A MEDITATION PROGRAM IN HIGH-BURDEN INFORMAL CAREGIVERS

NCT04570826 | Completed DMC

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregivers Burnout

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and after 1 month

• 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.

  Baseline and after 1 month

• 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.

  Baseline and after 1 month

• 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.

  Baseline and after 1 month

Study Arms (2)

Meditation program

EXPERIMENTAL

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

Other: Meditation.

Scientific descriptions about meditation

ACTIVE COMPARATOR

The control group received scientific descriptions about meditation.

Other: Scientific descriptions about meditation.

Interventions

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.

Meditation program

Scientific descriptions about meditation. OTHER

The control group received scientific descriptions about meditation.

Scientific descriptions about meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Consuelo Lourdes Díaz Rodríguez: lead

Study Sites (1)

Lourdes Díaz Rodríguez

Granada, 18016, Spain

Location

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 30, 2020
• Study Start: December 10, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

ES (1)