- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302672
Humanistic Continuing Care Via WeChat for Patients Undergoing Thermal Ablation of Papillary Thyroid Carcinoma
The goal of this clinical trial is to test whether human-centered nursing care lowers emotional distress and improves quality of life for people who are awake during thyroid thermal ablation. The procedure uses local anesthesia, so participants remain awake and may feel tense. Human-centered care focuses on emotional support, clear communication, comfort, and follow-up, and it may improve the experience and recovery for patients.
The main questions are:
Does human-centered nursing care reduce emotional distress levels in patients undergoing thyroid thermal ablation?
Does human-centered nursing care improve patient quality of life after thyroid thermal ablation?
If there is a comparison group: Researchers will compare human-centered nursing care to usual nursing care to see if human-centered care leads to lower emotional distress and higher quality of life.
Participants will:
Receive either human-centered nursing care or usual nursing care.
Complete questionnaires before, during, and after the procedure to measure emotional distress, quality of life, pain, and satisfaction with care.
Have their vital signs and quality of life tracked during and after the procedure.
Have their adherence to care plans and any complications monitored.
The main outcomes are emotional distress levels and quality of life. Other outcomes include pain and vital signs during the procedure, satisfaction with care, and complication rates. Results may guide better care for people undergoing small, minimally invasive treatments while awake.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ming-an yu, MD
- Phone Number: 84205756
- Email: yma301@163.com
Study Locations
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-
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Beijing, China
- Recruiting
- China-Japan Friendship Hospital
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Contact:
- ming-an yu
- Phone Number: 84205756
- Email: yma301@163.com
-
Contact:
- yan li
- Phone Number: 84205756
- Email: 497059493@qq.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 16-60 years; scheduled for thyroid thermal ablation
- Papillary thyroid carcinoma (PTC)
- Number of target lesions <= 3
- Largest lesion diameter <= 2 cm; clinical stage T1N0M0 by imaging
- Awake and able to cooperate under local anesthesia
Owns a smartphone and can use WeChat
Exclusion Criteria:
- Serious medical comorbidities or cognitive impairment that precludes participation
- Prior thyroid surgery or thermal ablation
- Unwilling or unable to join the WeChat group or complete postoperative follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Humanistic Continuing Care via WeChat
|
Description: Structured, humanistic peri-operative nursing program delivered through WeChat in addition to routine care. Components: pre-procedure needs assessment and expectation setting; brief coping skills coaching (e.g., paced breathing); intra-procedure step-by-step explanations, reassurance, and comfort measures; post-procedure education, recovery guidance, and psychosocial support; symptom monitoring with red-flag escalation; medication/wound-care and appointment reminders; on-demand messaging during service hours; optional caregiver engagement. Delivery & Schedule: Nurse-led. One pre-procedure session; intra-procedure support on the day of ablation; post-procedure WeChat check-ins at least weekly plus on-demand messaging for 12 weeks. Fidelity tracked via standardized checklists. Arm(s): Experimental - Humanistic Continuing Care via WeChat. |
|
Active Comparator: Usual Care (No Structured WeChat Program)
|
Participants receive standard peri-operative nursing and institutional discharge materials, including routine pre-procedure counseling, standard intra-procedure monitoring, printed/posted instructions for home care, and follow-up per usual practice (e.g., clinic visit or routine phone call).
They may contact the clinic using standard channels as needed, but there is no scheduled, structured WeChat outreach or humanistic continuing-care protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in emotion distress from baseline to post-procedure (HADS)
Time Frame: From enrollment to the end of treatment at 3 months
|
From enrollment to the end of treatment at 3 months
|
|
Change in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 scores from baseline to 3 months
Time Frame: From enrollment to the end of treatment at 3 months
|
From enrollment to the end of treatment at 3 months
|
|
Change in Thyroid Cancer-Specific Quality of Life Questionnaire scores from baseline to 3 months
Time Frame: From enrollment to 3 months after end of treatment
|
From enrollment to 3 months after end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative pain intensity (Visual Analog Scale)
Time Frame: Intraoperative period (during the procedure)
|
Pain intensity during the procedure will be assessed using a Visual Analog Scale (VAS; 0-100 mm, where 0 indicates no pain and 10 indicates the worst imaginable pain).
A single VAS score will be recorded during the intraoperative period.
|
Intraoperative period (during the procedure)
|
|
Patient satisfaction with nursing care (Newcastle Satisfaction with Nursing Scale, NSNS)
Time Frame: Postoperative Day 1
|
Postoperative Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Mental Disorders
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Thyroid Neoplasms
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Carcinoma
- Thyroid Diseases
- Adenocarcinoma, Papillary
- Thyroid Cancer, Papillary
- Anxiety Disorders
Other Study ID Numbers
- 2509008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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