- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07707401
Effectiveness of WeChat-Supported Neck Rehabilitation Exercises on Early Recovery After Thyroidectomy
9. september 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ling Zhan, Dr
- Telefonnummer: +8615821120972
- E-mail: rebecca0428zhan@163.com
Studiesteder
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200233
- Rekruttering
- Shanghai Sixth People's Hospital
-
Kontakt:
- Ling Zhan, Doctor
- Telefonnummer: 08615821120972
- E-mail: rebecca0428zhan@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: WeChat-supported tele-rehabilitation group
Participants in the WeChat-supported tele-rehabilitation group received WeChat mini program-supported postoperative neck exercise management.
|
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.
|
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Neck Pain and Disability Scale (NPDS) Score
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neck Movement Pain Score
Tidsramme: Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
|
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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Rehabilitation adherence
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. september 2026
Primær færdiggørelse (Anslået)
31. december 2028
Studieafslutning (Anslået)
30. juni 2029
Datoer for studieregistrering
Først indsendt
13. juli 2026
Først indsendt, der opfyldte QC-kriterier
13. juli 2026
Først opslået (Faktiske)
16. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Smerte
- Neurologiske manifestationer
- Sygdomme i det endokrine system
- Postoperative komplikationer
- Patologiske processer
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer i endokrine kirtler
- Neoplasmer i hoved og hals
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Skjoldbruskkirtelsygdomme
- Smerter, postoperativ
- Thyroidneoplasmer
Andre undersøgelses-id-numre
- 2026-KY-277(K)
Plan for individuelle deltagerdata (IPD)
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