the Psychological Interventions for Alleviating Anxiety and Depressive Emotion Among Oocyte Retrieval Patients
Phase: NA
Conditions: Infertility, in Vitro Fertilization, Mental Health, Anesthesia, General
Sponsor: First Affiliated Hospital of Chongqing Medical University

Official title:
Impact of Personalized Preoperative Psychological Intervention on
Perioperative Anxiety and Depression in Patients Undergoing Oocyte
Retrieval: A Randomised Controlled Study
NCT number: NCT06475690
Document date: 2024-07-02

Study design and Statistical analysis
This is a prospective, single-blind, randomized controlled trial conducted at the
Reproductive Medicine Center of the First Affiliated Hospital of Chongqing Medical
University from September 8, 2024 to June 24, 2025 (registration number:
NCT06475690). It was approved by the ethics committee and written informed
consent was obtained from all participants.
Study Population: 179 valid female patients scheduled for oocyte retrieval under
general anesthesia were included, aged 20 – 44 years and able to complete
questionnaires via smartphone. Exclusion criteria included psychiatric disorders,
morbid
obesity,
severe
cardiovascular/endocrine
diseases,
history
of
serious
anesthesia-related adverse events, etc.
Interventions: Participants were randomized 1:1 into two groups:
Active Communication Group (AC Group): Received individualized pre-anesthesia
communication from an anesthesiologist, addressing concerns, providing tailored
information, and offering emotional support.
Control Group (CON Group): Received routine pre-anesthesia communication, which
only informed patients of potential risks and standard management protocols.
Measures & Time Points:
APAIS: Assessed preoperative anxiety and information needs at 24 h before surgery
and 1 h preoperatively.
GAD-7, PHQ-9, HADS: Evaluated anxiety and depressive symptoms at 24 h
preoperatively and 24–48 h postoperatively.
Anesthesia & Perioperative Care: Standardized intravenous anesthesia with
propofol and remifentanil was used, with intraoperative monitoring of BIS and vital
signs. Postoperatively, pain and nausea/vomiting were managed in the PACU
according to VAS scores and clinical guidelines.
Sample Size & Statistics: The required sample size was 170, and 180 participants
were enrolled (179 valid) to account for 5% loss to follow-up. Statistical analyses
were performed using SPSS 26.0: baseline comparisons used t-test/Mann-Whitney U

test/χ² test; the primary outcome was analyzed by ANCOVA, with a two-sided α
of 0.05 considered statistically significant.