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| Sponsored by: |
Stanford University |
|---|---|
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00788502 |
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: Mind-Body Group Counseling Behavioral: Standard CAre |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Healing Touch for Women Undergoing In Vitro Fertilization |
| Estimated Enrollment: | 300 |
| 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 Mind-Body group counseling arm, or the no-intervention arm.
HT treatment arm: Subjects in the HT treatment arm will be scheduled for four weekly 1-hour sessions of HT beginning two to four weeks before they begin their scheduled IVF treatment. Patients usually have at least two or three weeks before treatment commences, as they are placed on an oral contraceptives prior to initiation of ovarian stimulation. These appointments will be scheduled according to the dictations of the patient and the Healing Touch providers, taking into consideration when facilities are available.
Mind-Body group counseling arm: Subjects in this arm will be scheduled to attend four weekly, 90-minute Mind-Body group sessions lead by Penny Donnelly, RN, MFT. These will occur once weekly at a specified time. Participants will attend these four sessions beginning two to four weeks before they begin their scheduled IVF treatment, similar to the HT sessions. The four group sessions will include discussion and practice of the relaxation response, cognitive restructuring, mindfulness meditation, communication skills and resilience.
No-intervention arm: These subjects will not receive any intervention during the pre-ovarian stimulation period.
All subjects 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 timepoints: 1) baseline (at enrollment), 2) the end of their treatment intervention, and 3) 7-10 days post-embryo transfer.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:1) Women undergoing their first IVF cycle at the Stanford IVF Clinic.
2) Age <41 3) Speak and read English
Exclusion Criteria:1) Undergoing IVF at an institution other than Stanford University 2) Women who are identified as having diminished ovarian reserve. 3) Women planning on utilizing other energy work interventions during their IVF cycle, such as Healing Touch, Reiki, QiGong, or acupuncture.
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Kathy Turner RN, NP | Stanford University |
More Information
| Responsible Party: | Stanford University School of Medicine ( Kathy Turner, RN, NP ) |
| Study ID Numbers: | SU-11052008-1334, 15402 |
| Study First Received: | November 6, 2008 |
| Last Updated: | April 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00788502 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Genital Diseases, Female Infertility Genital Diseases, Male |
|
Genital Diseases, Female Infertility Genital Diseases, Male |
