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Breast Cancer FemaleNCT05291494

A Study on the Effectiveness of WeChat-based Online Education to Reduce Perioperative Anxiety in Breast Cancer Patients

A study testing follow the WeChat public platform to watch the education videos and regular preoperative visits and education by ward nurses. in people with Breast Cancer Female, run by West China Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients who meet the enrollment criteria will be randomly assigned to the WeChat education group and the regular group. In addition to the regular preoperative visits, the WeChat education group will also watch science videos through WeChat before the surgical procedures. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
follow the WeChat public platform to watch the education videos and regular preoperative visits and education by ward nurses.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
392 participants
Where
1 siteChina
Study dates
1 Feb 2021to 31 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • female patients scheduled for elective breast cancer resection;
  • aged 18 to 80 years,;
  • American Society of Anesthesiologists (ASA) physical status I-III.

Who cannot join

  • patients diagnosed with primary breast cancer combined with malignant tumors of other organs (such as lung, kidney, intestine, etc.);
  • patients with tumor recurrence after reoperation;
  • patients failing to cooperate with the study for any reason, such as communication disorders.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: A Study on the Effectiveness of WeChat-based Online Education to Reduce Perioperative Anxiety in Breast Cancer Patients: a Prospective Randomized Controlled Study

Patients who meet the enrollment criteria will be randomly assigned to the WeChat education group and the regular group. In addition to the regular preoperative visits, the WeChat education group will also watch science videos through WeChat before the surgical procedures. The regular group only received regular preoperative visits and education by ward nurses. The main observation indicator is the incidence of preoperative anxiety defined as the scores of State Anxiety Inventory more than 40 points.

Read the detailed description

Patients who meet the inclusion criteria will be randomly assigned to the WeChat online education group or the regular group. Two researchers will conduct preoperative education, preoperative evaluation and postoperative follow-up respectively.The patients in WeChat group will be first assessed by a researcher on admission about anxiety and sleep (base on the State-Trait Anxiety Inventory (STAI) scale and the sleep quality scale (SQS)). Once the assessment completed, the patients are required to follow the WeChat public platform to watch the education videos when they are free. The content of the videos is jointly decided by the breast surgeon, anesthetists, and ward nurse including the overall prognosis, surgical approach, postoperative rehabilitation exercises, preparation for anesthesia, anesthesia approach and possible effects of anesthesia, which covers all aspects of surgery, anesthesia, and perioperative care. The videos are presented in an easy-to-understand pattern to ensure participants of all ages and levels of education comfortably understand the content. Participants can simply click on the video dialogue box in the public platform for playback and watch it unconditionally.Patients in regular group will be also assessed by the same researcher on admission for anxiety and sleep (base on State-Trait Anxiety Inventory (STAI) scale; sleep quality scale (SQS) scale). Upon completion of the assessment, they received oral instruction from the ward nurse covering the same contents as above instead of the education video.

Being tested
follow the WeChat public platform to watch the education videos, regular preoperative visits and education by ward nurses.
Keywords
periperative anxiety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • follow the WeChat public platform to watch the education videosBehavioural

    In addition to the regular preoperative visits, the WeChat education group will watch science videos through WeChat before the surgical procedures.

  • regular preoperative visits and education by ward nurses.Behavioural

    received oral instruction from the ward nurse covering the same contents as above instead of the education video.

Study groups in NCT05291494
Study groupRoleWhat they receive
WeChat groupExperimentalThe patients in this group will be first assessed by a researcher on admission about anxiety and sleep (base on the State-Trait Anxiety Inventory (STAI) scale and the sleep quality scale (SQS)). Once the assessment completed, the patients are required to follow the WeChat public platform to watch the education videos when they are free. The content of the videos covers all aspects of surgery, anesthesia, and perioperative care. The videos are presented in an easy-to-understand pattern to ensure participants of all ages and levels of education comfortably understand the content.
Receives: Behavioral: follow the WeChat public platform to watch the education videos
Regular groupPlacebo comparatorPatients in this group were also assessed by the same researcher on admission for anxiety and sleep (base on State-Trait Anxiety Inventory (STAI) scale; sleep quality scale (SQS) scale). Upon completion of the assessment, they received oral instruction from the ward nurse covering the same contents as above instead of the education video.
Receives: Behavioral: regular preoperative visits and education by ward nurses.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the incidence of preoperative anxiety

    The primary outcome indicator is the incidence of preoperative anxiety, defined as a S-AI(The State Anxiety Inventory)score of >40.The total S-AI score ranges from 20 to 80, with higher scores indicating more severe anxiety.When S-AI score exceeds 40, a state of clinical anxiety is confirmed25,26.A S-AI score outstripping 44 strongly denotes severe anxiety.

    Measured: The day before surgery

Secondary outcomes (6)

  1. incidence of severe anxiety (S-AI > 44) on 1day before and at 72 hours after surgery

    Subjects will be assessed for anxiety on 1day before and at 72 hours after surgery

    Measured: The day before and at 72 hours after surgery

  2. incidence of anxiety 72 hours after surgery

    Subjects will be assessed for anxiety on 1day before and at 72 hours after surgery

    Measured: at 72 hours after surgery

  3. NRS scores for pain at rest and during movement

    The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.

    Measured: at 24，48 , 72 hours after surgery

  4. incidence of PONV within 24 hours after surgery

    the investigators considered it PONV if patients felt any nausea or had any vomiting

    Measured: during the first 24 hours after surgery

  5. subjective sleep score (Sleep Quality Score (SQS))

    subjective sleep score(Sleep Quality Score (SQS)) at 1 week postoperatively.SQS is a self-assessment questionnaire with discrete visual analog scale (VAS). The questionnaire asked the respondents to score the overall sleep quality of the 7-day recall period on a discrete VAS scale. The respondents scored on the following five categories, with a score of 0 to 10:0 = bad, 1-3 = poor, 4-6 = fair, 7-9 = good and 10 = very good.

    Measured: At 1 week after surgery

  6. quality of life QoR-15 scores at 1 and 3 months postoperatively

    The investigators use the 15-item quality of recovery score (QoR-15 questionnaire) to reveal the life quality.QoR-15 consists of 15 questionnaires to assess patients' postoperative recovery, each of which is based on the pain rating scale and constructs an 11-point numerical rating scale. For positive items, 0 = never and 10 = always; For negative items, the score was reversed, and the final score was the sum of the 15 items, with the highest score being 150. The higher the score, the better the postoperative recovery.

    Measured: at 1 and 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2022
  2. Study start1 Feb 2021
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The experimental group will watch science videos through WeChat and regular preoperative visits before the surgical procedures. The regular group only received regular preoperative visits and education by ward nurses.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05291494
Sponsor's protocol ID
2020-1138
Status last verified
Aug 2022
First submitted
29 Dec 2021
Last updated
31 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xiao X, Zuo YD, Kuang SY, Liu CY, Kun-Shao, Wang H, Yan SY, Yu F, Xu Y, Zhou L, Jiang CL. Effectiveness of WeChat-assisted preoperative education to reduce perioperative anxiety in breast cancer patients: a prospective randomized controlled study protocol. Trials. 2024 Apr 3;25(1):231. doi: 10.1186/s13063-024-08071-3.

    PubMed 38570855

Questions about this trial

What is this clinical trial studying?

A study testing follow the WeChat public platform to watch the education videos and regular preoperative visits and education by ward nurses. in people with Breast Cancer Female, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the incidence of preoperative anxiety (time frame: The day before surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05291494, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.

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