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

Sponsor
West China Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05291494
Collaborator
(none)
392
1
2
13.9
28.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: follow the WeChat public platform to watch the education videos
  • Behavioral: regular preoperative visits and education by ward nurses.
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
392 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Prevention
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
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. the incidence of preoperative anxiety [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 Outcome Measures

  1. 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]

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

  2. incidence of anxiety 72 hours after surgery [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 [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 [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)) [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 [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.

  7. incidence of chronic pain at 3 months postoperatively [at 3 months after surgery]

    The investigators also use numerical rating scale(NRS) to evaluate chronic pain. 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.

  8. Bowel function recovery [At 3 days after surgery]

    defined as the time to first defecation or time to first flatus

  9. Length of hospital stay [From the date of randomization to the date of discharge for any reason,an average of 7 days]

    determined by the number of days from admittance to discharge

  10. hospitalization expenses [From the date of randomization to the date of discharge for any reason,an average of 7 days]

    The total cost of this hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital Chengdu Sichuan China 610041

Sponsors and Collaborators

  • West China Hospital

Investigators

  • Study Director: Chunling Jiang, PhD, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chunling Jiang, Professor, West China Hospital
ClinicalTrials.gov Identifier:
NCT05291494
Other Study ID Numbers:
  • 2020-1138
First Posted:
Mar 22, 2022
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chunling Jiang, Professor, West China Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2022