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

NCT05291494 | Completed

• 1 other identifier: 2020-1138
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

periperative anxiety

Outcome Measures

Primary Outcomes (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.

  The day before surgery

Secondary Outcomes (6)

• incidence of severe anxiety (S-AI > 44) 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

  at 72 hours after surgery

• NRS scores for pain at rest and during movement

  at 24，48 , 72 hours after surgery

• incidence of PONV within 24 hours after surgery

  during the first 24 hours after surgery

• subjective sleep score (Sleep Quality Score (SQS))

  At 1 week after surgery

Study Arms (2)

WeChat group

EXPERIMENTAL

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

Regular group

PLACEBO COMPARATOR

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.

Interventions

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.

WeChat group

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.

Regular group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 38570855 DERIVED

Study Officials

• Chunling Jiang, PhD

  West China Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, the anesthesiologist, data collectors, the physicians performing the follow-up, and data analysts will be blinded to the group allocation. Blinding will maintain until the completion of the final analyses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: March 22, 2022
• Study Start: February 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)