following a metronome at 0.2 Hz) and no external stimulation in a quiet room with a temperature of 22-25 °C.
Change from Baseline in Blood pressure/heart rate after 1 month
We measured blood pressure and heart rate before and after the treatment session using an Omron HEM-7320-Z validated automatic oscillometer.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2020
Last Updated
September 24, 2020
Sponsor
Consuelo Lourdes Díaz Rodríguez
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1. Study Identification

Unique Protocol Identification Number
NCT04570826
Brief Title
A MEDITATION PROGRAM IN HIGH-BURDEN INFORMAL CAREGIVERS
Official Title
EFFECTS OF A MEDITATION PROGRAM ON THE QUALITY OF LIFE IN HIGH-BURDEN INFORMAL CAREGIVERS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Consuelo Lourdes Díaz Rodríguez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present study was to investigate in high burden caregivers the effects of a face-to-face meditation program during four weeks (16 hours) on physiological parameters, psychological state and vagal nerve activity comparing with a control group.
Detailed Description
A non-randomized repeated-measures controlled clinical trial was conducted with convenience allocation of participants into intervention (n = 18) or control group (n = 17). Due to ethical reasons, it was not possible to randomize the patients. The investigators invited from different associations in Granada city and its province through word and mouth or by telephone to 45 volunteer informal caregivers. 40 of them enrolled in this study but only 37 finalized the program, 24.3% male and 75.7% female with a mean (SD) age of 44.03 (7.30) years. The people that have previous experience in mind body practices or cardiovascular diseases were excluded. All the caregivers received information about the study and informed consent was obtained from all participants. This study was approved by the CEI-GR (C-9) ethics committee and followed the principles of the Declaration of Helsinki. Convenience sampling was used to assign caregivers to the control or experimental groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers Burnout

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A meditation master practitioner with at least 10 years of experience implemented in the Faculty of Health Sciences of the University of Granada a FAM program during four weeks, two sessions per week, each Friday. The caregiver attendance to two continues sessions during a total of four hours, two hours per session with thirty minutes of rest between both of them.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation program
Arm Type
Experimental
Arm Description
The experimental group participated in the Meditation program during one month, eight sessions with a total of sixteen hours.
Arm Title
Scientific descriptions about meditation
Arm Type
Active Comparator
Arm Description
The control group received scientific descriptions about meditation.
Intervention Type
Other
Intervention Name(s)
Meditation.
Intervention Description
The caregivers received eight sessions lasting each one two hours with the following sequence: before each practical exercises they always received 15 minutes about scientific theoretical evidence explaining the importance of doing them: to get a comfortable posture they received 25 minutes of mobility, flexibility, balance, strength and endurance exercises. To increase lung capacity, 25 minutes of costal, diaphragmatic and clavicular breathing exercises. Finally, to have an open attitude without distractions or judging they practiced 25 minutes of body awareness exercise observing sensations, thoughts and perceptions with gratitude and compassion.
Intervention Type
Other
Intervention Name(s)
Scientific descriptions about meditation.
Intervention Description
The control group received scientific descriptions about meditation.
Primary Outcome Measure Information:
Title
Change from Baseline in Happiness on the Lima happiness questionnaire after 1 month
Description
Lima happiness questionnaire: Validated self-administered questionnaire consisting of 27 items, integrated into 4 subscales (Positive sense of life, Satisfaction with life, Personal fulfillment and Joy of life), which refer to the level of happiness or satisfaction that the person has with respect to his life. The respondent may be: (1) Strongly agree, (2) Agree, (3) Neither agree nor disagree, (4) Disagree or (5) Strongly disagree, with any question that arises. According to the total score there are 5 levels of happiness: from 27-87: very low happiness, 88-95: low, 96-110: medium, 111-118: high, 119-135: very high.
Time Frame
Baseline and after 1 month
Title
Change from Baseline in Anxiety and Depression on the Hospital Anxiety and Depression Scale (HADS) after 1 month
Description
Validated self-administered instrument for outpatients that advises on the possible presence of anxiety and depression in any non-psychiatric medical consultation. Describe how the patient feels affective and emotionally during the last week. It has 14 items, 7 for each subscale with a scale similar to four points (from 0 to 3). Lower scores reflect better outcomes.
Time Frame
Baseline and after 1 month
Title
Change from Baseline in Heart rate and Heart rate variability after 1 month
Description
We measured short-term HRV using an accepted method in order to assess the cardiovascular balance (Kappussami 2020). We asked participants to lie in a supine position for 10 min of rest with normal breathing (following a metronome at 0.2 Hz) and no external stimulation in a quiet room with a temperature of 22-25 °C.
Time Frame
Baseline and after 1 month
Title
Change from Baseline in Blood pressure/heart rate after 1 month
Description
We measured blood pressure and heart rate before and after the treatment session using an Omron HEM-7320-Z validated automatic oscillometer.
Time Frame
Baseline and after 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People who care for a dependent family member or close relative and live with him/her in the same home for at least two years with a caregiver burden of more than 55 points in Zarit Burden Scale. Exclusion Criteria: People that have previous experience in mind body practices or cardiovascular diseases.
Facility Information:
Facility Name
Lourdes Díaz Rodríguez
City
Granada
ZIP/Postal Code
18016
Country
Spain

12. IPD Sharing Statement

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A MEDITATION PROGRAM IN HIGH-BURDEN INFORMAL CAREGIVERS

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