the Psychological Interventions for Alleviating Anxiety and Depressive Emotion Among Oocyte Retrieval Patients

NCT06475690 | Completed

• 1 other identifier: CQB2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

in Vitro Fertilization; Mental Health; Anesthesia, General; Infertility

Keywords

oocyte retrieval; Anxiety symptoms; depression symptoms; psychological intervention; intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• 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 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.

Study Arms (2)

AC group

EXPERIMENTAL

AC group (active communication group): Prior to oocyte retrieval 24h, anesthesiologist and patient sign an informed consent form for anesthesia, then anxiety and depressive symptoms are assessed by scales including APAIS, GAD-7, PHQ-9 and HAD. This is the first score for all questionnaire. Subsequently, active communication will be performed, including addressing surgical procedures, anesthesia processes, and potential complications. No matter whether the patient asks the anesthesiologist about surgery and anesthesia or not, the active communication will be provided. One hour before surgery, patients' anxiety will be reassessed using APAIS. This is the second score for APAIS. Anxiety and depressive symptoms will be evaluated by GAD-7, PHQ-9 and HAD between 24 to 48 hours after oocyte retrieval operation. This is the second score for GAD-7, PHQ-9 and HAD.

Other: Psychological interventions

CON group

NO INTERVENTION

CON group (control group): Prior to oocyte retrieval 24h, anesthesiologist and patient sign an informed consent form for anesthesia, then anxiety and depressive symptoms are assessed by scales including APAIS, GAD-7, PHQ-9 and HAD. This is the first score for all questionnaire. If a patient doesn't ask any question about surgery or anesthesia, no interpretation will be provided. That is to say, the anesthesiologist will not actively communicate with the patient about surgical and anesthesia issues. One hour before surgery, patients' anxiety will be reassessed using APAIS. This is the second score for APAIS. Anxiety and depressive symptoms will be evaluated by GAD-7, PHQ-9 and HAD between 24 to 48 hours after oocyte retrieval operation. This is the second score for GAD-7, PHQ-9 and HAD.

Interventions

Psychological interventions OTHER

Psychological interventions is used for intervention group

AC group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• underwent oocyte retrieval operation with general anesthesia
• able to use smartphone to complete questionnaire

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (7)

• Liu YF, Fu Z, Chen SW, He XP, Fan LY. The Analysis of Anxiety and Depression in Different Stages of in vitro Fertilization-Embryo Transfer in Couples in China. Neuropsychiatr Dis Treat. 2021 Feb 25;17:649-657. doi: 10.2147/NDT.S287198. eCollection 2021.

  PMID: 33658786 BACKGROUND

• Li G, Jiang Z, Kang X, Ma L, Han X, Fang M. Trajectories and predictors of anxiety and depression amongst infertile women during their first IVF/ICSI treatment cycle. J Psychosom Res. 2021 Mar;142:110357. doi: 10.1016/j.jpsychores.2021.110357. Epub 2021 Jan 16.

  PMID: 33508704 BACKGROUND

• Braverman AM, Davoudian T, Levin IK, Bocage A, Wodoslawsky S. Depression, anxiety, quality of life, and infertility: a global lens on the last decade of research. Fertil Steril. 2024 Mar;121(3):379-383. doi: 10.1016/j.fertnstert.2024.01.013. Epub 2024 Jan 13.

  PMID: 38224730 BACKGROUND

• Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.

  PMID: 8623940 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

MeSH Terms

Conditions

Infertility; Psychological Well-Being; Anxiety Disorders; Depression

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 26, 2024
• Study Start: September 8, 2024
• Primary Completion: June 24, 2025
• Study Completion: July 10, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)