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

Breast Cancer Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291494
• Other study ID #: 2020-1138
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2022
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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