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NCT Number: NCT07305285

Roy Adaptation Model Improves Mood and QOL After 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

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Key information

Conditions

Acoustic Neuroma Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Facial Paralysis Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Paralysis Pathological Conditions, Signs and Symptoms Peripheral Nervous System Neoplasms Retrocochlear Diseases Signs and Symptoms Stomatognathic Diseases Vestibulocochlear Nerve Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RAM-Based Nursing + RAM Follow-Up Care

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.

Primary outcomes

  1. Self-Rating Anxiety Scale (SAS)

    Time frame: 1 year

    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

  2. Self-Rating Depression Scale (SDS)

    Time frame: 1 year

    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

  3. World Health Organization Quality of Life-Brief(WHOQOL-BREF)

    Time frame: 1 year

    • 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.

Secondary outcomes

  1. Facial Nerve Electrophysiological Indicators

    Time frame: 1 year

    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:

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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