An interventional study of RAM-Based Nursing + RAM Follow-Up Care in Acoustic Neuroma and Facial Paralysis, sponsored by West China Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by West China Hospital · Not applicable, Interventional, and Supportive care
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
100 studies on the registry are indexed under Neuroma, Acoustic; 28 are open to participants now.
This study's enrollment of 160 is above the median of 27 across 65 interventional studies indexed under Neuroma, Acoustic.
Browse Neuroma, Acoustic studies →West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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
Time frame: 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
Time frame: 1 year
World Health Organization Quality of Life-Brief(WHOQOL-BREF)
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.
Time frame: 1 year
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:
Time frame: 1 year
Plan to share: Yes — Protocol and Informed consent
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Dec 2024, 35 months.
Of 24 interventional studies with no phase under Neuroma, Acoustic, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 146. This study's 35 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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