Roy Adaptation Model Improves Mood and QOL After Giant Acoustic Neuroma

Sichuan University

Status: Completed

Conditions: Acoustic Neuroma; Facial Paralysis

Treatments: Behavioral: RAM-Based Nursing + RAM Follow-Up Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07305285

WestChinaH-HX-2025-02

Details and patient eligibility

About

he goal of this randomized controlled trial is to learn if the Roy Adaptation Model (RAM) nursing program improves anxiety, depression, and quality of life in adults who have recently developed facial palsy. It will also learn about changes in stress-related blood markers. The main questions it aims to answer are: Does 12-week RAM nursing lower anxiety and depression scores compared with routine nursing? Does RAM nursing raise quality-of-life scores and beneficially alter serum levels of cortisol, IL-6, TNF-α, serotonin, and dopamine? Researchers will compare RAM nursing (one-to-one education, cognitive-behavioral support, facial-movement training, family counseling, and phone follow-up) to routine facial-palsy education only.

Participants will:

Receive either RAM nursing or routine nursing for 12 weeks Complete anxiety, depression, and quality-of-life questionnaires at baseline and week 12 Provide blood samples at baseline and week 12 to measure stress and inflammation markers

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed GAN by preoperative MRI (tumor diameter >4 cm) and postoperative pathological examination;
• Postoperative facial paralysis diagnosed by neurological examination, with House-Brackmann (HB) grade ≥Ⅱ;
• Age 18-65 years;
• Conscious, with normal cognitive function (Mini-Mental State Examination score ≥24), able to communicate and complete questionnaires independently;
• No history of psychological disorders or antidepressant/anxiolytic use before surgery;
• Signed informed consent.

Exclusion criteria

• Preoperative facial paralysis, facial nerve palsy, or other facial muscle diseases;
• History of schizophrenia, bipolar disorder, or other mental illnesses;
• Severe postoperative complications (e.g., intracranial infection, hemorrhage, cerebrospinal fluid leakage) requiring reoperation;
• Pregnancy or lactation;
• Severe liver, kidney, or cardiovascular diseases;
• Loss to follow-up or refusal to participate in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Intervention Group

Experimental group

Description:

RAM-Based Nursing + RAM Follow-Up Care：Core intervention (8 weeks): As described in the original protocol (four adaptation modes: physiological, self-concept, role function, interdependence). * Long-term follow-up (week 9 to 1 year): * Monthly online consultations (20-30 min/time): Via WeChat or video call to assess adaptation status (physical symptoms, psychological state, social participation); adjust self-management plans (e.g., facial muscle training intensity, psychological coping strategies). * Quarterly face-to-face visits (40-60 min/time): Conduct comprehensive assessment of facial nerve function (HB grade re-evaluation), psychological state, QoL, and electrophysiological function; organize peer support group meetings (semi-annually) to share long-term recovery experiences; strengthen family support guidance.

Treatment:

Behavioral: RAM-Based Nursing + RAM Follow-Up Care

Control group

No Intervention group

Description:

Routine Nursing + Routine Follow-Up * Core intervention (8 weeks): As described in the original protocol (postoperative basic care, standardized facial muscle training, health education, brief psychological support). * Long-term follow-up (week 9 to 1 year): Quarterly telephone follow-up (10-15 min/time) to inquire about facial function, psychological status, and adherence to training; provide verbal health education and guidance when necessary.