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

NCT06713395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-12-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

The control group received standard postoperative care

standard postoperative care

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:

Sponsors & Collaborators

  • The Affiliated Brain Hospital of Nanjing Medical University

    collaborator OTHER_GOV

  • Yang Huang

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2024-02-15
Completion
2024-02-25

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06713395 on ClinicalTrials.gov