A MEDITATION PROGRAM IN HIGH-BURDEN INFORMAL CAREGIVERS

• Sponsor: Consuelo Lourdes Díaz Rodríguez (Other)
• Overall Status: Completed
• CT.gov ID: NCT04570826
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 15.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Caregivers Burnout	Other: Meditation.; Other: Scientific descriptions about meditation.	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.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)
• Primary Purpose: Treatment
• Official Title: EFFECTS OF A MEDITATION PROGRAM ON THE QUALITY OF LIFE IN HIGH-BURDEN INFORMAL CAREGIVERS
• Actual Study Start Date: Dec 10, 2019
• Actual Primary Completion Date: Mar 10, 2020
• Actual Study Completion Date: Mar 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Meditation program The experimental group participated in the Meditation program during one month, eight sessions with a total of sixteen hours.	Other: 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.
Active Comparator: Scientific descriptions about meditation The control group received scientific descriptions about meditation.	Other: Scientific descriptions about meditation.; The control group received scientific descriptions about meditation.

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in Happiness on the Lima happiness questionnaire after 1 month [Baseline and 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.

2. Change from Baseline in Anxiety and Depression on the Hospital Anxiety and Depression Scale (HADS) after 1 month [Baseline and 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.

3. Change from Baseline in Heart rate and Heart rate variability after 1 month [Baseline and 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.

4. Change from Baseline in Blood pressure/heart rate after 1 month [Baseline and 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lourdes Díaz Rodríguez	Granada		Spain	18016

Sponsors and Collaborators

• Consuelo Lourdes Díaz Rodríguez

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Consuelo Lourdes Díaz Rodríguez, Sponsor-Investigator, Universidad de Granada
• ClinicalTrials.gov Identifier: NCT04570826
• Other Study ID Numbers: Interventional
• First Posted: Sep 30, 2020
• Last Update Posted: Sep 30, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Caregiver Burden

Study Results

No Results Posted as of Sep 30, 2020