Stress Reduction During In Vitro Fertilization
Recruitment status was Recruiting
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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.
| Condition | Intervention |
|---|---|
|
Infertility |
Behavioral: Healing Touch Behavioral: Desensitization Therapy Behavioral: Standard Care |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 45 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 42 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Kathy Turner, RN, NP | (650) 724-6850 | kathyt@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Kathy Turner, RN, NP 650-724-6850 kathyt@stanford.edu | |
| Principal Investigator: Kathy Turner RN, NP | |
| Sub-Investigator: Lynn M Westphal | |
| Principal Investigator: | Kathy Turner RN, NP | Stanford University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kathy Turner RN, NP, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00788502 History of Changes |
| Other Study ID Numbers: | SU-11052008-1334, 15402 |
| Study First Received: | November 6, 2008 |
| Last Updated: | May 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013