A MEDITATION PROGRAM IN HIGH-BURDEN INFORMAL CAREGIVERS

NCT ID: NCT04570826

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-03-10

Brief Summary

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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

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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.

Conditions

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Caregivers Burnout

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meditation program

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

Group Type EXPERIMENTAL

Meditation.

Intervention Type OTHER

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.

Scientific descriptions about meditation

The control group received scientific descriptions about meditation.

Group Type ACTIVE_COMPARATOR

Scientific descriptions about meditation.

Intervention Type OTHER

The control group received scientific descriptions about meditation.

Interventions

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Meditation.

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

Scientific descriptions about meditation.

The control group received scientific descriptions about meditation.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consuelo Lourdes Díaz Rodríguez

OTHER

Sponsor Role lead

Responsible Party

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Consuelo Lourdes Díaz Rodríguez

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Lourdes Díaz Rodríguez

Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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Interventional

Identifier Type: -

Identifier Source: org_study_id