PERMA-Based Intervention on Negative Emotions, Adherence, and Complications in Postoperative Glioma Patients (Glioma)

November 27, 2024 updated by: Yang Huang

Analysis of the Effects of PERMA-Based Integrated Psychological Intervention on Negative Emotions, Treatment Adherence, and Complications in Postoperative Glioma Patients

The goal of this clinical trial is to evaluate whether a PERMA-based integrated psychological intervention can reduce negative emotions, enhance treatment adherence, and decrease the risk of complications in postoperative glioma patients.

The main questions it aims to answer are:

Can the PERMA-based psychological intervention significantly improve anxiety and depression scores in postoperative glioma patients? Does the intervention improve treatment adherence, reduce complications, and enhance quality of life compared to standard care? Researchers will compare an observation group receiving the PERMA-based psychological intervention to a control group receiving standard postoperative care to see if the intervention improves patient outcomes.

Participants will:

Receive either standard postoperative care (control group) or PERMA-based psychological intervention for one month (observation group).

Be assessed on:

Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS). Treatment Adherence Scale and Complication Record Form. Quality of Life Scale. Be followed for complications using Kaplan-Meier survival analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The Affiliated Brain Hospital of Nanjing Medical University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ①Meeting the relevant diagnostic criteria from the 5th edition of the World Health Organization Classification of Central Nervous System (CNS) Tumors, and confirmed through postoperative pathological examination;
  • ②Underwent surgical treatment;
  • ③Clear consciousness, with good communication ability, and capable of cooperating with healthcare personnel to complete the study;
  • ④Complete clinical data.

Exclusion Criteria:

  • ①Concurrent diagnosis of other malignant tumors;
  • ②Coexisting cognitive impairment or other psychiatric disorders;
  • ③Combined liver or kidney dysfunction, immune system disorders, or other severe diseases;
  • ④Presence of infectious diseases;
  • ⑤Pregnant or breastfeeding women.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control group
The control group was provided with standard postoperative care
Other: The control group received standard postoperative care
standard postoperative care
Other: observation group
The observation group received an additional PERMA-based integrated psychological intervention
Other: PERMA

  1. Establishment of the Integrated Psychological Intervention Team:

    The team consisted of 2 primary nurses, 4 specialist nurses, 1 psychologist, 2 physicians at the attending level or higher, and 2 researchers.

    Team Responsibilities: The primary and specialist nurses were responsible for implementing the intervention protocol. The physicians handled any adverse reactions experienced by the patients. The researchers were in charge of developing the intervention protocol and collecting data. All team members were required to undergo specialized training from the psychologist and pass an assessment before initiating the intervention.

  2. Protocol Development:

    The intervention protocol, including specific content, team responsibilities, implementation process, and responses to adverse events, was carefully developed in written form by the researchers. The protocol was discussed and approved by all team members before implementation.

  3. Protocol Implementation:

Emotional Support Intervention:

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAS score
Time Frame: After the four-week intervention
Self-rating anxiety scale is a widely used psychological assessment tool designed to evaluate an individual's level of anxiety. There are 20 things on the scale, and a score of 100 is the total, assessing various anxiety-related emotions experienced by the participant over the past week. Each item is rated on a 4-point Likert scale, ranging from "no anxiety" to "extremely severe anxiety," where higher scores indicate more severe anxiety. Prior to and one month following the intervention, the SAS scores for each group were documented.
After the four-week intervention
SDS score
Time Frame: After the four-week intervention
Self-rating depression scale is a commonly used psychological assessment tool designed to evaluate an individual's level of depression. The scale typically consists of 20 items, with a total score of 100, covering various aspects of depression. Using a 4-point Likert scale that goes from "no depression" to "extremely severe depression," participants describe their moods over the course of the previous week. Higher scores signify more severe depression. The SDS scores for both groups were recorded before and one month after the intervention.
After the four-week intervention
treatment adherence
Time Frame: After the four-week intervention
Complete adherence: The patient actively cooperated with the medical and nursing staff, followed all prescribed treatments and interventions, and complied with medication, examinations, and other medical recommendations on a daily basis. Partial adherence: The patient generally cooperated with the medical and nursing staff but may not have fully adhered to all instructions. Non-adherence: The patient showed poor cooperation, requiring multiple reminders and explanations to comply with treatment protocols. The adherence rate was calculated as the sum of the complete and partial adherence rates. Adherence was recorded one month after the intervention.
After the four-week intervention
Incidence of postoperative complications
Time Frame: During the four-week intervention
During the four-week intervention
The World Health Organization Quality of Life Brief Scale scores
Time Frame: After the four-week intervention
WHOQOL-BREF is a tool used to assess an individual's quality of life. This scale consists of 26 items, each with five options, rated from 1 to 5, with higher scores reflecting better outcomes (or from very satisfied to extremely dissatisfied). However, items 3, 4, and 26 are reverse-scored. Additionally, there are separate scores for family friction, appetite, and self-assessed survival quality. The scale covers four domains: physical health, psychological health, social relationships, and environment. Participants rate their experiences over the past two weeks. Each domain score is calculated by summing the relevant item scores and standardizing them, yielding a range from 0 to 100, with higher scores indicating better quality of life.
After the four-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
general characteristics
Time Frame: At the time of patient enrollment
Index: Gender, Age (years), BMI/ (kg/m2), Degree of education, History of diabetes, History of high blood pressure.
At the time of patient enrollment

Collaborators and Investigators

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

Sponsor

Yang Huang

Collaborators

The Affiliated Brain Hospital of Nanjing Medical University

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)

January 10, 2022

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 25, 2024

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-KY091-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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