View Clinical Trial (Medical Research Study)
Stress Reduction During In Vitro Fertilization
| City: |
|
Stanford |
| State: |
|
California |
| Zip Code: |
|
94305 |
| Conditions: |
|
Infertility |
| Purpose: |
|
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.
|
| Study Summary: |
|
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.
|
| Criteria: |
|
Inclusion Criteria:-Age <43
- FSH <= 14
- About to enter an IVF cycle at the Stanford Fertility and Reproductive Medicine
Center
- Planning a transfer of their own fresh embryos during this cycle
- Speak and read English fluently
Exclusion Criteria:-Diminished ovarian reserve
- Planning to freeze their embryos without embryo transfer during this cycle
- Planning to use donor eggs or embryos during this cycle
- Concomitant energy work interventions (HT, Reiki, QiGong, acupuncture) planned
during the IVF cycle.
|
| NCT ID: |
|
NCT00788502 |
| Primary Contact: |
|
Principal Investigator Kathy Turner RN, NP Stanford University
Kathy Turner, RN, NP Phone: (650) 724-6850 Email: kathyt@stanford.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Stanford, California 94305 United States
Kathy Turner, RN, NP Phone: 650-724-6850 Email: kathyt@stanford.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 19, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|