PERMA-Based Intervention on Negative Emotions, Adherence, and Complications in Postoperative Glioma Patients
NCT ID: NCT06713395
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2022-01-10
2024-02-25
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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control group
The control group was provided with standard postoperative care
The control group received standard postoperative care
standard postoperative care
observation group
The observation group received an additional PERMA-based integrated psychological intervention
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:
Interventions
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The control group received standard postoperative care
standard postoperative care
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:
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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The Affiliated Brain Hospital of Nanjing Medical University
OTHER_GOV
Yang Huang
OTHER_GOV
Responsible Party
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Yang Huang
The Affiliated Brain Hospital of Nanjing Medical University
Locations
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The Affiliated Brain Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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2020-KY091-01
Identifier Type: -
Identifier Source: org_study_id