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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Behavioral: follow the WeChat public platform to watch the education videos; Behavioral: regular preoperative visits and education by ward nurses.

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.

• Study Type: Interventional
• Enrollment (Actual): 392
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WeChat group; The 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.	Behavioral: follow the WeChat public platform to watch the education videos; In addition to the regular preoperative visits, the WeChat education group will watch science videos through WeChat before the surgical procedures.
Placebo Comparator: Regular group; Patients 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.	Behavioral: regular preoperative visits and education by ward nurses.; received oral instruction from the ward nurse covering the same contents as above instead of the education video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The day before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The day before and at 72 hours after surgery
incidence of anxiety 72 hours after surgery	Subjects will be assessed for anxiety on 1day before and at 72 hours after surgery	at 72 hours after surgery
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.	at 24，48 , 72 hours after surgery
incidence of PONV within 24 hours after surgery	the investigators considered it PONV if patients felt any nausea or had any vomiting	during the first 24 hours after surgery
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.	At 1 week after surgery
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.	at 1 and 3 months after surgery

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 28, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: periperative anxiety
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020-1138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No