Clinical trial NCT06713395: PERMA-Based Intervention on Negative Emotions, Adherence, and Complications in Postoperative Glioma Patients
Official title: Analysis of the Effects of PERMA-Based Integrated Psychological Intervention on Negative Emotions, Treatment Adherence, and Complications in Postoperative Glioma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioma
Keywords: PERMA
Glioma
Integrated psychological intervention
SAS
SDS
complication
Lead sponsor: The Affiliated Brain Hospital of Nanjing Medical University
Sponsor class: OTHER_GOV
Collaborators: name: The Affiliated Brain Hospital of Nanjing Medical University
First posted: 2024-12-03
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: SAS score
timeFrame: After the four-week intervention
measure: SDS score
timeFrame: After the four-week intervention
measure: treatment adherence
timeFrame: After the four-week intervention
measure: Incidence of postoperative complications
timeFrame: During the four-week intervention
measure: The World Health Organization Quality of Life Brief Scale scores
timeFrame: After the four-week intervention
Secondary outcomes:
measure: general characteristics
timeFrame: At the time of patient enrollment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Brain Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: