The Effects of Mindfulness-Based Stress Reduction Program for Family or Caregivers of Children With Motor Disabilities

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Stress, Psychological; Stress, Emotional
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress reduction

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25006
    • Claudia Arumi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Mindfulness-Based Stress reduction arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress	To measure participants perceived stress, the Perceived Stress Scale 14 item Spanish version will be used (PSS 14). It consists of 14 items scored from 0 up to 4 (0=never, 1 = rarely 2= sometimes 3= usually 4 =almost always). The total scores on the scale can range from 0 (no stress) to 56 (extreme stress).	baseline, two months (through study completion), and follow-up of one month
Cortisol levels	The cortisol measurement will be sampled with a serum blood test. It is recommended to advise the participants to be fasted. 63 Cortisol levels fluctuate throughout the day, being highest in the morning and lowest at night.63,64 The sample will be collected between 8-9 am to get the highest cortisol.	baseline and two months (through study completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of clinic anxiety	To measure the severity of clinic anxiety, the Bech Anxiety Inventory will be used. It consists of 21 self-administered questions about how the individual has been feeling the last week, expressed in common anxiety symptoms. It takes up to 5-10 minutes. Scores 0-7 indicate minimal anxiety, 8-15 mild anxiety, 16-25 moderate anxiety and 26-63 severe anxiety. Each item on the BAI includes an anxiety symptom and for each of them, the participant must assess the degree to which they have been affected by it during the last week. Possible answers are: not at all, mildly but it didn't bother me much, moderately it wasn't pleasant at times, severely it bothered me a lot. (0 to 3 respectively).	baseline, two months (through study completion), and follow-up of one month
Sleep Quality	To measure sleep quality, the Pittsburgh Sleep Quality Index (PSQI) will be assessed. It is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The instrument should require between 5 and 10 min for completion. The questionnaire consists of a combination of Likert-type and open-ended questions (later converted to scaled scores using provided guidelines). Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances. Developers have suggested a cutoff score of 5 for the global scale. The seven component scores are then combined to produce a global PSQI score, which ranges from 0 to 21; higher scores reflect poorer sleep quality	baseline, two months (through study completion), and follow-up of one month
Quality of Life assessment	To measure the impact of paediatric chronic health conditions on parents and the family, the last developed PedsQL™ Family Impact Module will be used. The module measures multidimensions parent self-report; physical, emotional, social, and cognitive functioning, communication, and worry. It is used to assess health-related QoL in children aged 2-18 years. It takes up to 5-10 minutes to be completed.It assesses 8 main factors: physical functioning (6 items), emotional functioning (5 items), social functioning (4 items), cognitive functioning (4 items), communication (3 items), worry (5 items), daily activities (3 items) and family relationships (5 items). The answers are given on a 5-point Likert scale (0 = it is never a problem, 4 = it is almost always a problem) and are reversed scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) so that a greater score indicates better functioning	baseline, two months (through study completion), and follow-up of one month
Blood pressure	BP will be measured, after 5 min of rest, three times at intervals of 1 minute using a sphygmomanometer. The clinical BP values used in the analysis will be the averages for the three measurements. BP measurements will be done pre-intervention, post-intervention and with a follow-up of one mont. both systolic and diastolic measures.	baseline, two months (through study completion), and follow-up of one month
Resting Heart rate	HR will be measured, after 5 min of rest, three times at intervals of 1 minute using a pulsometer on the index finger. The clinical HR values used in the analysis will be the averages for the three measurements.	baseline, two months (through study completion), and follow-up of one month
Respiratory rate	Respiratory rate will be measured after 5 min of rest, three times at intervals of 1 minute using the same sphygmomanometer of the BP. The clinical RR values used in the analysis will be the averages for the three measurements. RR measurements will be done pre-intervention, post-intervention and with a follow-up of one month.	baseline, two months (through study completion), and follow-up of one month
Interleukin 6 (IL-6)	The same procedure will be taken for the IL-6 .65 Under homeostatic conditions, IL-6 levels in the circulation are as low as 1-5 pg/ml, but during inflammatory states, these levels can rise more than 1,000-fold	baseline and two months (through study completion)

Collaborators and Investigators

• Sponsor: Universitat de Lleida

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: ULleida2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No