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

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Cognitive progressive muscular relaxation therapy

About this trial

This is an interventional supportive care trial for Infertility focused on measuring cognitive psychotherapy, progressive muscular relaxation, in vitro fertilization and embryo transfer(IVF-ET), Couples Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Infertility Reproductive Center, Second Xiangya Hospital, Central South University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Women intervention arm

Couple intervention arm

Control arm

Arm Description

Intervention will be applied to the women within the couple.

Intervention will be applied to the couple, both men and women.

The couple will receive the normal nursing care.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Successful conception rate (%)

The investigators will count the successful conception rate at each arms.

Full Information

NCT ID

NCT03931187

First Posted

April 23, 2019

Last Updated

November 30, 2021

Sponsor

Central South University

1. Study Identification

Unique Protocol Identification Number

NCT03931187

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

May 1, 2019 (Actual)

Study Completion Date

July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

cognitive psychotherapy, progressive muscular relaxation, in vitro fertilization and embryo transfer(IVF-ET), Couples Therapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Women intervention arm

Arm Type

Experimental

Arm Description

Intervention will be applied to the women within the couple.

Arm Title

Couple intervention arm

Arm Type

Experimental

Arm Description

Intervention will be applied to the couple, both men and women.

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

The couple will receive the normal nursing care.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive progressive muscular relaxation therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of depression score

Description

Time Frame

The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month).

Title

Change of anxiety score

Description

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.

Time Frame

The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month).

Secondary Outcome Measure Information:

Title

Change of Blood Cortisol

Description

This is a kind of hormone closely related to stress, and the investigators will measure the level of Blood Cortisol by Blood test.

Time Frame

The investigators will measure the socre of Blood Cortisol at baseline and immediately after intervention ( the duration of intervention is around 1 month).

Title

Change of sleeping quality

Description

Time Frame

The investigators will measure the socre of sleeping quality at baseline and immediately after intervention ( the duration of intervention is around 1 month).

Title

Successful conception rate (%)

Description

The investigators will count the successful conception rate at each arms.

Time Frame

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.

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Biological sex

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Infertility Reproductive Center, Second Xiangya Hospital, Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The participants are not willing to share the data.

Learn more about this trial

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

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