NCT03893942

Psychological Predictors in Colorectal IBD Surgery Recovery

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-16
• Primary completion: 2020-10-25
• Completion: 2021-04-01
• First posted: 2019-03-28
• Last updated: 2021-02-03

Locations

1 site across 1 country: Italy