The Effects of Mindfulness-Based Stress Reduction Program for Family or Caregivers of Children With Motor Disabilities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-Based Stress reduction.
- Who it may be relevant to
- Registry conditions: Stress, Psychological, Stress, Emotional, Stress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effects of Mindfulness-Based Stress Reduction Program on the Psychological and Physiological Stress of Family or Caregivers of Children With Motor Disabilities Due to a Neurological Disorder: A Randomized Controlled Trial
Overview
The present study aims to investigate the effect of a mindfulness-based program on perceived stress, severity of anxiety, parents'/caregivers' quality of life and their children, cortisol and IL-6 blood concentrations.
Interventions
- Behavioral Mindfulness-Based Stress reduction
Participants assigned to the 8-week mindfulness program attended weekly 120-150 minute in-person group sessions for the entire duration. In these sessions, the instructor progressively will introduce and guide formal mindfulness practices while facilitating the sharing of experiences.
Primary outcome measures
- Perceived Stress [Time frame: baseline, two months (through study completion), and follow-up of one month]
- Cortisol levels [Time frame: baseline and two months (through study completion)]
Secondary outcome measures (7)
- Severity of clinic anxiety [Time frame: baseline, two months (through study completion), and follow-up of one month]
- Sleep Quality [Time frame: baseline, two months (through study completion), and follow-up of one month]
- Quality of Life assessment [Time frame: baseline, two months (through study completion), and follow-up of one month]
- Blood pressure [Time frame: baseline, two months (through study completion), and follow-up of one month]
- Resting Heart rate [Time frame: baseline, two months (through study completion), and follow-up of one month]
- Respiratory rate [Time frame: baseline, two months (through study completion), and follow-up of one month]
- Interleukin 6 (IL-6) [Time frame: baseline and two months (through study completion)]
Eligibility criteria
Inclusion criteria
- Not having attended previously a mindfulness course
- A score equal to or greater than 23 points at the PSS.
- >18 years old
- Children <18y with motor/physical disability due to a Neurological disorder.
- Spanish/Catalan speaking
Exclusion criteria
- Currently using drugs or any kind of medication related to stress, depression, anxiety or sleeping pills, such as steroid medicines.
- Regular meditation practice (once a week in the past 12 months)
- Diagnose of hypertension stage 2
- Pregnancy in the case of mothers
- Present hyperthyroidism
- Primary adrenal insufficiency syndromes such as Cushing syndrome or Addison disease
- Present any kind of infection or inflammation process, different from the interestingly to the present study that could differ the results
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Claudia Arumi — Lleida
Identifiers
NCT: NCT06557486 · ULleida2