- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07707401
Effectiveness of WeChat-Supported Neck Rehabilitation Exercises on Early Recovery After Thyroidectomy
9. september 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ling Zhan, Dr
- Telefonnummer: +8615821120972
- E-post: rebecca0428zhan@163.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200233
- Rekruttering
- Shanghai Sixth People's Hospital
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Ta kontakt med:
- Ling Zhan, Doctor
- Telefonnummer: 08615821120972
- E-post: rebecca0428zhan@163.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Neck Movement Pain Score
Tidsramme: 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
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. september 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
30. juni 2029
Datoer for studieregistrering
Først innsendt
13. juli 2026
Først innsendt som oppfylte QC-kriteriene
13. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Sykdommer i det endokrine systemet
- Postoperative komplikasjoner
- Patologiske prosesser
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer i endokrine kjertel
- Neoplasmer i hode og nakke
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Skjoldbrusk sykdommer
- Smerter, postoperativt
- Neoplasmer i skjoldbruskkjertelen
Andre studie-ID-numre
- 2026-KY-277(K)
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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