Psychological Predictors in Colorectal IBD Surgery Recovery

NCT ID: NCT03893942

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2021-04-30

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Questionnaires administration

Psychological and quality of life questionnaires

Intervention Type: 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.

Intervention Type: 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

Intervention Type: OTHER

Cognitive Flexibility Scale (CFS)

The CFS is 12-item self-report test assessing awareness.

Intervention Type: OTHER

Life Orientation Test (LOT)

The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.

Intervention Type: OTHER

Mini Locus of Control test (MLS)

The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonino Spinelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery

Rozzano, MI, Italy

Countries

Italy

Other Identifiers

2214

Identifier Type: -

Identifier Source: org_study_id