Acoustic NeuromaNCT07305285
Roy Adaptation Model Improves Mood and QOL After Giant Acoustic Neuroma
A study testing RAM-Based Nursing + RAM Follow-Up Care in people with Acoustic Neuroma and Facial Paralysis, run by West China Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acoustic Neuroma, Facial Paralysis
- What is being tested?
- RAM-Based Nursing + RAM Follow-Up Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Conditions
- Acoustic Neuroma, Facial Paralysis
- Being tested
- RAM-Based Nursing + RAM Follow-Up Care
- Keywords
- Roy Adaptation Model, Psychological state, Quality of life, Stress cytokines
- Medical subject headings
- Neuroma, Acoustic, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAM-Based Nursing + RAM Follow-Up CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: RAM-Based Nursing + RAM Follow-Up Care |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
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:
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Jan 2022
- Primary completion12 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acoustic NeuromaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305285
- Sponsor's protocol ID
- WestChinaH-HX-2025-02
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and Informed consent
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07305285
- Acronym / sponsor ID
- WestChinaH-HX-2025-02
- Conditions
- Acoustic Neuroma, Facial Paralysis
- Keywords
- Roy Adaptation Model, Psychological state, Quality of life, Stress cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: RAM-Based Nursing + RAM Follow-Up CareRAM-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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAM-Based Nursing + RAM Follow-Up CareCore 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. | Behavioural | Intervention Group |
Primary outcome
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
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
World Health Organization Quality of Life-Brief(WHOQOL-BREF)
Time frame: 1 year
1. 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. 2. 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). 3. 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 secondary outcome
Facial Nerve Electrophysiological Indicators
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Yes. Protocol and Informed consent
Related trials for Acoustic Neuroma
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Not yet recruitingPhase 2
Selumetinib for NF2-Related Schwannomatosis
Neurofibromatosis Type 2, NF2
RecruitingPhase 2
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
Neurofibromatosis Type 2, Vestibular Schwannoma
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAM-Based Nursing + RAM Follow-Up Care in people with Acoustic Neuroma and Facial Paralysis, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Rating Anxiety Scale (SAS) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.