Back to resultsA Study of the Effect of Short-term Structured Psychological Care in Patients
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Routine Care
Short-term structured psychological Care
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: voluntary participation in the study and ability to cooperate with treatment and care; patients who were to undergo enterostomy; age ≥18 years; consciousness (being able to complete the questionnaire alone or able to answer the questions correctly); social impact scale (SIS) score ≥24. Exclusion Criteria: Critically ill and unable to cooperate with the study; Impaired cognitive function that affects communication; Patients with other organic diseases in combination.
Sites / Locations
- Zunyi Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
Outcomes
Primary Outcome Measures
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
Anxiety of patients was assessed by the Social Impact Scale
Anxiety of patients was assessed by the Social Impact Scale
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05845294
Brief Title
A Study of the Effect of Short-term Structured Psychological Care in Patients
Official Title
A Study of the Effect of Short-term Structured Psychological Care on the Level of Postoperative Stigma in Patients With Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zunyi Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Experimental group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Routine Care
Intervention Description
Routine care for patients undergoing colorectal cancer stoma
Intervention Type
Procedure
Intervention Name(s)
Short-term structured psychological Care
Intervention Description
Short-term structured psychological care for colorectal cancer stoma patients based on conventional care
Primary Outcome Measure Information:
Title
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
Description
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
Time Frame
1 month
Title
Anxiety of patients was assessed by the Social Impact Scale
Description
Anxiety of patients was assessed by the Social Impact Scale
Time Frame
1 month
Title
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
Description
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
voluntary participation in the study and ability to cooperate with treatment and care;
patients who were to undergo enterostomy;
age ≥18 years;
consciousness (being able to complete the questionnaire alone or able to answer the questions correctly);
social impact scale (SIS) score ≥24.
Exclusion Criteria:
Critically ill and unable to cooperate with the study;
Impaired cognitive function that affects communication;
Patients with other organic diseases in combination.
Facility Information:
Facility Name
Zunyi Medical College
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563000
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effect of Short-term Structured Psychological Care in Patients
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