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Roy Adaptation Model Improves Mood and QOL After Giant Acoustic Neuroma

NCT ID: NCT07305285

Last Updated: 2025-12-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-30

Brief Summary

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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

Detailed Description

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Conditions

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Acoustic Neuroma Facial Paralysis

Keywords

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Roy Adaptation Model Psychological state Quality of life Stress cytokines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

RAM-Based Nursing + RAM Follow-Up Care

Intervention Type BEHAVIORAL

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhigang Lan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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WestChinaH-HX-2025-02

Identifier Type: -

Identifier Source: org_study_id