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Stress Reduction During In Vitro Fertilization

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ClinicalTrials.gov Identifier: NCT00788502
Recruitment Status : Unknown
Verified May 2010 by Stanford University.
Recruitment status was:  Recruiting
First Posted : November 11, 2008
Last Update Posted : May 24, 2010
Sponsor:
Information provided by:
Stanford University

Brief Summary:
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 or disease Intervention/treatment
Infertility Behavioral: Healing Touch Behavioral: Desensitization Therapy Behavioral: Standard Care

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stress Reduction During In Vitro Fertilization
Study Start Date : October 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Spielberger State Trait Anxiety Inventory [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Perceived Stress Scale [ Time Frame: 30 days ]
  2. Infertility Self-Efficacy Scale [ Time Frame: 30 days ]
  3. Pregnancy outcome [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788502


Contacts
Contact: Kathy Turner, RN, NP (650) 724-6850 kathyt@stanford.edu

Locations
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         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kathy Turner RN, NP Stanford University

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
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: May 24, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female