Stress Reduction During In Vitro Fertilization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00788502|
Recruitment Status : Unknown
Verified May 2010 by Stanford University.
Recruitment status was: Recruiting
First Posted : November 11, 2008
Last Update Posted : May 24, 2010
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Behavioral: Healing Touch Behavioral: Desensitization Therapy Behavioral: Standard Care||Not Applicable|
Once enrolled, each participant will be randomized to one of three groups: the Healing Touch (HT) treatment arm, the Desensitization Therapy (DT) arm, or the no-intervention arm.
Subjects in Group 1 will receive three, 45-minute HT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 2 will receive three, 45-minute DT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 3 will receive no intervention. Subjects in Group 3 will be offered two HT sessions after completing study participation.
All subjects and their partners will be asked to complete the Spielberger State Trait Anxiety Inventory (STAI), the Perceived Stress Scale (PSS) and the Infertility Self-Efficacy Scale (ISES) at three time points: 1) baseline 2) one day prior to oocyte retrieval and 3) 5-7 days post embryo transfer. In addition, subjects in all groups will complete a short pre-study questionnaire to assess expectation of therapeutic effect, and subjects in the two intervention groups will complete a short post-study questionnaire to evaluate their treatment experience. Demographic and pregnancy outcome data will be collected for all subjects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stress Reduction During In Vitro Fertilization|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2011|
- Spielberger State Trait Anxiety Inventory [ Time Frame: 30 days ]
- Perceived Stress Scale [ Time Frame: 30 days ]
- Infertility Self-Efficacy Scale [ Time Frame: 30 days ]
- Pregnancy outcome [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788502
|Contact: Kathy Turner, RN, NP||(650) email@example.com|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Kathy Turner, RN, NP 650-724-6850 firstname.lastname@example.org|
|Principal Investigator: Kathy Turner RN, NP|
|Sub-Investigator: Lynn M Westphal|
|Principal Investigator:||Kathy Turner RN, NP||Stanford University|