A Study of the Effect of Short-term Structured Psychologi... | NCT05845294

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

NCT05845294

Sponsor

Zunyi Medical College

Status

Completed

Last Update Posted

May 6, 2023Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

Routine Care
Short-term structured psychological Care

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Apr 13, 2023

First Submission Date that Met QC Criteria

Apr 25, 2023

First Posted Date

May 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

May 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Active Comparator		Procedure: Routine Care
Experimental group	Experimental		Procedure: Short-term structured psychological Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Routine Care	Procedure	Routine care for patients undergoing colorectal cancer stoma	Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1 month
Anxiety of patients was assessed by the Social Impact Scale	Anxiety of patients was assessed by the Social Impact Scale	1 month
Anxiety of patients was assessed by Hospital Anxiety and Depression Scale	Anxiety of patients was assessed by Hospital Anxiety and Depression Scale	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zunyi Medical College		Zunyi	Guizhou	563000	China

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided