the Psychological Interventions for Alleviating Anxiety and Depressive Emotion Among Oocyte Retrieval Patients
NCT ID: NCT06475690
Last Updated: 2024-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
180 participants
INTERVENTIONAL
2024-06-25
2025-07-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AC group
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.
Psychological interventions
Psychological interventions is used for intervention group
CON group
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.
No interventions assigned to this group
Interventions
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Psychological interventions
Psychological interventions is used for intervention group
Eligibility Criteria
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Inclusion Criteria
* able to use smartphone to complete questionnaire
Exclusion Criteria
* 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
20 Years
50 Years
FEMALE
No
Sponsors
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First Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Qibin Chen
associate professor
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CQB2
Identifier Type: -
Identifier Source: org_study_id
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