Roy Adaptation Model Improves Mood and QOL After Giant Acoustic Neuroma

An Investigation Into the Effects and Mechanisms of Nursing Based on the Roy Adaptation Model on Psychological Status and Quality of Life in Patients Experiencing Facial Paralysis After Surgery for Giant Acoustic Neuroma

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

Study Overview

• Status: Completed
• Conditions: Acoustic Neuroma; Facial Paralysis
• Intervention / Treatment: Behavioral: RAM-Based Nursing + RAM Follow-Up Care

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Rating Anxiety Scale (SAS)	all are 20 items. The total score ranges from 20 to 80. A cut-off score of 50 indicates significant anxiety (scores ≥50 suggest anxiety symptoms). the higher the score, the worse the outcome	1 year
Self-Rating Depression Scale (SDS)	all are 20 items. The total score ranges from 20 to 80. A cut-off score of 53 indicates significant depression (scores ≥53 suggest depressive symptoms). the higher the score, the worse the outcome	1 year
World Health Organization Quality of Life-Brief(WHOQOL-BREF)	Reverse Scoring: For item 6 (pain/discomfort), reverse the score (1=5, 2=4, 3=3, 4=2, 5=1) because higher scores on this item indicate poorer quality of life. All other items are scored as per the original response.; Domain Scores: Calculate the average score for each domain (Physical Health: Items 1-8; Psychological Health: Items 9-14; Social Relationships: Items 15-17; Environmental Domain: Items 18-26).; Standardization: Convert each domain average score to a standard score (0-100) using the formula: Standard Score = [(Average Score - 1) / 4] × 100. Higher standard scores indicate better quality of life in that domain.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial Nerve Electrophysiological Indicators	Assessed at baseline, 8 weeks, 6 months, and 1 year using a neuroelectromyography (EMG) instrument (Nicolet VikingSelect, USA) by a specialized neurologist blinded to group allocation:	1 year

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 12, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Roy Adaptation Model; Psychological state; Stress cytokines
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Neuroendocrine Tumors; Ear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Paralysis; Neuroma; Cranial Nerve Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neurilemmoma; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuroma, Acoustic; Facial Paralysis
• Other Study ID Numbers: WestChinaH-HX-2025-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol and Informed consent

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No