Inflammatory Bowel Diseases
Conditions
Keywords
Inflammatory Bowel Diseases, Mindfulness, Psychological predictors, Colorectal surgery
Brief summary
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
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.
Interventions
Psychological and quality of life questionnaires
The LMS is a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.
OTHERMindful 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
The CFS is 12-item self-report test assessing awareness.
The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.
The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.
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
The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between psychological predictors questionnaires outcome and length of hospital stay | Post-operative day 7 | Length of stay calculated in days from the day of surgery until the day of discharge |
| Correlation between psychological predictors questionnaires outcome and quality of life | Post-operative day 30 | Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S\_IBDQOL) |
Countries
Italy
Outcome results
None listed