NCT07302672

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

November 29, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

November 29, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

papillary thyroid carcinomathermal ablationhumanistic carecontinuity careWechatanxietyquality of life

Outcome Measures

Primary Outcomes (3)

  • Change in emotion distress from baseline to post-procedure (HADS)

    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

    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

    From enrollment to 3 months after end of treatment

Secondary Outcomes (2)

  • Intraoperative pain intensity (Visual Analog Scale)

    Intraoperative period (during the procedure)

  • Patient satisfaction with nursing care (Newcastle Satisfaction with Nursing Scale, NSNS)

    Postoperative Day 1

Study Arms (2)

Humanistic Continuing Care via WeChat

EXPERIMENTAL
Behavioral: Humanistic Continuing Care via WeChat

Usual Care (No Structured WeChat Program)

ACTIVE COMPARATOR
Procedure: Usual Care (No Structured WeChat Program)

Interventions

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.

Humanistic Continuing Care via WeChat

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.

Usual Care (No Structured WeChat Program)

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, PapillaryAnxiety Disorders

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesMental Disorders

Central Study Contacts

ming-an yu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Personnel responsible for evaluating the primary or secondary outcome measures remain unaware of the participants' group assignments.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of department of intervention medicine

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 24, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 24, 2025

Record last verified: 2025-12

Locations