the Psychological Interventions for Alleviating Anxiety and Depressive Emotion Among Oocyte Retrieval Patients
NCT Number: NCT06475690
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility|in Vitro Fertilization|Mental Health|Anesthesia, General
Interventions: OTHER: Psychological interventions
Sponsor: First Affiliated Hospital of Chongqing Medical University
Sex: FEMALE
Age: ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-25
Completion Date: 2025-07-10

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.

Primary Outcome Measures: The difference in incidence of anxiety 1 hour before operation between the two groups, 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., 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.
Secondary Outcome Measures: the comparison of APAIS score in two group 1h before operation, The degree of anxiety is measured by the Amsterdam Preoperative Anxiety and Information Scale and it is abbreviated as APAIS in the outcome. This is a six-item questionnaire. Every item is graded on a five-point scale from 1( not at all) to 5 (extremely). The score 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 evaluation about APAIS, the comparison of APAIS scores is fulfilled to determine if there is a significant difference among the two groups., 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 comparison of incidence of postoperative anxiety between two groups, The anxiety is measured by the Generalized anxiety disorder 7- item scale, a seven-item questionnaire, which is abbreviated as GAD-7. Every item is graded on a 4-point scale from 0 to 3. 0,1,2 and 3 stand for not at all, several days, more than half the days and nearly every day respectively. The total score ranges from 0 to 21 and 0-4, 5-9, 10-14, and 15-21 represent minimal, mild, moderate, and severe levels of anxiety respectively. A score of ≤4 represents no anxiety, while a score of ≥5 indicates the presence of anxiety. Each patient is assessed by GAD-7 twice, 24 hours before and 24\~48 hours after surgery respectively. After the second GAD-7 rating, the number of anxious people and incidence of postoperative anxiety are calculated in each group and according to the GAD-7 score. Finally, a statistical comparison is made to determine whether there is a significant difference in incidence of postoperative anxiety between the two groups of patients., 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, The degree of anxiety was measured by the Generalized anxiety disorder 7- item scale and it is abbreviated as GAD-7 in this outcome. This is a seven-item questionnaire. Every item is graded on a 4-point scale from 0 to 3. 0,1,2 and 3 stand for not at all, several days, more than half the days and nearly every day respectively. The total score of this scale ranges from 0 to 21, where 0-4, 5-9, 10-14, and 15-21 represent minimal, mild, moderate, and severe levels of anxiety respectively. That means a score of ≤4 represents no anxiety, while a score of ≥5 indicates the presence of mild anxiety or higher-level anxiety. After the second GAD-7 rating, GAD-7 scores between the two groups of patients are compared to determine whether there is a statistical difference., 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, The depression is measured by the Patient Health Questionnaire 9-item scale, a nine-item questionnaire, which is abbreviated as PHQ-9. Every item is graded on a 4-point scale from 0 to 3. 0,1,2 and 3 stand for not at all, several days, more than half the days and nearly every day respectively. The total score of this scale ranges from 0 to 27, where 0-4, 5-9, 10-14, 15-20 and 21-27 represent minimal, mild, moderate, moderately severe and severe levels of depression respectively. That means a score of ≤4 represents no depression, and a score of ≥5 indicates the presence of depression. Each patient is assessed by PHQ-9 twice, 24 hours before and 24\~48 hours after surgery respectively. After the second PHQ-9 rating, the incidence of depression is calculated in each group according to the PHQ-9 score. Finally, a statistical comparison is made to determine whether there is a significant difference in the incidence of postoperative depression between the two groups of patients., 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 PHQ-9 scores between two groups, The degree of depression is measured by the Patient Health Questionnaire 9-item scale and it is abbreviated as PHQ-9 in this outcome. This is a nine-item questionnaire. Every item is graded on a 4-point scale from 0 to 3. 0,1,2 and 3 stand for not at all, several days, more than half the days and nearly every day respectively. The total score of this scale ranges from 0 to 27, where 0-4, 5-9, 10-14, 15-20 and 21-27 represent minimal, mild, moderate, moderately severe and severe levels of depression respectively. That means a score of ≤4 represents no anxiety, while a score of ≥5 indicates the presence of mild depression or higher-level depression. Each patient is assessed by PHQ-9 two times, 24 hours before surgery and 24\~48 hours after surgery respectively. After the second PHQ-9 rating, PHQ-9 scores between the two groups of patients are compared to determine whether there was a statistical difference., 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, The Hospital Anxiety and Depression Scale can be used to measure anxiety and depression and it is abbreviated as HADS in this outcome. This is a 14-item questionnaire. Assessment of the overall severity of anxiety and depression are both rated on four-point (0-3) scales by the researchers. HADS includes two subscales the depression subscale and the anxiety subscale. The total score of this scale ranges from 0 to 21 for each subscale. For the depression subscale it is found that a score of 7 or less for no depressive cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases combined with depression. The scoring range of anxiety subscale is the same as that of depression subscale. Each patient is assessed by HADS two times, 24 hours before surgery and 24\~48 hours after surgery respectively. After the second HADS rating, HADS scores between the two groups of patients are compared to determine whether there was a statistical difference., 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.