- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07707401
Effectiveness of WeChat-Supported Neck Rehabilitation Exercises on Early Recovery After Thyroidectomy
9 september 2026 uppdaterad av: Ling Zhan, Shanghai 6th People's Hospital
Effectiveness of WeChat-Supported Neck Rehabilitation Exercises on Early Recovery After Thyroidectomy: A Randomized Controlled Trial
This study aimed to evaluate the effectiveness, safety, and implementation outcomes of a WeChat mini program-supported tele-neck rehabilitation exercises for improving early postoperative neck recovery after thyroidectomy.
Studieöversikt
Status
Rekrytering
Studietyp
Interventionell
Inskrivning (Beräknad)
200
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ling Zhan, Dr
- Telefonnummer: +8615821120972
- E-post: rebecca0428zhan@163.com
Studieorter
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200233
- Rekrytering
- Shanghai Sixth People's Hospital
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Kontakt:
- Ling Zhan, Doctor
- Telefonnummer: 08615821120972
- E-post: rebecca0428zhan@163.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Undergoing thyroid surgery
- Postoperative condition stable, with the attending physician assessing the patient as fit for neck movement
- Willing to participate in the study, complete scheduled follow-ups, and sign a written informed consent form
Exclusion Criteria:
- History of prior thyroid or neck surgery
- History of cervical spondylosis, cervical spine surgery, neck trauma, or other conditions affecting neck mobility
- Postoperative complications rendering the patient unsuitable for neck movement training, such as confirmed recurrent laryngeal nerve injury, chyle leak, or complications requiring reoperation or prolonged drainage, or incision infection
- Persistent postoperative dizziness or other conditions unsuitable for exercise
- Unable to use WeChat and lacking assistance from family members
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: WeChat-supported tele-rehabilitation group
Participants in the WeChat-supported tele-rehabilitation group received WeChat mini program-supported postoperative neck exercise management.
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WeChat mini program-supported neck exercise management includes daily exercise reminders, exercise check-ins, symptom reporting, automated abnormal symptom prompts, and standardized remote feedback from the research team.
This intervention consists of standard clinical postoperative care and discharge education, encompassing wound management, follow-up appointments, and generic neck activity guidelines.
Prior to discharge or upon clinical stability, participants undergo a one-time, face-to-face training session with research staff featuring practical exercise demonstrations and behavioral precautions, and are provided with identical instructional video materials for home reference.
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Aktiv komparator: Routine care group
Participants in the routine care group did not receive WeChat mini program-supported postoperative neck exercise management.
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This intervention consists of standard clinical postoperative care and discharge education, encompassing wound management, follow-up appointments, and generic neck activity guidelines.
Prior to discharge or upon clinical stability, participants undergo a one-time, face-to-face training session with research staff featuring practical exercise demonstrations and behavioral precautions, and are provided with identical instructional video materials for home reference.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Neck Pain and Disability Scale (NPDS) Score
Tidsram: Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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The NPDS is used to evaluate post-surgical neck pain and its multi-dimensional impact on daily living, emotions, work, and social activities.
The total score ranges from 0 to 100, with higher scores representing more severe neck pain and structural functional impairment.
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Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Neck Movement Pain Score
Tidsram: Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Assessment of localized pain severity provoked during active cervical movements, including neck flexion, extension, left/right lateral flexion, and left/right rotation.
Each of the six movements is scored categorically as 0 (painless), 1 (mild pain), or 2 (severe pain), yielding a cumulative score range of 0 to 12. Higher total scores indicate more pronounced motion-induced cervical pain.
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Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Health-related quality of life
Tidsram: Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
The descriptive system assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five response levels for each dimension.
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Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Incidence of Surgical Complications and Intervention-Related Adverse Events
Tidsram: Up to 3 month post-operation
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Safety endpoints mapping the frequency and severity of post-surgical complications (e.g., wound bleeding/hematoma, incision dehiscence, surgical site infection) or any adverse events deemed by the investigator to be potentially related to the physical exercise regimen (e.g., severe motion-induced pain exacerbation, acute dizziness).
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Up to 3 month post-operation
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Cervical Range of Motion (ROM)
Tidsram: Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Objective clinical measurement of neck mobility, quantifying the exact degrees of cervical movement achieved during forward flexion, backward extension, left/right lateral flexion, and left/right rotation, assessed by a blinded investigator.
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Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Rehabilitation adherence
Tidsram: Up to 1 month post-operation
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Adherence will be calculated as the number of completed prescribed rehabilitation sessions divided by the number of prescribed sessions during the corresponding assessment period, multiplied by 100%.
Higher percentages indicate better adherence.
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Up to 1 month post-operation
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Acceptability of postoperative rehabilitation
Tidsram: 30 days after drainage removal
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Acceptability of the postoperative rehabilitation program will be assessed using study-specific items addressing clarity of the rehabilitation guidance, usefulness of the educational materials, suitability, perceived safety, burden, confidence in recovery, overall satisfaction, and willingness to recommend the rehabilitation approach.
Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
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30 days after drainage removal
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 september 2026
Primärt slutförande (Beräknad)
31 december 2028
Avslutad studie (Beräknad)
30 juni 2029
Studieregistreringsdatum
Först inskickad
13 juli 2026
Först inskickad som uppfyllde QC-kriterierna
13 juli 2026
Första postat (Faktisk)
16 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Smärta
- Neurologiska manifestationer
- Sjukdomar i det endokrina systemet
- Postoperativa komplikationer
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer i endokrina körtel
- Neoplasmer i huvud och hals
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Sköldkörtelsjukdomar
- Smärta, postoperativt
- Sköldkörtelneoplasmer
Andra studie-ID-nummer
- 2026-KY-277(K)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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