Stress Reduction During In Vitro Fertilization
Recruitment status was Recruiting
The goal of this study is to determine the effect of Healing Touch (HT) on the stress, anxiety, and self-efficacy experiences of women undergoing in vitro fertilization (IVF) in a randomized, controlled design. HT is a gentle, non-invasive form of energy-balancing work that promotes relaxation.
Behavioral: Healing Touch
Behavioral: Desensitization Therapy
Behavioral: Standard Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Stress Reduction During In Vitro Fertilization|
- Spielberger State Trait Anxiety Inventory [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Perceived Stress Scale [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Infertility Self-Efficacy Scale [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Pregnancy outcome [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788502
|Contact: Kathy Turner, RN, NP||(650) firstname.lastname@example.org|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Kathy Turner, RN, NP 650-724-6850 email@example.com|
|Principal Investigator: Kathy Turner RN, NP|
|Sub-Investigator: Lynn M Westphal|
|Principal Investigator:||Kathy Turner RN, NP||Stanford University|