Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01318291
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2011-03-16
Brief Title:
Effect of Psychological Intervention on Drop-out Rates in IVF
Sponsor:
Boston IVF
Organization:
Boston IVF
Study Overview
Official Title:
An Assessment of the Effect of a Brief Psychological Intervention on Decreasing Drop-Out Rates in IVF Patients
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The most common reason why insured In Vitro Fertilization IVF patients drop out of treatment is the distress caused by the treatment
The objective of this study is to determine the efficacy of a combined Cognitive Coping and Relaxation Intervention CCRI in reducing drop out behavior in IVF patients
The objective of this study is to determine the efficacy of a combined Cognitive Coping and Relaxation Intervention CCRI in reducing drop out behavior in IVF patients
Detailed Description:
Intervention participants will be given a packet containing the CCRI which consists of two intervention components tailored to the Stimulation Phase and Waiting Phases of IVF The cognitive component of the CCRI is the PRCI intervention Boivin Lancastle 2008 tailored to the stimulationwaiting phases of an IVF cycle The PRCI intervention consists of a series of ten statements that facilitate the use of cognitive reappraisal coping a form of coping that helps people think more about the positive aspects of a difficult situation and dwell less on problems or uncertainties of the future
The relaxation components of the CCRI consists of techniques that have been used for two decades in the mindbody infertility program as well as in randomized controlled research trials For the Stimulation phase participants will receive instructions on how to do mini relaxation techniques which are specifically designed to reduce anxiety in the moment for example feelings of tension worry and nervousness that might occur prior to and during Stimulation phase procedures eg injections blood tests and ultrasounds For the Waiting Phase the relaxation intervention will include a relaxation CD The CD contains narrated instruction on how to elicit the relaxation response through several techniques
This is a randomized controlled prospective study conducted at a private academically-affiliated infertility clinic and includes women ages 44 and below scheduled to undergo their first IVF cycle Subjects are randomized to a CCRI or a control group The primary outcome measure is dropout rates
The relaxation components of the CCRI consists of techniques that have been used for two decades in the mindbody infertility program as well as in randomized controlled research trials For the Stimulation phase participants will receive instructions on how to do mini relaxation techniques which are specifically designed to reduce anxiety in the moment for example feelings of tension worry and nervousness that might occur prior to and during Stimulation phase procedures eg injections blood tests and ultrasounds For the Waiting Phase the relaxation intervention will include a relaxation CD The CD contains narrated instruction on how to elicit the relaxation response through several techniques
This is a randomized controlled prospective study conducted at a private academically-affiliated infertility clinic and includes women ages 44 and below scheduled to undergo their first IVF cycle Subjects are randomized to a CCRI or a control group The primary outcome measure is dropout rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None