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Clinical Trials/NCT02991443
NCT02991443CompletedNot Applicable

The Effect of Mindfulness Based Stress Reduction on Parents of Children With Inflammatory Bowel Disease

Schneider Children's Medical Center, Israel2 sites in 1 country30 target enrollmentStarted: December 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
The change in perceived stress scale

Study Overview

Brief Summary

Parents of children with chronic diseases often report increased level of stress and anxiety. The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR) intervention on stress and anxiety of parents of children with inflammatory bowel diseases (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist. 30 parents will participate. The efficacy of the intervention will be assessed by 3 validated questionnaires which will be filled by each participant prior to intervention, at the end of intervention and 3 months following interventions.

Detailed Description

Parents of children with chronic diseases often report increased level of stress and anxiety. Inflammatory bowel diseases (IBD), including crohn's disease and ulcerative colitis are chronic debilitating conditions with significant implications of both patients and parents. Thus, there is a necessity to address the stress and anxiety derived from parenting a child with IBD.

Mindfulness is the psychological process of bringing one's attention to the internal and external experiences occurring in the present moment,which can be developed through the practice of meditation and other training. Clinical studies have documented both physical and mental health benefits of mindfulness in different patient categories as well as in healthy adults and children.

The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR) intervention on stress and anxiety of parents of children with inflammatory bowel diseases (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist. 30 parents will participate in 4 separated courses. The efficacy of the intervention will be assessed by 3 validated questionnaires which will be filled by each participant prior to intervention, at the end of intervention and 3 months following interventions: Profile of mood states (POMS), The brief symptom inventory (BSI) and perceived stress scale (PSS). Differences in questionnaires' scores will be analyzed.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A parent to an IBD patient who is younger than 18 years of age

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The change in perceived stress scale

Time Frame: At baseline and 3 months following intervention

Secondary Outcomes

  • The change in profile of mood states (POMS) score(At week 0 following intervention and 3 months following intervention compared with baseline)
  • The change in brief symptom inventory (BSI) score(At week 0 following intervention and 3 months following intervention compared with baseline)

Investigators

Sponsor
Schneider Children's Medical Center, Israel
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amit Assa

Head of IBD program

Schneider Children's Medical Center, Israel

Study Sites (2)

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