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Stress Reduction During In Vitro Fertilization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00788502
First received: November 6, 2008
Last updated: May 21, 2010
Last verified: May 2010
  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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Spielberger State Trait Anxiety Inventory [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 20, 2014