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NCT Number: NCT05291494

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

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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

follow the WeChat public platform to watch the education videos

Behavioral

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.

Behavioral

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

Primary outcomes

  1. the incidence of preoperative anxiety

    Time frame: The day before surgery

    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.

Secondary outcomes

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

    Time frame: The day before and at 72 hours after surgery

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

  2. incidence of anxiety 72 hours after surgery

    Time frame: at 72 hours after surgery

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

  3. NRS scores for pain at rest and during movement

    Time frame: at 24，48 , 72 hours after surgery

    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.

  4. incidence of PONV within 24 hours after surgery

    Time frame: during the first 24 hours after surgery

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

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

    Time frame: At 1 week after surgery

    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.

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

    Time frame: at 1 and 3 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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