Clinical Trials Directory

Trials / Completed

CompletedNCT07305285

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
160 (actual)
Sponsor
West China Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALRAM-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.

Timeline

Start date
2022-01-01
Primary completion
2024-12-12
Completion
2024-12-30
First posted
2025-12-26
Last updated
2025-12-26

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07305285. Inclusion in this directory is not an endorsement.