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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

November 6, 2008
May 21, 2010
October 2008
December 2010   (final data collection date for primary outcome measure)
Spielberger State Trait Anxiety Inventory [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Spielberger State Trait Anxiety Inventory
Complete list of historical versions of study NCT00788502 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Infertility Self-Efficacy Scale
  • Perceived Stress Scale
  • Pregnancy Outcome
Not Provided
Not Provided
 
Stress Reduction During In Vitro Fertilization
Stress Reduction During In Vitro Fertilization

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • Behavioral: Healing Touch
  • Behavioral: Desensitization Therapy
  • Behavioral: Standard Care
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2011
December 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 42 Years
No
Contact: Kathy Turner, RN, NP (650) 724-6850 kathyt@stanford.edu
United States
 
NCT00788502
SU-11052008-1334, 15402
Not Provided
Kathy Turner RN, NP, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Kathy Turner RN, NP Stanford University
Stanford University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP