Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing In Vitro Fertilization-Embryo Transfer Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Change of anxiety score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control arm
The couple will receive the normal nursing care.
Women intervention arm
Intervention will be applied to the women within the couple.
Intervention: Cognitive progressive muscular relaxation therapy (Behavioral)
Couple intervention arm
Intervention will be applied to the couple, both men and women.
Intervention: Cognitive progressive muscular relaxation therapy (Behavioral)
Outcomes
Primary Outcomes
Change of anxiety score
Time Frame: The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month).
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.
Change of depression score
Time Frame: The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month).
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.
Secondary Outcomes
- Change of sleeping quality(The investigators will measure the socre of sleeping quality at baseline and immediately after intervention ( the duration of intervention is around 1 month).)
- Successful conception rate (%)(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.)
- Change of Blood Cortisol(The investigators will measure the socre of Blood Cortisol at baseline and immediately after intervention ( the duration of intervention is around 1 month).)
Investigators
Anni Wang
Principal Investigator
Central South University