A Study of the Effect of Short-term Structured Psychological Care in Patients

April 25, 2023 updated by: Xu Ren, Zunyi Medical College

A Study of the Effect of Short-term Structured Psychological Care on the Level of Postoperative Stigma in Patients With Colorectal Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Zunyi Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. voluntary participation in the study and ability to cooperate with treatment and care;
  2. patients who were to undergo enterostomy;
  3. age ≥18 years;
  4. consciousness (being able to complete the questionnaire alone or able to answer the questions correctly);
  5. social impact scale (SIS) score ≥24.

Exclusion Criteria:

  1. Critically ill and unable to cooperate with the study;
  2. Impaired cognitive function that affects communication;
  3. Patients with other organic diseases in combination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Procedure: Routine Care
Routine care for patients undergoing colorectal cancer stoma
Experimental: Experimental group
Procedure: Short-term structured psychological Care
Short-term structured psychological care for colorectal cancer stoma patients based on conventional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
Time Frame: 1 month
Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale
1 month
Anxiety of patients was assessed by the Social Impact Scale
Time Frame: 1 month
Anxiety of patients was assessed by the Social Impact Scale
1 month
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
Time Frame: 1 month
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zunyi Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zunyi002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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