CompletedNot Applicable

Roy Adaptation Model Improves Mood and QOL After Giant Acoustic Neuroma

China160 participantsStarted 2022-01-01

Plain-language 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. 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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Self-Rating Anxiety Scale (SAS)

Timeframe: 1 year

Self-Rating Depression Scale (SDS)

Timeframe: 1 year

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

Timeframe: 1 year

Trial details

NCT IDNCT07305285

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-12

View on ClinicalTrials.gov More Acoustic Neuroma trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.