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Completed

NCT Number: NCT04570826

A MEDITATION PROGRAM IN HIGH-BURDEN INFORMAL CAREGIVERS

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.

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Key information

Conditions

Caregivers Burnout

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lourdes Díaz Rodríguez

Granada, 18016, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Meditation.

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.

Other

The control group received scientific descriptions about meditation.

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Consuelo Lourdes Díaz Rodríguez

Other

Registry information

Official study title

EFFECTS OF A MEDITATION PROGRAM ON THE QUALITY OF LIFE IN HIGH-BURDEN INFORMAL CAREGIVERS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2020
Registry last updated
Sep 30, 2020

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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