Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing IVF-ET

Infertility Clinical Trial

Official title:

Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing In Vitro Fertilization-Embryo Transfer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931187
• Other study ID #: Intervention on IVF-ET
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: November 2021
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The in vitro fertilization and embryo transfer(IVF-ET) is a therapy to help the infertile couples. The mental health status of couple under IVF-ET, commonly seen in depression and anxiety, is found to be closely related to the success of IVF-ET. This study aims to develop a intervention program combing cognitive psychotherapy and progressive muscle relaxation to ease the negative emotion and promote the success rate among couples undergoing IVF-ET.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The couple who are eligible for in vitro fertilization-embryo transfer (IVF-ET) treatment;
• Junior high school and above;
• voluntarily accepted for investigation and signed informed consent.

Exclusion Criteria:

• Suffering from physical diseases such as severe heart, liver and kidney, and mental disorders;
• Experiencing major traumatic events in the past 2 years.

Related Conditions & MeSH terms

• Infertility

Intervention

Behavioral:
• Cognitive progressive muscular relaxation therapy
This therapy combines cognitive psychotherapy and progressive muscular relaxation, intervened 6 times with 1-1.5 hour each time. The whole therapy will last round 28-30 days during IVF-ET.

Locations

Country	Name	City	State
China	Infertility Reproductive Center, Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of depression score	The Self-reported Depression Scale (SDS)will be used to assess the score of depression.The total score of SDS ranges from 0-80, with 40 as the cutoff. The higher the total score, the more depressive.	The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Primary	Change of anxiety score	The Self-reported Anxiety Scale (SAS) will be used to assess the score of anxiety.The total score of SAS ranges from 0-80, with 30 as the cutoff. The higher the total score, the more anxious.	The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Secondary	Change of Blood Cortisol	This is a kind of hormone closely related to stress, and the investigators will measure the level of Blood Cortisol by Blood test.	The investigators will measure the socre of Blood Cortisol at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Secondary	Change of sleeping quality	The physical condition closely related to stress. The investigators will use Self-Rating Scale of Sleep to measure the sleeping quality of the participants. The total sore ranges from 5 to 50, with higher score reflects better sleep quality.	The investigators will measure the socre of sleeping quality at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Secondary	Successful conception rate (%)	The investigators will count the successful conception rate at each arms.	The doctor will test whether it is successfully conceived 4 weeks after the embryo is implanted. The last intervention is on the day of embryo implantation. The investigators will count this 4 weeks after completion of intervention.