NCT04571736

Brief Summary

The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient. There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time. The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Nov 2020

Longer than P75 for not_applicable

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 Progress86%
Nov 2020Mar 2027

First Submitted

Initial submission to the registry

July 27, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 18, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2027

Last Updated

January 21, 2025

Status Verified

January 1, 2025

Enrollment Period

6 years

First QC Date

July 27, 2020

Last Update Submit

January 17, 2025

Conditions

Thyroid

Keywords

Preoperative ProcedureInstructional Films and Video

Outcome Measures

Primary Outcomes (1)

  • Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE

    rate of patients with perioperative anxiety symptoms refind by APAIS SCORE \>= 11. Rate from 1 (absent) to 5 (extrem). Score 2 to 4 : rejection of information, 5 to 7 : medium desire for information, \> 7 : hungry for information.

    Baseline Day [-90 / -7] and Surgery Day [-1 / 0]

Secondary Outcomes (7)

  • State-Trait Anxiety Inventory (STAI-ETAT) SCORE

    Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30]

  • Internet use self-questionnaire

    Baseline Day [-90 / -7]

  • Internet use self-questionnaire

    Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30]

  • specific questionnaire EDOP

    post-operative visit Day [5-30] after viewing the screening video

  • satisfaction assessment questionnaire and understanding of the preoperative medical information for control group

    Baseline Day [-90 / -7], Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]

  • +2 more secondary outcomes

Study Arms (2)

access to the internet information platform

ACTIVE COMPARATOR

usual preoperative information and access to the internet information platform

Other: access to the internet information platform

usual preoperative information

NO INTERVENTION

medical information delivered to the patient before any surgery

Interventions

access to the internet information platformOTHER

This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time.

access to the internet information platform

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75,
  • Indication of lobo-isthmectomy or total thyroidectomy
  • Compliance for the completion of self-questionnaires
  • Person affiliated or beneficiary of a social security scheme.

You may not qualify if:

  • Difficulty understanding the French language
  • Lack of internet access
  • Persons placed under the protection of justice,
  • Person under guardianship or curatorship
  • Subject with severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant
  • Pregnant / lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Gui de Chauliac

Montpellier, Hérault, 34295, France

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Cesar Cartier, PI

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cesar Cartier, PI

CONTACT

0467336895c-cartier@chu-montpellier.fr

Susana Leornard, CRA

CONTACT

04 67 33 61 56s-leonard@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

October 1, 2020

Study Start

November 18, 2020

Primary Completion (Estimated)

November 18, 2026

Study Completion (Estimated)

March 18, 2027

Last Updated

January 21, 2025

Record last verified: 2025-01

Locations

FR(1)