The Effects of Mindfulness-Based Stress Reduction Program for Family or Caregivers of Children With Motor Disabilities
NCT Number: NCT06557486
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress, Psychological|Stress, Emotional|Stress
Interventions: BEHAVIORAL: Mindfulness-Based Stress reduction
Sponsor: Universitat de Lleida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2025-06
Locations: Claudia Arumi, Lleida, 25006, Spain

Summary:
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.

Primary Outcome Measures: 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: 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)