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Healing Touch During In Vitro Fertilization
This study is currently recruiting participants.
Verified by Stanford University, December 2008
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

MedlinePlus related topics: Anxiety Infertility
U.S. FDA Resources
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

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Spielberger State Trait Anxiety Inventory

Secondary Outcome Measures:
  • Infertility Self-Efficacy Scale
  • Perceived Stress Scale
  • Pregnancy Outcome

Estimated Enrollment: 300
Study Start Date: October 2008
Detailed Description:

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
Criteria

Inclusion Criteria:1) Women undergoing their first IVF cycle at the Stanford IVF Clinic.

2) Age <41 3) Speak and read English&#xA; Exclusion Criteria:1) Undergoing IVF at an institution other than Stanford University 2) Women who are identified as having dimished 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788502

Contacts
Contact: Margaret F Reynolds-May, B.A. (650) 498-7625 margaret.reynolds@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Margaret F Reynolds-May, B.A.     650-498-7625     margaret.reynolds@stanford.edu    
Principal Investigator: Kathy Turner RN, NP            
Sub-Investigator: Lynn M Westphal            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kathy Turner RN, NP Stanford University
Sub-Investigator: Lynn M Westphal Stanford University
  More Information

Stanford Reproductive Endocrinology and Infertility Division Webpage.  This link exits the ClinicalTrials.gov site
Stanford Women's Health Program Webpage.  This link exits the ClinicalTrials.gov site

Study ID Numbers: SU-11052008-1334, 15402
Study First Received: November 6, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00788502  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 16, 2009