the Psychological Interventions for Alleviating Anxiety and Depressive Emotion Among Oocyte Retrieval Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- First Affiliated Hospital of Chongqing Medical University
- Enrollment
- 180
- Primary Endpoint
- The difference in incidence of anxiety 1 hour before operation between the two groups
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trial is to learn if psychological interventions alleviate the anxious emotion of women undergoing oocyte retrieval operation with general anesthesia.
The main questions it aims to answer are:
If psychological interventions reduced participants' anxiety scores before the oocyte retrieval operation. Researchers will compare psychological interventions to no interventions to see if psychological interventions work to alleviate anxious emotion. Questionnaires related anxiety were completed online before surgery by participants.
Investigators
Qibin Chen
associate professor
First Affiliated Hospital of Chongqing Medical University
Eligibility Criteria
Inclusion Criteria
- •underwent oocyte retrieval operation with general anesthesia
- •able to use smartphone to complete questionnaire
Exclusion Criteria
- •had major psychological trauma, schizophrenia
- •morbid obesity (BMI greater than 40.0 kg/m2.)
- •serious disease of cardiovascular system including uncontrolled hypertension
- •serious endocrine system disease including uncontrolled hypothyroidism
- •history of severe adverse events related to anesthesia
- •history of substance abuse or severe allergy
- •refusal to provide written consent
Outcomes
Primary Outcomes
The difference in incidence of anxiety 1 hour before operation between the two groups
Time Frame: Each patient is assessed by APAIS for two times. The first time is 24 hours before surgery, and the second time is 1 hour before surgery.
The degree of anxiety was measured by the Amsterdam Preoperative Anxiety and Information Scale and it is abbreviated as APAIS in the Primary Outcome. This is a six-item questionnaire. Every item is graded on a five-point scale from 1(meaning not at all) to 5 (meaning extremely). The scoring range of this scale is from 6 to 30 points, with a cutoff point of 11. Specifically, a score of ≤10 indicates no anxiety, while a score of ≥11 indicates anxiety. Each patient received two APAIS assessments, 24 hours before and 1 hour before surgery respectively. After the second assessment, the number of anxious patients in each group was calculated based on the APAIS scores. Then, the number of anxious patients divided by the total number of patients in the group is the incidence of anxiety. Finally, a statistical comparison was made to determine if there is a significant difference in incidence of anxiety between the two groups of patients.
Secondary Outcomes
- the comparison of postoperative PHQ-9 scores between two groups(Each patient is assessed by PHQ-9 twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of incidence of postoperative anxiety between two groups(Each patient is assessed by GAD-7 twice.The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of postoperative GAD-7 scores between two groups(Each patient is assessed by GAD-7 twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of incidence of postoperative depression in two groups(Each patient is assessed by PHQ-9 twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of postoperative HADS scores between two groups(Each patient is assessed by HADS twice. The first time is 24 hours before surgery, and the second time is 24~48 hours after surgery.)
- the comparison of APAIS score in two group 1h before operation(Each patient is assessed by APAIS for two times. The first time is 24 hours before surgery, and the second time is 1 hour before surgery.)