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OpenTrials
Completed

NCT Number: NCT00788502

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Not planning to use concomitant energy work interventions (HT, Reiki, QiGong, acupuncture)during the IVF cycle.

Treatment and study plan

Healing Touch

Behavioral

Desensitization Therapy

Behavioral

Primary outcomes

  1. Spielberger State Trait Anxiety Inventory

    Time frame: 30 days

Secondary outcomes

  1. Perceived Stress Scale

    Time frame: 30 days

  2. Infertility Self-Efficacy Scale

    Time frame: 30 days

  3. Pregnancy outcome

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 11, 2008
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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