Clinical trial NCT05291494: A Study on the Effectiveness of WeChat-based Online Education to Reduce Perioperative Anxiety in Breast Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: periperative anxiety
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 392
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the incidence of preoperative anxiety
timeFrame: The day before surgery
Secondary outcomes:
measure: incidence of severe anxiety (S-AI > 44) on 1day before and at 72 hours after surgery
timeFrame: The day before and at 72 hours after surgery
measure: incidence of anxiety 72 hours after surgery
timeFrame: at 72 hours after surgery
measure: NRS scores for pain at rest and during movement
timeFrame: at 24，48 , 72 hours after surgery
measure: incidence of PONV within 24 hours after surgery
timeFrame: during the first 24 hours after surgery
measure: subjective sleep score (Sleep Quality Score (SQS))
timeFrame: At 1 week after surgery
measure: quality of life QoR-15 scores at 1 and 3 months postoperatively
timeFrame: at 1 and 3 months after surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Chunling Jiang, PhD
role: STUDY_DIRECTOR
References: