Clinical trial NCT04570826: 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
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers Burnout
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Happiness on the Lima happiness questionnaire after 1 month
timeFrame: Baseline and after 1 month
measure: Change from Baseline in Anxiety and Depression on the Hospital Anxiety and Depression Scale (HADS) after 1 month
timeFrame: Baseline and after 1 month
measure: Change from Baseline in Heart rate and Heart rate variability after 1 month
timeFrame: Baseline and after 1 month
measure: Change from Baseline in Blood pressure/heart rate after 1 month
timeFrame: Baseline and after 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Lourdes Díaz Rodríguez
Study officials:
References: