Psychological Predictors in Colorectal IBD Surgery Recovery

Study Overview
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Brief Summary
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This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal surgery for Inflammatory Bowel Diseases (IBD), including Crohn's disease and Ulcerative Colitis.

Detailed Description
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The chronic nature of Inflammatory Bowel Disease (IBD) leads to a significant impact on patients' lives, beyond intestinal symptoms alone. The sequelae of this can be seen in the increased rates of depression and reduced quality of life (QoL). Surgery may provide a way to effectively induce long-term symptoms remission, although there is a short postoperative transitory period whereas quality of life might decrease. Over the last years, increasing interest has been gained by perioperative recovery protocols, aiming to accelerate functional recovery and to reduce complications. Some of these protocols include an in-depth discussion with both dedicated nurses and/or surgeons to decrease surgery-associated stress reaction. Nevertheless, no one of the proposed protocols has included a psychological assessment in order to correlate it with functional recovery. We suggest that studying the psychological characteristics of the patients (with a specific focus on mindfulness) could lead to open a new research front to optimize patients' outcomes.

Official Title
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Psychological Predictors of Post-surgical Recovery in Inflammatory Bowel Disease: a Pilot Cohort Study

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: Questionnaires administration
* Other: Langer Mindfulness Scale (LMS)
* Other: Mindful Attention Awareness Scale (MAAS)
* Other: Cognitive Flexibility Scale (CFS)
* Other: Life Orientation Test (LOT)
* Other: Mini Locus of Control test (MLS)
* Other: Hospital Anxiety and Depression Scale (HADS)
* Other: Perceived Stress Scale (PSS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years old (both males and females). Patients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis). Patients scheduled for elective open or laparoscopic surgery for curative intent. Exclusion Criteria: Patients unable to give the written informed consent. Patients < 18 years old. Patients undergoing surgery in emergency setting. Patients with pre-operative evidence of colorectal cancer or High Grade/Low grade dysplasia. Pregnant or breastfeeding patients. Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaires administration|Psychological and quality of life questionnaires|
|Other: Langer Mindfulness Scale (LMS)|The LMS is a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.|
|Other: Mindful Attention Awareness Scale (MAAS)|The MAAS is a 15-item questionnaire, designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present|
|Other: Cognitive Flexibility Scale (CFS)|The CFS is 12-item self-report test assessing awareness.|
|Other: Life Orientation Test (LOT)|The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.|
|Other: Mini Locus of Control test (MLS)|The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.|
|Other: Hospital Anxiety and Depression Scale (HADS)|The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology|
|Other: Perceived Stress Scale (PSS)|The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between psychological predictors questionnaires outcome and length of hospital stay | Length of stay calculated in days from the day of surgery until the day of discharge | Post-operative day 7 | 
| Correlation between psychological predictors questionnaires outcome and quality of life | Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL) | Post-operative day 30 | 
| Correlation between psychological predictors questionnaires outcome and quality of life | Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL) | Post-operative day 90 | 
| Correlation between psychological predictors questionnaires outcome and quality of life | Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL) | Post-operative month 6 | 
| Correlation between psychological predictors questionnaires outcome and quality of life | Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL) | Post-operative month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Diseases, Mindfulness, Psychological predictors, Colorectal surgery